REMERON & SEROQUEL: Robin Williams July 21, 1954 – August 11, 2014

ROBIN WILLIAMS Born: July 21,1951 Died: August 11, 2014

This weekend should not pass us by without addressing the anniversary of the passing of one of the greatest comedians of all time, Robin Williams. He died three years ago of Antidepressant-induced REM Sleep Disorder (RBD). He had at least 2 serotonergic drugs in his system when he killed himself.

One antidepressant found in Robin Williams toxicology test, Mirtazapine, Remeron, has 10 drug regulatory agency warnings citing suicidal ideation.

The mainstream media are reporting that Robin Williams had no drugs in his system when he died, but what they mean is no ‘illegal drugs’. He did have two serotonergic prescription medications in his system, these are legal drugs, and they can often be worse than street drugs as many users will attest to and which have long been known to produce LSD effects and even test positive for PCP. Sadly these (side) effects are not as well known by the public, nor their physicians. But we do know that the hallucinogenic effects of LSD and PCP are brought on by their mimicking of serotonin – the very chemical these serotonergic medications are designed to increase. As a result SSRI’s, SNRI’s, tricyclic antidepressants, MAI’s, atypical antipsychotics, or any other drug which increases serotonin levels can cause all sorts of problems, from inducing self harm, mania, akathisia, suicidal ideation, aggression, homicidal thoughts etc… Anyone on them long-term is asking for trouble…but even short term they can cause all sorts of nasty side effects as was demonstrated in the courtroom verdict finding only two doses of the antidepressant Paxil to be the main cause of the mass murder/suicide of the Donald Schell family in Wyoming in 2001. (Tobin vs Glaxo)

Thanks to Alex Steblowsky for sharing much of this information with links. https://truthman30.wordpress.com/2014/11/08/robin-williams-had-2-antidepressants-in-his-system-when-he-killed-himself-autopsy-reveals/

This weekend should not pass us by without addressing the anniversary of the passing of one of the greatest comedians of all time, Robin Williams. He died three years ago of Antidepressant-induced REM Sleep Disorder (RBD). This is a disorder I wrote about almost three decades ago in my book on about antidepressants, Prozac: Panacea or Pandora? – Our Serotonin Nightmare! as being the most deadly side effect, or abrupt withdrawal effect, of antidepressants . Here is our Facebook group by that name on this disorder where one acts out their worst nightmare in a sleep state:

Facebook Group: Antidepressant-induced REM Sleep Disorder

https://www.facebook.com/groups/106704639660883/

Although his wife amazingly was able to track down what it was that drove him to take his life – a REM Sleep Disorder, she attributed it to Lewy Bodies, not knowing how common RBD is to antidepressant use nor the fact that the overwhelming majority of RBD cases, 86%, are diagnosed in those taking an antidepressant.

But Robin was not on just one, but two of these drugs which produce this deadly sleep disorder known to cause the patient to hurt themselves or someone else in 80% of the cases (including both murder and suicide) as they act out these drug-induced nightmares.

Our Facebook groups for the antidepressant and atypical antipsycotic Robin was taking, which we firmly believe need to be pulled from the market….

Facebook Group: Remeron (Mirtazapine) Should Be Illegal

https://www.facebook.com/groups/RemeronandMirtazapine/?ref=br_rs

Facebook Group: Seroquel (Quetiapine) Should Be Illegal

https://www.facebook.com/groups/605535796261627/

The mainstream media are reporting that Robin Williams had no drugs in his system when he died, but what they mean is no ‘illegal drugs’.

So what was his prescription drug history? What all had he been given as he was treated for depression, Bipolar, etc. What doses were they? And how long was he on them? How rapidly was he taken off them? All these things can contribute to this final tragic outcome. I firmly believe Robin’s family deserve to know the truth about the dangers all the prescription drugs he had been given…

Some news sites are reporting the name of the atypical antipsychotics he was given as, Seroquel.

“When authorities found Robin’s body … they saw a closed bottle of Seroquel, a drug that treats schizophrenia, bipolar disorders and depression. It was prescribed a week before he died.

This news site is reporting, Seroquel (an atypical anti-psychotic and the antidepressant, mirtazapine (Remeron Zispin)

http://www.drugs.com/remeron.html

“In general, some antidepressants, especially SSRIs, can paradoxically exacerbate some peoples’ depression or anxiety or cause suicidal ideation.[55] Despite its sedating action, mirtazapine is also believed to be capable of this, and for this reason in the United States and certain other countries it carries a black box label warning of these potential effects.”

http://en.wikipedia.org/wiki/Quetiapine

Both classes of these types of drugs all carry Black Box warning labels for suicide.

There is an emerging controversy regarding quetiapine fatalities. The deaths of at least six U.S. military veterans who were given drug cocktails including quetiapine[31] have been attributed to its inclusion by military doctors to treat PTSD.

Approximately 10,000[32] lawsuits[33][34][35][36][37] against AstraZeneca for problems ranging from slurred speech and chronic insomnia to death have been filed by individuals from civilian populations.

Some have argued that additional somatic and psychiatric symptoms associated with dopaminergic super-sensitivity, including dyskinesia and acute psychosis, are common features of withdrawal in individuals treated with neuroleptics.[48][49][50][51] This has led some to suggest that the withdrawal process might itself be psychosis-mimetic, producing psychotic-like symptoms even in previously healthy patients, indicating a possible pharmacological origin of mental illness in a yet unknown percentage of patients currently and previously treated with antipsychotics.

Read more: http://www.tmz.com/2014/11/07/robin-williams-autopsy-results-drugs-depression-suicide-parkinsons/#ixzz3IRUsdkWz
http://perezhilton.com/2014-11-07-robin-williams-autopsy-results-revealed-suicide-parkinson-anxiety-paranoia/?from=post#.VF2FmNYjlo4

The first thing is that Robin was sober at the time of his death. The report stated that he only had four drugs in his system, two were anti-depressants and two were “caffeine compounds.”

However, the report also brought to light the fact that Robin was suffering from paranoia [yet another side effect of these serotonergic medications] and apparently he …

“placed several wrist watches in a sock and gave them to someone because he was worried about their safe keeping.”

_______________________

Ben Stein: Anti-depressants Gave Me Suicidal Thoughts
CBNNews.com
Monday, August 25, 2014

Tonight’s Emmy Awards will feature a tribute to iconic comedian and actor Robin Williams, who recently committed suicide after a lifelong battle with depression.

Like Williams, actor Ben Stein told CBN News he also struggled with depression and thoughts of suicide.

It’s unclear whether Williams took anti-depressants. But Stein said those drugs played a dangerous role in his personal battle with depression. He said the closest he came to actually taking his own life were the times he was taking anti-depressants.

“The absolute worst I’ve ever felt in my entire life was under the influence of two drugs called Thorazine and Mellaril,” he said. “That was a long, long time ago, when they were supposed to make you feel better and yet, suicidal thoughts – they had the exact opposite effect and I really came close to death,” Stein told CBN Health and Science reporter Lorie Johnson.

“And then within the last several years, a drug called Wellbutrin, which is a well-known anti-depressant was prescribed to me and it actually worked quite well for about two weeks. And then I felt an overwhelming compulsion to commit suicide and I stopped taking it and it went away,” Stein said.

Stein said he has kept his depression and thoughts of suicide at bay through prayer, rest, and fresh air, and getting in a 12-step program.

“Unless there’s some gigantic breakthrough I’m unaware of, I would never think of touching anti-depressants again. That being said, if they work for other people, God bless ’em,” Stein said

https://truthman30.wordpress.com/2014/11/08/robin-williams-had-2-antidepressants-in-his-system-when-he-killed-himself-autopsy-reveals/

E-mail : truthman30@gmail.com

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RADIO SHOW: ANTIDEPRESSANTS IN THE MILITARY & ANDREA YATES CASE

Radio Show Monday: Ann Blake Tracy on “The Power Hour” with Captain Joyce Riley

powerhourbanner2

Ann Blake Tracy, Executive Director of the International Coalition for Drug Awareness (www.drugawareness.org and www.ssristories.NET) will be on the international radio show “The Power Hour” with Captain Joyce Riley tomorrow morning, March 9, 2015, from 8:00 – 9:00 AM Central Time. You can access the show on the web from around the world at http://www.thepowerhour.com/ The subject of course will be antidepressants and since Joyce has long been the most vocal advocate for veterans in the country over the past two and a half decades we will be discussing the problems within the military as a result of the high antidepressant use among vets.

Immediately following the interview with Ann Blake Tracy will be a live interview with George Parnham the attorney for Andrea Yates, the Texas mother who drowned her five children as a result of taking the antidepressants Effexor and Remeron and having both abruptly and drastically changed (dropping one by 1/3 of the dose and increasing the other by 1/4 of the dose) just the day before – something the FDA warns can produce suicide, hostility or psychosis.

Without doubt Andrea suffered the REM Sleep Disorder, long known to be the most dangerous withdrawal effect of antidepressants where you act out nightmares in an unconscious state. It has been found that 86% of those being diagnosed with this deadly sleep disorder are currently taking an antidepressant, yet no research has been done to show the percentage of those in withdrawal from antidepressants who are suffering REM Sleep Disorder. Rusty will tell you in a heartbeat that losing their children was without any doubt Andrea’s worst nightmare. The children were her life. She had even quit her nursing career to spend all of her time with them.

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Five Small White Coffins Carry the Yates Children

Ann Blake Tracy, Executive Director,

International Coalition for Drug Awareness

www.drugawareness.org & http://ssristories.net Complete Truth of the Full Impact of Antidepressants Upon Us & Our World” & Withdrawal CD “Help! I Can’t Get Off My Antidepressant!”

WITHDRAWAL WARNING: In sharing this information about adverse reactions to antidepressants I always recommend that you also give reference to my CD on safe withdrawal, Help! I Can’t Get Off My Antidepressant!, so that we do not have more people dropping off these drugs too quickly – a move which I have warned from the beginning can be even more dangerous than staying on the drugs!

WITHDRAWAL HELP: You can find the hour and a half long CD on safe and effective withdrawal helps here: http://store.drugawareness.org/ And if you need additional consultations with Ann Blake-Tracy, you can book one at www.drugawareness.org or sign up for one of the memberships for the International Coalition for Drug Awareness which includes free consultations as one of the benefits of that particular membership plan.

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COLD TURKEY WITHDRAWAL = TRIPOLAR MESS

withdrawal

COLD TURKEY WITHDRAWAL = TRIPOLAR MESS = QUICK TRIP TO HELL

Note: Thank you so very much to Nick Cole for sharing this most important information on the dangers of cold turkey withdrawal from these deadly mind altering medications!!!! As we have warned for two decades coming off these drugs too quickly can even be worse than staying them! (And if you have educated yourself on the effects of these drugs you know how deadly staying on them can be!)

Three years ago today, I checked myself into rehab for prescribed iatrogenic benzodiazepine and psych drug dependence. Not knowing any better and without support to come off of the drugs (that I finally KNEW were the cause of all my years of illness) from my doctor, I allowed them to cold-turkey me from six psychiatric drugs (Klonopin, Xanax, Ambien, Remeron, Seroquel, Adderall). Within months, I was suicidal and psychotic and could no longer cope in that condition.

Going to rehab was the second biggest mistake in my life; the first was ever taking this poison in the first place. They treated me horribly, like a street-junkie and called me an addict, forced me to AA/NA meetings – for medications that my doctor prescribed for me and told me to take regularly for my supposed “mental illness”. What they did to me was criminal, barbaric and medically unsound.

I attempted to reinstate the benzo only (I stayed off of the others) to taper with minimal success, as 4 months had passed in the cold-turkey state and the drugs don’t always work again that far off from a CT. I tapered off of the Valium that I reinstated and have been off for almost 10 months.

Everyday is still a living hell where I’m bed-bound for the majority of the day. I wouldn’t wish this on anyone (except maybe the psychiatrist who is responsible for this inhumane suffering). I am in severe pain, have DP/DR, cognitive dysfunction, a sensation that I’m “on a boat out to sea”, nausea, blurred vision, mood swings, depression and a plethora of other debilitating symptoms with no end in sight. I can barely physically take care of myself and I live alone with no in-person support. I cannot work. I lost my home, my friends, my family and everything that was of any value to me, other than my life which I came scarily close to losing too.

PLEASE DO NOT allow anyone to cold-turkey you from psychiatric drugs. You will be at risk for a severe, protracted withdrawal syndrome that could last for YEARS. Do your research and homework and find someone who has knowledge of tapering these medications to guide you. If your doctor tries to rush you off of your medications- FIND ANOTHER DOCTOR that will support you in a slow taper at a speed your body can tolerate.

I can only hope that with more time I will see more improvements and functionality. Psychiatric drugs are toxic poison which disable the brain and CNS.

The worst part is that I didn’t need ANY of these medications. I allowed a doctor to label me, to drug me and to destroy my life over “work-related stress” which spiraled into polydrugging with multiple psych meds because the more drugs that were added, the more I experienced tolerance and side effects that were MISdiagnosed by a pill-pushing psychiatrist as “mental illness”. It can happen SO easily to anyone who’s vulnerable, trusting and uneducated about the destructive nature of these medications. I thought the same as SO many other psych drug victims- “Surely, my doctor wouldn’t prescribe me something harmful”. I was very terribly WRONG. And when I became sick from the medication, the medical community not only abandoned me as a patient but blamed me for my own suffering.

It is my hope that before I die that we see the “psychiatric drug bubble” burst and the truth revealed about these noxious poisons that are being handed out all over the world to innocent unsuspecting people and children. Until then, I will not give up. I will fight to continue to spread the word about these drugs and the people who prescribe them. And I will continue to fight to reclaim my health that was unfairly stolen from me.

Thank you to everyone in the psych drug withdrawal communities online who have befriended me, supported me and loved me when the rest of the world turned their backs on me, blamed me and wrote me off as “mentally ill” or “not trying hard enough”. Thank you for your validation and for sharing your stories and experiences so candidly so that others can learn from you and not make the same mistakes. All of you are the biggest warriors I have ever met. I wouldn’t be alive today without your support and friendship. You know who you are and I am so grateful for you.

For anyone going through this – keep going. I’m told we all recover and heal with time. As hard as it is, it has to be worth it to be medication-free and healthy; out from underneath the control of doctors and their “medicines”.

Peace and continued healing to each and everyone of you. Much love.

You never know what you’re gonna get…Thank you Psychiatry and Big Pharma. For turning me into a tripolar MESS.

Nick Cole

WARNING: In sharing this information about adverse reactions to antidepressants and dangers of cold turkey withdrawal any mind altering medication I always recommend that you also give reference to my CD on safe withdrawal, Help! I Can’t Get Off My Antidepressant [or Benzo, or Atypical Antipsychotic]!, so that we do not have more people dropping off these drugs too quickly – a move which I have warned from the beginning can be even more dangerous than staying on the drugs! Done correctly withdrawal does not have to be painful and dangerous.

The FDA also now warns that any abrupt change in dose of an antidepressant can produce suicide, hostility or psychosis. And these withdrawal reactions can either come on very rapidly or even be delayed for months depending upon the adverse effects upon sleep patterns due to the rapid withdrawal!

You can find the CD on safe and effective withdrawal helps here: http://store.drugawareness.org/

Ann Blake Tracy, Executive Director,
International Coalition for Drug Awareness
www.drugawareness.org & http://ssristories.drugawareness.org
Author: ”Prozac: Panacea or Pandora? – Our Serotonin Nightmare – The Complete Truth of the Full Impact of Antidepressants Upon Us & Our World” & Withdrawal CD “Help! I Can’t Get Off My Antidepressant!”

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ON MEDS: LAS VEGAS DESERT STORM VET SHOOTS DAUGHTER (25) AND SELF

amanda landis

Amanda Landis

Comment from local news media KTNV TV by Ann Blake-Tracy · Top Commenter · Executive Director, International Coalition for Drug Awareness (www.drugawareness.org) at Executive Director, International Coalition for Drug Awareness

“After over two decades of tracking murder/suicides, school shootings, workplace violence and mothers killing their children I can say without hesitation that the answer to this tragedy lies in the prescription drugs the father was taking especially when he was likely being medicated by the VA.

From the article below we read: “Jenice said her husband, who was a Desert Storm vet, had recently been taking prescription drugs and may have been drinking following the argument.”

“I have a current case of diagnosed “homicidal ideation” produced by the antidepressants Celexa and Remeron in a young military man. I am absolutely shocked by the multiple drugs they handed out like candy to him that all interact negatively and then refused to give them for weeks at a time when the FDA has warned that any abrupt change in dose of an antidepressant, whether increasing or decreasing, can cause suicide, hostility or psychosis!

“The large number of murder/suicides in those you would never expect such behavior from is epidemic and shocking and almost always related to antidepressants or other serotonergic medications!!!”

WARNING: In sharing this information about adverse reactions to antidepressants I always recommend that you also give reference to my CD on safe withdrawal, Help! I Can’t Get Off My Antidepressant!, so that we do not have more people dropping off these drugs too quickly – a move which I have warned from the beginning can be even more dangerous than staying on the drugs!

The FDA also now warns that any abrupt change in dose of an antidepressant can produce suicide, hostility or psychosis. And these reactions can either come on very rapidly or even be delayed for months depending upon the adverse effects upon sleep patterns when the withdrawal is rapid! You can find the CD on safe and effective withdrawal helps here: http://store.drugawareness.org/

Ann Blake Tracy, Executive Director,
International Coalition for Drug Awareness
www.drugawareness.org & http://ssristories.drugawareness.org
Author: *”Prozac: Panacea or Pandora? – Our Serotonin Nightmare – The Complete Truth of the Full Impact of Antidepressants Upon Us & Our World” & Withdrawal CD “Help! I Can’t Get Off My Antidepressant!”

MOTHER INTERVIEWED IN LAS VEGAS MURDER/SUICIDE OF HUSBAND AND DAUGHTER

North Las Vegas, NV (KTNV) — The North Las Vegas woman who watched her husband kill himself, just moments after he killed their 25-year-old daughter is speaking out.

“I just hate that they are saying it was a heated family argument. It wasn’t. It was four and a half, five hours later,” Jenice Landis said.

Jenice said she is still trying to figure out how an argument over housework at midnight led her husband, Greg, to kill their daughter, Amanda then himself Sunday morning.

“I just told him, ‘Greg I’m really not feeling good. I really need to sleep can we do this tomorrow. I know this is a ridiculous argument you are having with me.’ And Amanda woke up and said, ‘Dad, leave her alone and let her sleep.’ That is about all there was to the argument,” Jenice said.

Jenice and her daughter were staying in the same room while Jenice recovered from surgery.
They both went to sleep only to be jolted awake around 5 a.m.

“I woke up to gunfire and flashes and gun smoke. I rolled off the bed and I know that is the only reason I am alive, because I felt gunshots going by me and I looked at my daughter and he had shot her in the chest and her chest was nothing but blood and gore,” Jenice said.

Jenice then said her 52-year-old husband turned the gun on himself, leaving her to wonder how the man she was married to for 27 years could do such a thing.

“I didn’t think my husband would ever hurt one of his children. He wasn’t that person,” Jenice said.

Jenice said her husband, who was a Desert Storm vet, had recently been taking prescription drugs and may have been drinking following the argument.

Police said they will not be able to confirm that until they get toxicology results back. For now, Jenice and Amanda’s twin brother are just working to cope with the loss.

“My daughter was a beautiful creature and her life ended way too soon, and I don’t want people to ruin that celebration of her life that we are going to have,” Jenice said.

North Las Vegas Police are not releasing many details about the murder-suicide or details about the fight, saying it is too early in the investigation.

Original article: http://www.ktnv.com/news/local/Mother-speaks-out-about-murder-suicide-223050761.html

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ZOLOFT: MULTIPLE LAWSUITS FILED FOR MULTIPLE BIRTH DEFECTS

Zoloft-mother-and-child[1]

ZOLOFT: MULTIPLE LAWSUITS FILED FOR MULTIPLE BIRTH DEFECTS

I do not believe it is clear to many people how serious these SSRI birth defect cases really are. This is to give you an idea of just how serious the birth defect cases are going against these drug companies…

Child was born with multiple birth defects…The complainant states that she took Zoloft throughout her pregnancy after it was prescribed by her treating physicians. She gave birth to a child with numerous congenital birth defects. The baby has been diagnosed with spina bifida, scoliosis, vater syndrome, tracheoesophageal fistula, and mitral valve regurgitation.

CASE #1

New Jersey Woman Files Zoloft Birth Defects Lawsuit

Perry Larkin | November 6th, 2012 | Posted in Zoloft Lawsuits

A New Jersey woman filed a new Zoloft litigation on October 17, 2012 seeking damages against manufacturer Pfizer, Inc. According to the filing the woman took the antidepressant Zoloft during her pregnancy and it caused multiple birth defects in her newborn son.

The case was filed in the U.S. District Court, Southern District of New York (Foley Square). She makes complaints of product liability, defective design, failure to warn, negligence and misrepresentation and seeks punitive and actual damages.

Zoloft accused of showing “willful disregard” to informing the public of risks

According to studies, Zoloft has long been linked to birth defects in newborns. In spite of FDA regulations that the new medical evidence requires Pfizer to update the warning label, the company has yet to do so.

The plaintiff’s attorney states that the company showed a willful disregard to informing the medical community and public of the risk of congenital birth defects due to Zoloft and this caused permanent harm to his client’s son. The label still fails to warn of the dangers and risks of congenital birth defects of Zoloft if it’s taken during pregnancy.

The plaintiff claims that her baby suffered from the following side effects of Zoloft: spina bifida, vater syndrome, clubfoot and other related defects.

Pfizer alleged to have known of side effects as early as 2007

The lawsuit alleges that Pfizer carelessly marketed the product and failed to provide sufficient warning as to the possible side effects to pregnant women. This case joins other designated cases for the pilot program of the district court, which aims to address complex civil cases.

The complaint says that in 2007, Pfizer knew that selective serotonin reuptake inhibitors (SSRIs) like Zoloft doubled the risk of septal heart defects in babies who were born to mothers who took the medication. In studies published in the New England Journal of Medicine, it indicates that a four-fold increase in heart defects was connected to pregnant women using Zoloft during their first trimester. Other studies showed that using the medication while pregnant is also linked to a higher occurrence of heart malformation.

Child was born with multiple birth defects

The complainant states that she took Zoloft throughout her pregnancy after it was prescribed by her treating physicians. She gave birth to a child with numerous congenital birth defects. The baby has been diagnosed with spina bifida, scoliosis, vater syndrome, tracheoesophageal fistula, and mitral valve regurgitation.

The plaintiff seeks compensation for medical costs, as well as punitive and special damages.

injurylawyer-news.com/2012/11/new-jersey-woman-files-zoloft-birth-defects-lawsuit/

CASE #2

Zoloft Caused Daughter’s Birth Defects, Tennessee Parents Claim in Lawsuit

Tracy Ray | October 24th, 2012 | Posted in Zoloft Lawsuits

In a lawsuit against Pfizer that was recently added to the Zoloft MDL, parents Michael and Shana Reid of Tennessee charge that their daughter was born with birth defects resulting from Zoloft. The Reids originally filed their lawsuit on June 8, 2012, in the Court of Common Pleas in Philadelphia County, and the case was transferred to the Zoloft MDL in the U.S. District Court, Eastern District of Pennsylvania, on August 16, 2012.

Baby needed surgery for life-threatening defects

According to the Reid’s lawsuit, Shana Reid was prescribed Zoloft by her physician during her pregnancy. She read the drug’s warning label, but did not see anything about birth defects, so she trusted that the antidepressant was safe to use while pregnant. Had she been warned about the risk of birth defects resulting from Zoloft, she would not have taken it during her pregnancy, she states in the lawsuit.

The Reid’s baby was born on October 14, 2004 with life-threatening congenital birth defects, the lawsuit states. As a result, the child has undergone corrective surgery and is likely to require further surgeries in future.

Plaintiffs accuse Pfizer of failure to warn mothers of Zoloft’s risks

The Reid’s lawsuit alleges that Pfizer was aware of the risk of side effects after taking Zoloft, but failed to adequately warn the public or the medical community. Their lawsuit charges that Pfizer’s marketing and advertising for Zoloft misled pregnant women and their doctors by giving inaccurate or misleading information about the danger Zoloft poses to a fetus when the drug is taken during pregnancy.

The lawsuit bring counts of failure to warn, design defect, fraud, negligence, gross negligence, negligent design, and breach of warranties. The plaintiffs are seeking compensation in excess of $75,000 in damages.

FDA issued warning about Zoloft birth defects

The FDA issued a warning in July 2006 stating that studies had shown that babies born to mothers who took Zoloft or other SSRI antidepressants during pregnancy were six times more likely to be born with PPHN than babies born to mothers who did not take antidepressants.
The following year, a 2007 study published in the New England Journal of Medicine found that women who took Zoloft during the first trimester had double the risk of giving birth to an infant with heart defects, compared to those who did not take antidepressants.

injurylawyer-news.com/2012/10/zoloft-caused-daughters-birth-defects-tennessee-parents-claim-in-lawsuit/

CASE #3

A Lawsuit Alleging Birth Defects From Zoloft is Filed in Pennsylvania
Perry Larkin | October 15th, 2012 | Posted in Zoloft Lawsuits
On September 10, 2012, a new lawsuit alleging birth defects from the use of Zoloft while pregnant was filed on behalf of ten plaintiffs by Zoloft attorneys. The case, Lentz et. Al. v. Pfizer Inc., was filed in the U.S. District Court for the Eastern District of Pennsylvania and alleges that the antidepressant Zoloft (sertraline) is responsible for the birth defects in their children.

This lawsuit joins the increasing number of plaintiffs who are seeking compensation for the alleged problems as a result of the medication.

Pfizer is accused of knowing of the risk of birth defects and failing to alert the public

The lawsuit alleges that Pfizer knew of the possibility of birth defects from preclinical and published studies and took no action to properly study the drug and its aftereffects. In addition, they chose not to publish these studies due to the revelation of increased risks with the drug. The manufacturer is accused of concealing, suppressing the results, and failing to warn consumers of the potential dangers. Pfizer continues to deny these accusations.

Many side effects from Zoloft can affect the heart, the gastrointestinal system, and cranial malformations

The children were born between 1998 and 2011. A correlation was demonstrated in studies between 2007 and 2009 that indicated the increased risk of birth defects when women take Zoloft while pregnant, but the plaintiffs were unaware of these studies. The plaintiffs claim that if they’d known of the risks, they never would have taken the drug.
Some of the side effects resulting from Zoloft use described in the lawsuit include gastrointestinal problems such as anteriorly displaced anus and omphalocele; heart defects such as right-sided aortic arch, patent ductus arteriosus, cleft mitral valve, transposition of the great arteries, atrial and ventrical septal defects, anomalous pulmonary venous return, and aotrtic stenosis; and craniofacial malformations such as cleft lip and palate, and multiple-suture craniosynostosis.

Pfizer’s safety information posted online doesn’t mention birth defects
On their website, Pfizer has posted “Important Safety Information” about possible complications of Zoloft, but doesn’t specifically mention birth defects. The site does state that “[w]omen who are pregnant, plan to become pregnant, or who are breastfeeding should not take any antidepressant without consulting their doctor,” but to date doesn’t acknowledge any risk of birth defects, nor does it indicate that Zoloft poses any risk to a pregnancy that other antidepressants don’t also pose.

injurylawyer-news.com/2012/10/a-lawsuit-alleging-birth-defects-from-zoloft-is-filed-in-pennsylvania/

CASE #4

Zoloft Drugmaker Blamed for Child Death

Elise Kramer | October 11th, 2012 | Posted in Zoloft Lawsuits

A New York couple has filed a lawsuit against Zoloft drug maker Pfizer, claiming that the antidepressant Zoloft is responsible for the birth defects experienced by their deceased son. The lawsuit was filed on August 17, 2012, in the United States’ District Court for the Eastern District of Pennsylvania, where the current Zoloft multidistrict litigation case is taking place. Jessica and Shawn Coon are claiming that Zoloft was responsible for the side effects experienced by their child, as Jessica took the medication during her pregnancy; they claim that they were not adequately informed of potential side effects associated with the medication at the time.

Negligence claimed by couple

The plaintiffs claim that the deceased minor, known as J.A.C., was born with congenital heart defects caused by birth defects after Zoloft use. He passed away just one month after he was born at the West Chester Medical Center in New York. They claim that because of Pfizer’s negligence and misrepresentation, Jessica Coon continued to take the SSRI drug Zoloft while she was pregnant with her child, which resulted in the birth defects he suffered and in his subsequent death.

The lawsuit claims that Pfizer and its subsidiaries, including Greenstone LLC, did not demonstrate reasonable care in the production, marketing, and distribution of their antidepressant, which caused a number of patients to suffer from birth defects as a result of the drug’s use by pregnant mothers. A number of studies have shown that Zoloft can be linked to an increased risk in birth defects, including PPHN and congenital heart disorders, which can be fatal in serious cases.

Numerous birth defects associated with antidepressant

The growing number of plaintiffs who have chosen to file a birth defects lawsuit related to Zoloft indicates the serious concern about birth defects related to the drug. Studies published in the New England Journal of Medicine revealed that infants born to women taking SSRI medications such as Zoloft were 50 percent more likely to develop heart defects and other serious heart problems.

injurylawyer-news.com/2012/10/zoloft-drugmaker-blamed-for-child-death/

About the Author: Ann Blake Tracy is the author of PROZAC: PANACEA OR PANDORA? –OUR SEROTONIN NIGHTMARE!, and the director of the International Coalition For Drug Awareness [www.drugawareness.org]. She has testified before the FDA and has testified as an expert in legal cases involving serotonergic medications since 1992.

BOOK: Prozac: Panacea or Pandora? – Our Serotonin Nightmare! Anything you ever wanted to know about antidepressants is there along with everything drug companies hope you never find out about these drugs. SAFE WITHDRAWAL CD “Help! I Can’t Get Off My Antidepressant!” on how to safely withdraw from antidepressants & most psychiatric medications is saving lives! Both available at www.drugawareness.org

BOOK TESTIMONIALS:

“Very bold & informative”

“Priceless information that is giving me back to me”

“The absolute best reference for antidepressant drugs”

“Well documented & scientifically researched”

““I was stunned at the amount of research Ann Tracy has done on this subject. Few researchers go to as much trouble aggressively gathering information on the adverse reactions of Prozac, Zoloft and other SSRIs.”

WITHDRAWAL HELP CD TESTIMONIALS:

“Ann, I just wanted to let you know from the bottom of my heart how grateful I am God placed you in my life. I am now down to less than 2 mg on my Cymbalta and I have never felt better. I am finally getting my life back. I can feel again and colors have never been brighter. Thanks for all that you do!!” … Amber Weber

“Used your method of weaning off of SSRI’s and applied it to Ambien. Took 6 months but had been on 15 mg for years so what was another 6 months. I have been sleeping without it for 2 weeks and it is the first time I have been able to sleep drug free for 15 years. What a relief to be able to lay down and sleep when I need or want to. Ambien may be necessary for people at times but doctors giving a months worth of it at a time with unlimited refills is a prescription for disaster. It is so damn easy to become dependent on. Thanks for your council Ann.”… Mark Hill

“I’m so thankful for AnnTracy and all her work. Also for taking the time out to talk to me and educate everyone! She has been a blessing to me during this awful time of antidepressant hell!” … Antoinette Beck

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TWO SOLDIERS PRESCRIBED 54 DRUGS: MILITARY MENTAL HEALTH “TREATMENT” BECOMES FRANKENPHARMACY

andrew-white[1]

Marine Corporal Andrew White was prescribed

19 mind altering drugs in less than one year in the military

which led to his sudden death while home asleep in his bed.

The second article in a four part series by Kelly Patricia O’Meara addressing the over drugging of our military just came out entitled “Two Soldiers Prescribed 54 Drugs: Military Mental Health “Treatment” Becomes Frankenpharmacy” See the article link below:

Although this is a horrible situation in America with suicides outnumbering combat deaths due to the widespread use of these deadly drugs in our military, this is going on in many countries. Even Osama Bin Laden’s son has been diagnosed schizophrenic after his doctors said it was caused by his use of antidepressants. The LA Times reporter who did an amazing report about the Taliban & these medications quotes in his article in the Seattle Times the Taliban psychiatrist who said taking these antidepressant drugs is like “swallowing a little piece of God” – the question would be whose God is that??? Yes it has become the new sacrament for far too many religions! He went on to talk about a leader in his army who continually put himself on the frontline of each battle because he became so suicidal. So this is clearly a worldwide problem.

Andrew’s father, Stan White, is doing much to gather all of the American families together who have lost sons to these drugs whether it be a sudden death as was Andrew’s or a suicide or a murder/suicide. Please refer anyone with a military background to Stan so that he can document these cases. The tragic suicide we posted a few days ago of Tony Orban would be yet another. Tony was a decorated soldier who served well & had only been with the police department for five years before he had his reaction to Zoloft after being prescribed the drug for PTSD from his service in the military. These cases are everywhere! Notice how often it is a vet involved in one of these antidepressant-induced crimes.

As you read through Kelly’s article keep in mind the death of Anna Nicole Smith’s young son Daniel as he slept in a chair at a Florida hospital while visiting his mother & new baby sister. Daniel was only 20, young & healthy, but on a combination of antidepressants & other serotonergic medications. I was interviewed with & worked with the famous forensic pathologist, Dr. Cyril Wecht, on Daniel’s case. In discussing the case it seemed quite clear to us that this was not just sudden cardiac failure, but very possibly multiple organ failure, the result of Serotonin Syndrome, produced by the combination of serotonergic medications he was taking. Such seems to be the case with these young men as well. Generally only two serotonergic medications given together can produce Serotonin Syndrome while these young men were given many serotonergic medications in combination.

To go to Kelly’s article click here: www.cchrint.org/2012/10/30/military-mental-health-treatment-becomes-frankenpharmacy/

One of my favorite parts of the article is Kelly’s assessment of the cozy ties & mentality in the military doing the “treating” of these young men:

“Matthew J. Friedman, the executive director of the Department of Veterans Affairs National Center for PTSD, and Professor of Psychiatry and Pharmacology at Dartmouth Medical School, was on the payroll of AstraZeneca, the maker of Seroquel. And, while a consultant to AstraZeneca, Friedman was one of four authors of the American Psychiatric Association’s 2009 Practice Guide for the Treatment of Patients with Acute Stress Disorder and PTSD.[1] Additionally, as a proponent of SSRI medications to treat PTSD, Friedman also sat on the PTSD Scientific Advisory Boards for GlaxoSmithKline and Pfizer—the makers of the antidepressants Paxil and Zoloft.[2]

“Despite Dr. Friedman’s belief that cocktails of mind-altering drugs will “help” those suffering from combat related symptoms, White’s symptoms not only persisted but worsened, and VA, military and civilian psychiatrists returned to their laboratories, ever convinced the next multi-drug elixir would elicit remarkable results.”

About the Author: Ann Blake Tracy is the author of PROZAC: PANACEA OR PANDORA?, and the director of the International Coalition For Drug Awareness [www.drugawareness.org]. She has testified before the FDA and has testified as an expert in legal cases involving serotonergic medications since 1992.

BOOK: Prozac: Panacea or Pandora? – Our Serotonin Nightmare! Anything you ever wanted to know about antidepressants is there along with everything drug companies hope you never find out about these drugs. SAFE WITHDRAWAL CD “Help! I Can’t Get Off My Antidepressant!” on how to safely withdraw from antidepressants & most psychiatric medications is saving lives! Both available at www.drugawareness.org

BOOK TESTIMONIALS:

“Very bold & informative”

“Priceless information that is giving me back to me”

“The absolute best reference for antidepressant drugs”

“Well documented & scientifically researched”

““I was stunned at the amount of research Ann Tracy has done on this subject. Few researchers go to as much trouble aggressively gathering information on the adverse reactions of Prozac, Zoloft and other SSRIs.”

WITHDRAWAL HELP CD TESTIMONIALS:

“Ann, I just wanted to let you know from the bottom of my heart how grateful I am God placed you in my life. I am now down to less than 2 mg on my Cymbalta and I have never felt better. I am finally getting my life back. I can feel again and colors have never been brighter. Thanks for all that you do!!” … Amber Weber

“Used your method of weaning off of SSRI’s and applied it to Ambien. Took 6 months but had been on 15 mg for years so what was another 6 months. I have been sleeping without it for 2 weeks and it is the first time I have been able to sleep drug free for 15 years. What a relief to be able to lay down and sleep when I need or want to. Ambien may be necessary for people at times but doctors giving a months worth of it at a time with unlimited refills is a prescription for disaster. It is so damn easy to become dependent on. Thanks for your council Ann.”… Mark Hill

“I’m so thankful for AnnTracy and all her work. Also for taking the time out to talk to me and educate everyone! She has been a blessing to me during this awful time of antidepressant hell!” … Antoinette Beck

 

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Efexor, Seroxat, Remeron

Efexor, Seroxat, Remeron,
octavia
In case of a mild depression, after a surgery operation, I received antidepressants SSRI class. I started trembling, especially every time when I wanted to give up. My doctors thought that I stiil have depression and increased the dose. I was more nervous, with muscle pain, chills, bladder problems, huge weight gain and muscle trembling. After 10 year, I gave up taking antidepressants.
Aftre 8 months i do not have chills , bladder problems but still muscle trembling. Anyone can advice me. It seems that only Lyrica helps a little bit. Every time when I use vitamins, omega 3 fish oil, 5 htp, I tremor more intensivly.

592 total views, 2 views today

Kauffman Study – (SSRI) Drugs: More Risks Than Benefits?

Journal of American Physicians and Surgeons Volume 14 Number 1 Spring 2009

SSRI Bombshell by Joel M. Kauffman, Ph.D. Tuesday, March 31st, 2009

Selective Serotonin Reuptake Inhibitor (SSRI) Drugs: More Risks Than Benefits?

Joel M. Kauffman, Ph.D.

ABSTRACT

Anecdotal reports have suggested that selective serotonin reuptake inhibitors (SSRIs) may cause suicidal or violent behavior in some patients. Because of the publicity surrounding certain events, and the numerous lawsuits that have been filed, a review of benefits and risks is needed.

At most 30% of patients receive a benefit from SSRIs beyond the large placebo effect in certain mental conditions, especially depression, according to a recent meta-analysis of published trials. An equally recent meta-analysis of all SSRI trials submitted to the FDA showed a small benefit for the severely depressed patients only. Many early unpublished trials did not show any benefit. Adverse effects are common, occurring in up to 75% of subjects.

Severe adverse effects may be underreported.

Meta- analyses of controlled trials did not include any actual suicides or murders, but only suicidality, some finding, in 1991 and 2007, no evidence even of suicidality.

Other meta-analyses using many of the same trials found that suicidality doubled to 1 in 500 on SSRIs compared with placebo or non-SSRI antidepressants, but did not include any actual suicides or murders. The trial designs were devised by SSRI makers to prevent reports of suicides, by eliminating subjects with the slightest trace of suicidal tendencies. Retrospective studies by others showed actual suicides on SSRIs with a relative risk (RR) of 2–3 compared with non-SSRI antidepressants, with an increased incidence of 123/100,000. Lower doses than the smallest available ones were found to maintain benefits in a majority of patients while reducing risks.

table_03_zoloftbusted1

[PLEASE NOTE THAT THE SSRISTORIES DATABASE REFERRED TO BY DR. KAUFFMAN IN THIS STUDY IS NO LONGER POSTED AT THE URL LISTED ABOVE BUT HAS BEEN MOVED TO THE URL www.ssristories.NET ]

No causal connection between SSRIs and suicide and/or violence has been proved; neither has it been ruled out. Physicians need to be vigilant, and aware of legal precedents that may subject them to enhanced liability when prescribing these drugs. The Genesis of SSRIs Fluoxetine (Prozac in the U.S., see Table 1), introduced in 1988 to combat depression, was the fourth selective serotonin reuptake inhibitor (SSRI) on the U.S. market, after being seriously considered by Eli Lilly as an antihypertensive drug. Unlike the earlier “tricyclics” (amitripyline, clomipramine, dothiepin, imipramine, etc.) and other drug classes, SSRIs acted on the brain to raise levels of the neurotransmitter serotonin without raising the levels of norepinephrine. This was thought to be a benefit in treatment of depression, and later anxiety, panic, social phobia, obsessive- compulsive disorder (OCD) , and many other conditions. The SSRIs listed in Table 1 are among the most frequently prescribed in the U.S., and compete with the five non- SSRIs shown, and others.

ssri-drug-table1

Benefits of SSRIs

A prominent recent meta-analysis of Bridge et al. included 27 trials of SSRIs for three defined mental conditions: major depressive disorder (MDD), OCD, and non-OCD anxiety disorders. Benefits, compared with placebo, were found to be highly statistically significant. For MDD, data from 13 trials showed benefit in 61% vs. 50% on placebo, a gain of 11% absolute (NNT=10), <0.001 for all ages of participants. For OCD, data from six trials showed benefit in 52% vs. 32% on placebo, a gain of 20% absolute (NNT=5), <0.001 for all ages. For non-OCD anxiety, data from 6 trials showed benefit in 69% vs. 39% on placebo, a gain of 30% absolute (NNT=3), <0.001 for all ages. These results represent the maximum expectation of benefit from SSRIs since 22 of the 27 trials were financially supported by SSRI makers, and thus subject to the routinely positive bias of industry-sponsored clinical trials. Jay S. Cohen, M.D., author of the 2001 book , wrote that half his patients did well on fluoxetine, but he noted a high incidence (50%) with side-effects. Cohen also cited a pre-approval study showing that the standard 20 mg per day starting dose helped 65% of patients, while 5 mg helped 54%, so Cohen became one of the pioneers in using lower doses before Lilly made them available. The 1996 entry for paroxetine, at least, confirmed that the 17 most common side-effects were dose-dependent.

In four observational cohort studies of four common SSRIs reported by physicians as part of the prescription-event monitoring program in the UK, with more than 10,000 patients in each drug group, only 36% of the physicians reported fluvoxamine as effective, compared with 60% for fluoxetine, sertraline, and paroxetine. These possible benefit rates, which include the placebo effect, parallel the percentage of patients remaining on the drug for 2 months.

See: Over Dose: the Case Against the Drug Companies

An old trial of placebo for anxious and depressed subjects reduced distress in 43%. Three meta-analyses of the antidepressant literature that appeared in the 1990s independently concluded that two-thirds of the effectiveness attributed to SSRIs is actually placebo effect. In a series of nine controlled studies on hospitalized patients with depression, 57% of those given placebo showed improvement in 2–6 weeks. A 1998 meta-analysis of 47 trials on antidepressant medication including SSRIs indicated that 75% of the response to them was duplicated by placebo. This meta-analysis was criticized on several grounds. Therefore, Irving Kirsch, Ph.D., of the University of Connecticut, with other authors, obtained data submitted to the FDA on every placebo-controlled clinical trial on the six most widely used SSRIs, and published a meta-analysis on 47 trials, finding a small, clinically insignificant effect.

This work was updated in 2008:

Analyses of datasets including unpublished as well as published clinical trials reveal smaller effects that fall well below recommended criteria for clinical effectiveness. Specifically, a meta-analysis of clinical trial data submitted to the U.S. Food and Drug Administration (FDA) revealed a mean drug–placebo difference in improvement scores of 1.80 points on the Hamilton Rating Scale of Depression (HRSD), whereas the National Institute for Clinical Excellence (NICE) used a drug–placebo difference of three points as a criterion for clinical significance when establishing guidelines for the treatment of depression in the United Kingdom. Kirsch et al. concluded that the updated findings from 35 carefully vetted trials suggest that, compared with placebo, the four new- generation antidepressants ( fluoxetine, venlfaxine, nefazodone, and paroxetine) do not produce clinically significant improvements in depression in patients who initially have moderate or even severe depression.

They show statistically significant but clinically minor effects only in the most severely depressed patients. Moreover, the significance of the effect probably is based on a decreased responsiveness to placebo, rather than increased responsiveness to medication. Given these results, the researchers conclude that there is little reason to prescribe new- generation antidepressant medications to any but the most severely depressed patients unless alternative treatments have been ineffective. In addition, they write that the decreased placebo response in extremely depressed patients, combined with a response to antidepressants comparable to that of less severely depressed patients, is a potentially important insight that should be investigated further.

Even these unimpressive findings exaggerated the benefits of antidepressants. In three fluoxetine trials and in the three sertraline trials for which data were reported, the protocol allowed replacement of patients who, in the investigators’ judgment, were not improving after 2 weeks. The trials also included a 1–2 week washout period, during which patients were given a placebo prior to randomization. Those whose scores improved 20% or more were excluded from the study. In 25 trials, the use of other psychoactive medication was reported. In most trials, a chloral hydrate sedative was permitted in doses ranging from 500 mg to 2,000 mg per day. Other psychoactive medication was usually prohibited but still reported as having been taken in several trials.

Perhaps such considerations led David Healy, M.D., an SSRI expert, to his conclusion that “…these drugs do not convincingly work….” His evidence came from early unpublished clinical trials whose results were revealed to him at FDA hearings. For fluoxetine, Healy noted four trials with a positive result and four without. For sertraline, only one of five early studies showed benefit. Because of the huge placebo effect, 32–75%, most physicians unfamiliar with the studies revealing this effect are likely, in my opinion, to say that one-third to two-thirds of their patients are improved on SSRIs. This would also explain Dr. Jay S. Cohen’s findings on lower doses of fluoxetine.

SSRIs reportedly interact with 40 other drugs to cause “serotonin syndrome.”

This presents as twitching, tremors, rigidity, fever, confusion, or agitation. Serotonin/norepinephrine reuptake inhibitors (SNRIs) also may cause serotonin syndrome by interactions. Most tricyclic depressants do not have these interactions, with the exception of amitriptyline.

In a controlled trial of paroxetine vs. clomipramine sponsored by GlaxoSmithKline, 75% of the subjects had an adverse effect on paroxetine, 21% had a severe adverse effect, and 13% committed a suicidal act (1 in 8). The 1996 entry for paroxetine lists 17 side-effects with an incidence of ≥ 5% for approved doses.

They are: asthenia, sweating, constipation, decreased appetite, diarrhea (up to 15%), dry mouth (up to 21%), nausea (up to 36%), anxiety, dizziness, nervousness, paresthesia, somnolence (up to 22%), tremor (up to 15%), blurred vision, abnormal ejaculation, impotence, and other male genital disorders. Fully 31 additional side effects with an incidence at least 1% greater than placebo were listed, including uncontrollable yawning.

Murder, suicide, and suicidality were NOT [emphasis added] included.

Nor were they on comparable lists for fluvoxamine, or sertraline. For fluvoxamine, suicide were separately listed as “infrequent.”

For fluoxetine, suicidal ideation was listed as a voluntary report not proved to be drug related. For sertraline, suicidal ideation and attempt were listed separately as “infrequent.”

The entry for venlafaxine was: “…the possibility of a suicide attempt is inherent in depression.” Not found in the was weight gain, which Cohen lists as a serious side effect.

Typical dropout rates in recent trials are claimed to be 5% (see below), but these must be short trials, or trials with a run-in period. In a meta-analysis of 62 earlier trials with a total of 6,000 subjects, the mean total dropout rate and the proportion of dropouts due to side effects appear comparable to results in general practice: total dropout rates of between 30% and 70% have been reported by 6 weeks, of which some 30%–40% are attributed to side effects and the rest to failure of treatment. Early findings of severe adverse effects by SSRI makers came to light only after the class was established. Of 53 healthy volunteer studies on fluoxetine, the results of only 12 were openly reported.

From 35 healthy volunteer studies on paroxetine, pre-launch, the results of only 14 appeared. From 35 pre-launch healthy volunteer studies on sertraline, only seven appeared. Among the unpublished trials, there was one in which all volunteers dropped out because of agitation (akathisia). In published work on sertraline, data excluded material on behavioral toxicity, including at least one suicide of a Adverse Effects of healthy volunteer, and in a different trial, 2 of 20 volunteers became intensely suicidal. This last is consistent with the dropout rate of 5% for agitation alone in actual trials. It is also consistent with Lilly’s animal studies, in which previously friendly cats treated with fluoxetine started growling and hissing—an unheeded warning.

Just a year after fluoxetine was introduced, Bill Forsyth of Maui, Hawaii, had taken it for only 12 days when he committed one of the first murder/suicides attributed to any SSRI.

In the same year Joseph Wesbecker killed eight others and himself in a Louisville, Ky., printing plant where he worked, after 4 weeks on fluoxetine. Yet as early as 1986, clinical trials showed a rate of 12.5 suicides per 1,000 subjects on fluoxetine vs. 3.8 on older non-SSRIs vs. 2.5 on placebo! An internal 1985 Lilly document found even worse results and said that benefits were less than risks. Such documents were released into the public domain by Lilly as part of the settlement in the Wesbecker case. Fifteen more “anecdotes” of murder/suicide, three with sertraline, were listed by DeGrandpre.

Lilly’s denials of a link to murder/suicide on national television and elsewhere cited a sponsored meta-analysis in in 1991, which exonerated fluoxetine as a cause of suicidal acts or thoughts without even mentioning actual murder or suicide. This study included only 3,067 patients of the 26,000 in the clinical trials it utilized. None of the trials had a declared endpoint of suicidality.

Some of the trials had been rejected by the FDA. No mention was made that Lilly had had benzodiazepines co-prescribed to minimizethe agitation that had been recognized with fluoxetine alone. The 5% dropout rate for anxiety and agitation (akathisia) would have taken out the most likely candidates for suicide. Nevertheless, the 1991 study had its intended effect. For example, in 2006 a 900-page tome entitled , which was aimed at attorneys, cited this study, and failed lawsuits concerning SSRIs. The 2007 meta-analysis by Bridge et al. may be influenced by indirect conflicts of interest that are hard to prove based on the financial disclosures.

Their paper pooled excess risk above placebo for “suicidal ideation/suicide attempt” from 27 trials. The excess risk was said to be 0.7% and statistically significant across all indications, but significant within each indication. Of the 27 trials, only five were sponsored by the drug maker, and one of these, the 2004 Treatment for Adolescents with Depression (TADS) study of fluoxetine, had the highest rate of suicidality—7% above placebo. Most of the same trials were used in a meta-analysis by the FDA, which found a statistically significant excess risk of 2% (4% vs. 2% on placebo, 1 in 50 more). Bridge et al. used a random-effects calculation, while the FDA used a fixed-effects calculation.

In commenting on the negative findings, Bridge et al. write: “No study [in our meta-analysis] was designed to examine suicidal ideation/suicide attempt as a study outcome, and in fact most trials were conducted in patients who had been carefully screened to exclude youths at risk.” No actual murders or suicides associated with SSRI use were reported. Did the designs of the studies preclude detection or reporting?

The Bridge meta-analysis was not just a vindication of SSRIs, as communicated to the by Gilbert Ross, M.D., Medical Director of the American Council on Science & Health. Ross went further, commenting that the FDA “Black Box warning” (see below) was counterproductive because it was discouraging the use of antidepressants! Ross speculated that the lethal rampage of the Virginia Tech shooter might have resulted from premature cessation of medications.

SSRIs in general have long lifetimes in the body. Fluoxetine and its active metabolite in particular have a half-life of 16 days, according to the 1996 . In a reexamination of trials in which suicides or attempts during the inadequate washout period were not blamed on the drug, it was shown that the relative risk (RR) of suicidal acts ranged from 3 for sertraline to 10 for fluoxetine.

A concurrent meta-analysis of 24 trials by Kaizar et al. utilized Bayesian statistics, a valid choice, in my opinion, because data do not have to follow a Gaussian or normal curve to yield valid results, and this method can be used to revise probabilities to determine whether a specific effect was due to a specific cause. They found an association between SSRI use and suicidality with odds ratios of 2.3 (95% confidence interval [CI] 1.3-3.8), when the diagnosis was MDD, not OCD, anxiety, nor ADHD. Non-SSRI antidepressants were said to have no association with suicide. This supports the FDA’s findings and requirement, as of October, 2004, for a Black Box warning for all SSRIs, to monitor children and adolescents for suicidality. Kaizar et al. were concerned that there were no completed suicides among 4,487 subjects in the trials; that the trial times were too short at median length of 8 weeks; and that in 10 of the 12 MDD studies, Again, there was no citation of actual suicides associated with SSRIs and no citation of Healy’s work.

Healy reviewed epidemiologic studies that have been cited to exonerate SSRIs. One was analyzed by Healy to show a threefold increase in suicidality compared with other antidepressants.While “treatment-related activation” has been considered primarily with regard to suicidality, it can lead to harm to others as well as to self. Healy summarized data on “hostile episodes” provided by GlaxoSmithKline from placebo-controlled trials with paroxetine in subjects of all ages: 9,219 on paroxetine and 6,455 on placebo. The rubric of “hostility” was used in the trial to code for aggression and violence, including homicide, homicidal acts, and homicidal ideation, as well as aggressive events and “conduct disorders.” No homicides were reported from these trials.

Overall, during both therapy and withdrawal, the RR was 2.1 for hostile events. In children with OCD the RR was 17. Separately, in healthy volunteer studies, hostile events occurred in 3 of 271 subjects on paroxetine vs. none of 138 on placebo. In trials of sertraline on depressed children submitted by Pfizer, 8 of 189 subjects discontinued for aggression, agitation, or hyperkinesis (a coding term for akathisia), compared with 0 of 184 on placebo. In clinical practice, the term akathisia has been restricted to demonstrable motor restlessness, but if that is the only effect, it would have been called dyskinesia according to Healy, who cites four studies linking akathisia to both suicide and homicide.

Actual suicides were combined with suicide attempts in a 2005 meta-analysis of 702 trials of SSRIs vs. either placebo or an active non-SSRI control. Studies were rejected if the citation was a review, a result of duplicate publication, too short, crossover, or had no reporting of actual or attempted suicide. The studies meeting the criteria included 88,000 patients. For attempted suicide, the RR was 2.3 for SSRIs vs. placebo (95% CI, 1.14-4.55). The number needed to treat to harm (sometimes called the “reverse NNT”) was 1 in 684. There was no difference in actual suicide. Of the 702 trials, 104 failed to report adverse events below a certain pre-set limit of 3%, 5%, or 10% of patients. Only 493 trials reported dropout rates, with a mean of 29%, and the mean follow-up time was only 11 weeks. Thus, there was clearly gross underreporting of adverse effects. PDR children and adolescents with an elevated baseline risk of suicide were excluded.

Journal of American Physicians and Surgeons Volume 14 Number 1 Spring 2009 9

More importantly, because actual suicides are involved, Healy cited a study by Donovan et al. that demonstrated a RR=3.4 ( <0.01) for SSRIs compared with all non-SSRI antidepressants involving 222 actual suicides, of which 41 were among patients who had an SSRI within a month of their suicide. Also the British Drug Safety Research Unit recorded more than 110 suicides in 50,000 patients taking an SSRI, an incidence of 219/100,000 compared with 96/100,000 for the non-SSRI mirtazepine (Remeron), an increase of 123/100,000, or 1 in 813 (Table 2). Thus the RR for actual suicide in patients taking SSRIs was 2.3 (or 2.8 for paroxetine). Even here, though, no murders were listed.

In another study cited by Healy, Jick et al. reported 143 actual suicides among 172,598 patients taking antidepressants. The relative risk of suicide in patients taking fluoxetine was 2.1, compared with those taking the tricyclic antidepressant dothiepin. The risk was not age-dependent. SSRI makers keep insisting that there will be more suicides if SSRIs are used as frequently as now. But the RR of 2–3 shown in studies is a number that the number of suicides that may have been prevented, so SSRI use is associated with more suicides, not fewer.

The International Coalition for Drug Awareness in cooperation with the Prozac Survivors Support Group has produced a website on which about 1,600 violent incidents associated with SSRI use are described ( www.ssristories.net ). The first column on the type of incident (murder, school shooting, etc.) is a hot link to a publicly available description of the incident, typically a local newspaper article. A selection of 10 entries (rows) is presented here as Table 3. About 360 suicides are tallied as well as about 400 murder incidents, many of which were multiple murders, each linked to 26 not net includesSSRIs Provide 1,600 Anecdotes of Violence SSRI use (Rosie Meysenburg, personal communication, 2008 .

As the number of “anecdotes” exceeds 1,600—hardly a small number—the association of SSRIs with murder/suicide, often combined, must be taken seriously. The SSRI website was searched to find combined murder/suicide incidents attributed to a specific SSRI. There were three for fluvoxamine, four for citalopram, 10 each for paroxetine and sertraline, and 31 for fluoxetine. Where the studies above substantiated suicide from SSRI use, the total on the SSRI website of 48 simultaneous murder/suicide incidents associated with SSRI use ties together SSRIs and murder. Since there were about two murders per suicide, we may infer that the murder rate on SSRIs could be about 250/100,000. Since no clinical trial involving multiple homicides is ever likely to be run, no firmer evidence is likely to be found. Healy noted that much of the evidence for suicide and murder came from the efforts of journalists and lawyers.
Note that the website carries a prominent warning that “withdrawal can often be more dangerous than continuing on a medication.” Nine violent events cited elsewhere—seven court cases of homicide (one attempted) and two assaults—were associated with specific SSRIs: three with paroxetine, three with sertraline, two with fluoxetine, and one with venlafaxine. Skeptics have cast doubt on whether the prescribed SSRIs were actually taken, especially since many medical records of juveniles were sealed. In the Columbine, Colo., shootings the toxicology report showed “therapeutic” levels of fluvoxamine in one of the shooters. The Red Lake, Minn., shooter had fluoxetine found, according to news items referenced on the website.

A 2004 editorial in by Simon Wessely, M.D., a spokes- man for Eli Lilly, and Robert Kerwin, Ph.D, cited only a single paper by Healy as a source of claims of suicidality that have found a receptive media audience. Tellingly, the only study described at length is by Jick et al. on the correlation of SSRI use and “attempted suicide,” in which the rates on dothiepin, amitriptyline, fluoxetine and paroxetine were not statistically different. Actual suicides in this study (seven on SSRIs) were not mentioned by Wessely and Kerwin, nor were the 143 suicides in Jick’s earlier paper. Jick et al. have been supported partially by GlaxoSmithKline and Pfizer. No study that reported actual suicides on SSRIs was described in detail, let alone refuted. Wessely and Kerwin wrote: “The problem is that depression is unequivocally and substantially associated with suicide and self-harm.” True, but this not the truth.

Table 2. Suicides Related to SSRIs or Mirtazapine

table_02_zoloftbusted1

The legal defense by Lilly, repeated by the media and others, is that any suicides are caused by the condition, depression, not by their drug—whether the violence is associated with short-term drug use, long-term drug use, increased doses, withdrawal, or rechallenge. There is no website, as far as I know, for violent acts committed by persons who never received SSRIs, or for total violent acts; hence the denominator for violent acts is not known. Also unknown is the fraction of potentially violent persons who are treated with SSRIs, or of persons treated with SSRIs who are potentially violent. The published studies on actual suicide, however, compare patients on SSRIs with similar patients on non- SSRI antidepressants or placebo. Children diagnosed with OCD, not depression, also became suicidal on SSRIs, as did healthy volunteers.

Actual two- to threefold increases in suicide rates have been demonstrated as well as they could be. How else could such effects be demonstrated? Who would submit, and what institutional review board or human subjects committee would approve a study explicitly designed to show whether assaultive, homicidal, or other violent behavior increases in subjects prescribed the study drug?

Denial by SSRI makers of culpability for these risks continues to this day. Whether physicians’ acting on the Black Box warnings of 2004 and 2007 for all SSRIs will diminish the incidence of murders and suicides is not yet known. Following the introduction of fluoxetine in 1988, only a year passed before an early user committed multiple murders and suicide; many other examples followed. More than 200 lawsuits have been begun by users of SSRIs and victims’ families charging wrongful death or failure to warn; these have had mixed outcomes. There is now legal precedent for SSRIs as a cause of murder, and the maker of the SSRI is potentially liable for damages, according to David Healy.

Eli Lilly responded with total denial to the lawsuits claiming a link between fluoxetine and violence. Several claims were settled out of court with secret details and no admission of guilt. The Australian David Hawkins was freed from a murder charge by a finding of temporary insanity caused by using sertraline. Tim Tobin of Wyoming won $6.4 million from SmithKline Beecham when a jury found that a murder/suicide committed by Donald Schell was attributable to use of paroxetine. There are four other homicide cases in which the SSRI was deemed to have contributed, resulting in a suspended sentence in one case and an insanity verdict in another.

One case of homicide, with a guilty verdict and a life sentence, followed a judicial ruling that akathisia was associated with SSRI use, but that a causal relationship with homicide could not be argued; thus the link of an SSRI with homicide was disallowed. This was in direct conflict with the findings of the four trials cited above. The SSRI website was searched to find murders related to a specific SSRI whose perpetrators were acquitted based on temporary SSRI-induced insanity. There were two cases with sertraline, four cases with paroxetine, and four cases with fluoxetine. So a precedent has been established for legal recognition that an SSRI can be a cause for murder, and that the drug maker can be found liable for damages. The notices of suicidality for the SSRIs found in the PDR or package inserts before 2004 did not really warn of actual suicide or murder.

200 SSRI-related Lawsuits

The Black Box warning of 2004 about possible suicide in children under 18 years of age did not cover adults or murder at any age, so potential liability for the SSRI makers still exists. In 2007 the warning was extended to persons under age 25 years. David Healy was quoted as saying that the warning was overdue, and that the risk was not likely to disappear above age 25. This was shown by the trials from GlaxoSmithKline on paroxetine cited above.

Antidepressants are extraordinarily difficult to assess for risks or benefits in trials. At most, 11%–30% of patients with depression or related conditions who take SSRIs actually benefited beyond the placebo effect on normal doses. Of the perceived benefit, 32%–67% can be attributed to the placebo effect. Adverse effects, mostly dose-dependent, will appear in up to 75% of patients on normal doses. Of these, studies suggest that suicidality will be observed in an additional 2%–13% (1 in 50 to 1 in 9) of patients on normal doses, beyond what is seen on placebo or many non-SSRI antidepressant drugs. This is sufficiently frequent that a typical prescribing physician should observe examples in routine practice.

The actual suicide rate could be about 123/100,000 (1 in 813) higher in patients on SSRIs than in those on tricyclics or placebo. Studies show that many more suicides are on normal doses of SSRIs beyond what is seen on placebo or many non-SSRI antidepressant drugs. Available data suggest that actual murders may be committed at about the rate of 250/100,000 (1 in 400) SSRI-treated patients beyond what is seen on placebo or many non-SSRI antidepressantdrugs, and that many more murders will be attempted on normal doses as well. While correlation does not prove causation, and results of court trials are not medical science, the data for suicide are solid, and the association of murder with suicide is very suggestive. Now that there is a stronger Black Box warning, physicians who ignore it may be liable for damages; the warning primarily protects the manufacturers of SSRIs. There is obviously great peril in drawing conclusions about causat i on from press report s or court decisions.

While manufacturers have a vested interest in exonerating their drugs, plaintiffs have an interest in blaming it, and defendants in exonerating themselves. We need careful, independent analysis of existing study data. In addition to randomized controlled trials, evidence from basic science ( neuropharmacology) and challenge/dechallenge/rechallenge investigations needs to be sought. Both the public and individual patients are imperiled by an incorrect answer to the pressing questions about these widely prescribed drugs. Future studies may show lower levels of murder and suicide with close supervision, and with better matching of this drug type to patient type.

Conclusionsattemptedsimultaneous
Joel M. Kauffman, Ph.D.

Acknowledgements:
Joel M. Kauffman, Ph.D., professor of chemistry emeritus at the
University of the Sciences, 600 S. 43rd St., Philadelphia, PA 19104-4495,
Contact: kauffman@bee.net.

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Frances E. H. Pane edited the manuscript. David Moncrief piqued my interest by providing a review copy of by Richard DeGrandpre.
The Cult of Pharmacology: How America Became the World’s Most Troubled Drug Culture

Journal of American Physicians and Surgeons Volume 14 Number 1 Spring 2009 11
Potential conflicts of interest: The author has neither a financial interest in any drug mentioned, nor in any alternate treatments for treating any mental illness.

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New York Times:Journal of American Physicians and Surgeons Volume 14 Number 1 Spring 2009

USA Trade Name Generic Name:
SSRIs
Celexa
Luvox
Paxil
Prozac
Zoloft
non-SSRIs
Effexor
Remeron
Serzone
Wellbutrin
(UK)
citalopram
fluvoxamine
paroxetine
fluoxetine
sertraline
venlafaxine
mirtazapine
nefazodone
bupropion
dothiepin USA Trade Name Generic Name
SSRIs
Celexa
Luvox
Paxil
Prozac
Zoloft
non-SSRIs
Effexor
Remeron
Serzone
Wellbutrin
(UK)
citalopram
fluvoxamine
paroxetine
fluoxetine
sertraline
venlafaxine
mirtazapine
nefazodone
bupropion
dothiepin

Physicians Desk Reference (PDR)
Joel M. Kauffman, Ph.D.
Table 1. Commonly Prescribed SSRIs and Other Antidepressants Selective Serotonin Reuptake Inhibitor (SSRI) Drugs:
More Risks Than Benefits?

Journal of American Physicians and Surgeons Volume 14 Number 1 Spring 2009 7 Physicians Desk Reference (PDR)
Joel M. Kauffman, Ph.D.
Table 1. Commonly Prescribed SSRIs and Other Antidepressants Selective Serotonin Reuptake Inhibitor (SSRI) Drugs:
More Risks Than Benefits?

Journal of American Physicians and Surgeons Volume 14 Number 1 Spring 2009 7

JAMAwhole12,69210,98313,74112,73450,15013,554

10 dead, 7 wounded: dosage increased one week before rampage
15 year old shoots two teachers, killing one: then kills himself
Columbine High School: 15 dead, 24 wounded
Four dead, twenty injured after Prozac withdrawal
Teen shoots at two students: kills his father
Jury finds Paxil was cause of murder-suicide
Man cleared of charges due to Paxil withdrawal defense
Not guilty by reason of Prozac induced insanity: mother kills daughter
Nine dead, 12 wounded in workplace shooting
11 year old hangs himself: lawsuit

Journal of American Physicians and Surgeons Volume 14 Number 1 Spring 2009

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Our Lives are Following Apart

“The doctor … just kept adding more (antidepressants).”

My name is Susan Sweatman, and my husband’s doctor had him on Paxil and three other antidepressants at the same time. He was on these awful drugs for 3 years. The doctor did not take him off of one and try another, he just kept adding more.

Paxil worked for a while then after he had problems sleeping, the doctor added Trazadone, Ambien and Remeron. He took these as prescribed by the doctor. He started drinking beer.

It got to where he was drinking a case of beer a night, always mad. Still could not sleep, then when he would sleep, he could not get up.

We found out last June our doctor was hooked on drugs and was sent to dry out. Then while he was gone, the other doctor without seeing my husband kept writing prescriptions for these drugs. Our doctor died in Feb.

Last October my husband got mad pulled a gun on me and our son, and said he was going to kill us. I called the police, and he was arrested. We did not know anything about these drugs, and that you are not supposed to be on them that long.

Now the court will not let us be together, and we have no hope. Someone told me about this website. We need help to get through this. He does not take any pills or drink now, but is still having problems with memory. He does not remember anything that he did that night. Please is there someone who can help us?

Thanks

Susan
Sweatmansds@aol.com

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