9/11-Paxil Birth Defect Case-One Year Anniversary of the Death of Baby Indiana

Why would it even be going to court? Glaxo is so stupid! They let the Donald Schell murder/suicide case go to court and look what it got them. Now they are going to do this????

Who is handling this one? Hope the attorneys are using Dr. Pal Paucher whose work has demonstrated this for a very long time.

-Ann

[NOTE: This is being sent to you directly as well as being posted on our “BREAKING NEWS” section of our new website. We are posting new cases there as they come in as well..]

We just had the anniversary of 9/11. And today is the anniversary of the death of baby Indiana. And this week we will have the first Paxil Birth Defect case hit the courts.

So what do all of these have in common? PLENTY!!

Baby Indiana lost her life a year ago today due to the fact that her mother took Effexor during her pregnancy and her parents were not warned of the potentially fatal dangers involved. (Please go to one of the sites below to lend support to her family in their battle to raise awareness and also to see what happened to baby Indy.)

All antidepressants increase serotonin levels. The main function of serotonin is constriction of smooth muscle tissue – the lungs and broncial tubes, the intestines, uterus, and the major organs of the body.

Serotonin was originally given to put pregnant women into labor so is it any wonder that Indy and so many other babies born to mothers on antidepressants are either miscarried or born early?

When serotonin levels go too high it results in Serotonin Syndrome which can be fatal producing death via multiple organ failure as the organs constrict and shut down as happened with baby Indy’s lungs.

Now the 9/11 connection: EVERY WEEK IN THIS COUNTRY WE LOSE AS MANY LIVES AS WE LOST IN THE 9/11 TRAGEDY TO ADVERSE REACTIONS FROM PRESCRIPTION DRUGS PRESCRIBED VIA FDA GUIDELINES – NOT ABUSED, BUT GIVEN AND TAKEN ACCORDING TO FDA GUIDELINES.

Why, are we at war in the Middle East over so few deaths (not that they did not matter or were any less important) as opposed to the thousands upon thousands of needless and senseless deaths that continue to happen every week in America due to these deadly prescription drugs that the world tends to ignore?!!! This is an ongoing, never ending 9/11 tragedy striking every week for years before 9/11 and for many years now since 9/11.

Who are the real terrorists? And why have we not declared war on them?

Now this week another family will go into court to fight the battle their little one cannot fight on his/her own. The birth defects have been known of for some time in medical science, but not shared with the parents of those who should be watching for them.

And just how many are there? We have NO idea. Most families are dealing with them with no idea even yet what the cause is. Last year I was speaking with a father about a business matter who explained he could not speak long because his 15 year old daughter was born with a hole in her heart and he had to run her to a doctor’s appointment.

I immediately asked which antidepressant his wife was taking during pregnancy with his daughter. Without hesitation he turned to his wife and asked, “Honey, which antidepressant were you on when you carried ________? Paxil. It was Paxil remember? That was when you had me start taking it.”

Of course I told him he needed to look up the FDA warnings on the drug and heart defects at birth due to the drug. I then gave him the numbers of several attorneys and explained that his daughter has every right to file for this terrible problem that has so affected her life for the past 15 years and will for the rest of her life that will be cut short as a result of the damage done by the drug.

So how many other 15 year olds are there out there dealing with these birth defects even though they have no knowledge of this being a side effect of their mother’s medication? And how many others like Indy did not survive their damages? We need to know. Hopefully this case finally making its way into court will stir up enough publicity to wake up enough people to give these children and their families answers.

Dr. Ann Blake-Tracy, Executive Director,
International Coalition for Drug Awareness
www.drugawareness.org & www.ssristories.drugawareness.org
Author of Prozac: Panacea or Pandora? – Our
Serotonin Nightmare (Order #)

http://wp.me/phViU-qd

Today, September 13, 2009 is the one year anniversary of Indiana Delahunty’s death. We encourage you to please go to her parent’s, Christian & Matt Delahunty’s, blog to offer some moral support to the family at this time.

http://indibaby.wordpress.com/

http://www.fiercepharma.com/story/test-paxil-case-hits-court-next-week/2009-09-11
Test Paxil case hits court next week
September 11, 2009 — 10:43am ET | By Tracy Staton
Related Stories

* AP: Glaxo reps aided Paxil ghostwriting
* Supremes ask for Obama view in vaccine case
* Glaxo under scrutiny in EU
* U.S. Paxil probe broadens
* Grassley asks FDA for Paxil review

GlaxoSmithKline and a bunch of plaintiffs’ lawyers will have their eyes on a Philadelphia court next week. That court is hosting a bellwether liability case over claims that the antidepressant Paxil causes birth defects. Glaxo faces some 600 lawsuits with similar claims. “These cases are sort of like the canary in the coal mine,” law professor David Logan told Bloomberg. “The early cases set the parameters for any global settlement negotiations.”

In this first case, plaintiff Michelle David claims that Paxil caused heart defects in her son Lyam Kilker and that Glaxo failed to warn about the drug’s potential to cause birth defects. As you know, FDA asked Glaxo in 2005 to update Paxil’s label with information on heart defects in infants. Glaxo says the FDA’s action doesn’t prove that Paxil causes birth defects; its own studies after the warning “have been inconclusive with mixed results,” the company says.

But David’s attorney says that Glaxo failed to follow up on early animal studies that suggested Paxil might cause birth defects, and that the company designed Paxil studies to use low doses of the drug to avoid triggering adverse events. “In 1998, GSK internally concluded that it had received an ‘alarming’ number of abnormal pregnancy adverse events for Paxil and failed to disclose this information to the FDA, physicians or the public,” the lawyers said in a court filing. We’ll be hearing much more from both sides next week.

– read the Bloomberg piece

Read more: http://www.fiercepharma.com/story/test-paxil-case-hits-court-next-week/2009-09-11#ixzz0Qq0vDCIS

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Leslie Judd’s Story – post-partum depression – Prozac, Paxil and Trazodone

Leslie Judd’s Story

My name is Leslie Judd and I appreciate the opportunity to tell you my story. I recently had a major life change which came about because of information that was passed on to me by Young Living Essential Oils.

Eleven years ago, I experienced some serious depression which I now recognize was most likely post-partum depression, since it began following the birth of my third child. The condition was serious enough to cause me to be unable to function normally. After a visit to the doctor, I came home with a prescription for Prozac, and this was the beginning of a ten-year nightmare.

Within the first few days, I began having hallucinations and hearing voices, but had no relief from the depression. At my next appointment, the doctor prescribed Paxil and Trazodone. Temporarily, it seemed to help with the depression, but I was a zombie all of the time. I felt like I had a hangover every morning.

With Paxil and all of the anti-depressants I took from then on, I had what is called a withdrawal or “wear-off” effect, which means that my body soon adjusted to the new dosage and then I would need a higher dosage. Symptoms of this effect were electrical sensations throughout my body, shudders and whoosh sound with every move. Also, a trailing feeling when I moved or turned my head. This increased until the doctor would change my medication and I would begin the cycle again. I began fluctuating between depression and hypomania.

The therapist I started seeing referred me to a psychiatrist, who put me on a fairly low dose of Zoloft. My initial diagnosis was Major Depressive Disorder, but soon became Dysthymia, or severe mood disorder. After trying different antidepressants, like Effexor, Serzone (now off the market due to the fact that it causes liver failure) and Wellbutrin, all of which gave only temporary relief, she decided to try lithium because my symptoms had become like that of a bipolar patient. So now the diagnosis had become Bipolar II Disorder.

Next, the doctor decided to experiment with different types of drugs such as anti-seizure medications (such as Topamax, Depakote, Lamictal and Neurotin) and anti-psychotics (such as Risperdal, Sroquel, and Zyprexa), which caused me to have a multitude of other side-effects such as tremors, visual disturbances, anxiety and nervous problems for which I was prescribed benzodiazepines. Guess what? I became even more depressed and I was more ill than I had ever been before in my life.

The inherent back problem I have had since I was a teenager was now getting worse. The medications decreased my pain tolerance. I developed fibromyalgia. I became obsessed with illness and with pain. I gained an excessive amount of weight. I also began behaving impulsively, lost interest in relationships and developed social phobias such as agoraphobia (fear of public places, not wanting to leave home). I would panic in crowds, break out in a sweat, and collapse in terror.

I could not feel joy or affection, and didn’t want anyone to touch me. I became obsessed with death. Sometimes, I cried uncontrollably without knowing why. I felt like I was a burden to everybody. I spoke with slurred speech, couldn’t find words and had loss of memory. The tremors became so severe that I could no longer write a check or sign my name. This only led to more anti-social behavior and self isolation.

Every month when I went to my doctor, my medication and dosage were changed. There was a point during the ten years that I realized the medication was making me sick, especially when I got lithium toxicity. My body was holding on to all fluid, I was bloated beyond recognition, my pupils were dilated (one more than the other), I started to get panicky and I had constant nausea and severe headaches along with other symptoms which alarmed my husband, and he called my doctor, who told me to stop taking the medication immediately.

This stopped the toxicity from progressing, but the immediate withdrawal caused me to crash into an even deeper depression. More medication, without relief. More suicidal ideation. Alcohol binges.

When I was released and came home, I was worse than ever. I was having hallucinations. I shook uncontrollably, which was actually a side effect of anti-seizure medications, and I had to move my legs constantly. My eyes were dead and I had absolutely no energy and no desire to do anything. I felt empty. My family rallied to get me back on my feet and friends brought dinner to help out. It was as if I was seeing things from outside of my body, but I actually remember very little from this time period.

An attempted suicide made for my second hospital stay, where I was humiliated in front of other patients by psychiatric techs, after which I made another attempt to end my life while I was still in the hospital. To get out of the hospital, I lied by telling them I felt better. Eight days later, I went home on new drugs.

After two weeks at home, I was back in the hospital for another eight days. I was so out of it. I felt like I was in a vacuum. I did things contrary to my nature, not even thinking of the consequences. Nothing mattered. On leaving the hospital following my third stay, I was told that my diagnosis was Bipolar II, Panic and Anxiety Disorder, PRSD (post-traumatic stress disorder), and Borderline Personality Disorder with psychotic episodes. It seemed that I would just get worse and never be well again.

Back home, my family searched for answers. Our good friends, Brian and Barb Kuckuck, went to a Young Living convention in California and returned with help — an audio tape and a book by Ann Blake-Tracy.

The tape opened our eyes to the destruction that these drugs can cause in people’s lives. Today, I know that I have a disposition towards depression, but I am not bipolar. I am not psychotic and I do not have a borderline personality disorder. My mental and physical disorders were caused primarily by the medication I was given by my doctors. I lost ten years of my life.

I followed Ann Blake-Tracy’s guidelines for tapering off of the medication and I have been using the Cortistop and other YL supplements as well as essential oils, particularly Valor, Clarity and Peace and Calming, without which I know it would have been much more difficult to break free from the drugs. The weaning process can last up to two years, but it is worth it.

Today, I have been completely free of my medications for five months. Although I still have some residual side effects, I am living my life again and enjoying it. I thank Young Living and Ann Blake-Tracy for making me aware, I thank my husband and children for their untiring love and patience, thanks to my family for their persistence and love in searching for something to help. I appreciate my friends, who were there for me even though I didn’t know it and I especially thank my faith for giving me the strength and courage to succeed.

For more information on the essential oils discussed here, see Ann Blake-Tracy’s book, Prozac, Panacea or Pandora? – Our Serotonin Nightmare and her tape or CD entitled, “Help! I Can’t Get Off My Antidepressant”. You can order these by calling 1-.

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Jenny McKinney – clinical depression – Paxil

My name is Jenny McKinney. I am 26 and a stay-at-home mother of three boys, ages 5, 4, and 1 year.

I was diagnosed with clinical depression in August of 1995. I was suicidal and depressed when I was prescribed the anti-depressant, Paxil. My mood swings were already out of control, but worsened after taking Paxil. I was told I would not see results for at least three weeks after beginning the drug. Within three days, my sister, whom was pregnant and I roomed with at the time, said if I did not get off the drug immediately, I was to find another place to live, because she would not have that baby with me in the home.

On Paxil, my mood swings increased greatly to the point I was sugar sweet one minute and violently psychotic the next. I was always nauseated, dizzy, and blacking out. To this day I cannot remember everything that went on at that time in my life. I was only on the drug for 2 weeks and quit cold turkey without consulting my psychiatrist.

I tried to handle life without any kind of meds, but over the next few years tried many herbals, including licorice root, St. John’s Wort, and SamE.

I struggled over the next few years with my depression and anxiety, as I married and had children. I tried counseling, different herbs, and much, much prayer. There were even a couple of times when the doctors wanted to institutionalize me. In spite of all my efforts, after having children the rage really set in. I was constantly yelling at my children, then 3
years and 18 months. I knew I was out of control with my depression and anger when my second son splashed in the bathtub and I spanked his bottom, several times, extremely hard, then sat and cried for hours over doing it. I was truly fearful that I would end up seriously hurting my kids if I did not get help.

Later in the week, my boys and I went to visit family out of state. My mother-in-law introduced me to Reliv when I arrived. As soon as she heard about it, she knew it was what I needed to get better. That was all I needed to hear. I began on Reliv Classic and Innergize immediately. I was taking them two times a day. By the third day, the same sister noticed the difference in me when I had not had my product. By the end of my two-week stay, I had not yelled at my children once.

I have since then had another child, and am able to handle life wonderfully, when I am consistent in taking these products. The best part, is knowing that as long as I am taking Reliv, my children are not afraid of me anymore.

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SSRI Antidepressant- Manie’s Story Paxil and birth defects

My son, Manie, was born with a rare heart defect because I took Paxil during my first three months of pregnancy. Manie had to have a hole ripped into his heart shortly after birth to save his life. At eight days old he had a 12hr. open heart surgery.

Manie is 5 yrs old now. He has a leaky valve which was caused by the open heart surgery. He has been on numerous medications. One of the medications he takes daily is for high blood pressure. He has been on this medication since he was one week old.

Manie has also suffered with severe acid reflux. This has cause extensive damage to his teeth and damage to his throat. Manie also experiences severe stomach cramps multiple times during the day and night. During the night he not only wakes from stomach cramps he often wakes screaming and crying because of arm and leg cramps.

When Manie was a year old it was discovered through a cardiac cath. he has collaterals (vessels) growing off of both sides of his heart. These collaterals attach to the arteries that go to his lungs. Manie has had to have several coils placed into the collaterals to plug them up. You can read more about Manie at www.bigpharmavictim.blogspot.com

Thank You,
Julie Edgington

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Paxil: Iraq War Vet Suicidal: Holds Police At Bay for 9 Hours: Michigan

Note from Ann Blake-Tracy: Yet another suicidal vet who first overdosed on his
antidepressant and Xanax and then became homicidal enough that he was going
to shoot police – often in an attempt to commit what is now called suicide
by cop. These drugs produce both suicide and violence as we see once again
in this case.
________________________________________________________________

First three sentences read: "A suicidal veteran who held Howell Police at
bay for more than nine hours Thursday night into early this morning is
hospitalized and undergoing psychiatric evaluation. Howell Police Chief George
Basar says that just before 6 oâ

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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.

REFERENCES
DeGrandpre R.,Durham, N.C.: Duke University Press; 2006.

The Cult of Pharmacology: How America Became the World’s Most Troubled Drug Culture.
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Jørgensen AW, Hilden J, Gøtzsche PC. Cochrane reviews compared
with industry supported meta-analyses and other meta-analyses of
the same drugs: systematic review. doi:10.1136/bmj.38973.
444699.0B (publ Oct 2006).

Cohen JS. New York, N.Y.: Tarcher/Putnam; 2001.

Mackay FJ, Dunn NR, Wilton LV, et al. A comparison of fluvoxamine, fluoxetine, sertraline and paroxetine examined by observational cohort studies. 1997;6:235-246.

Park L, Covi L. Nonblind placebo trial. 1965;336-345.

Cole JO. Therapeutic efficiency of antidepressant drugs: a review. 1964;190:124-131.

Kirsch I, Moore TJ, Scoboria A, et al. The emperor’s new drugs: an analysis of antidepressant medication data submitted to the U. S. Food and Drug Administration. 2002;5(1):23-33.

Kirsch I, Deacon BJ, Huedo-Medina TB, et al. Initial severity and antidepressant benefits: a meta-analysis of data submitted to the Food and Drug Administration. 2008;5(2):e45. doi:10.1371/journal.pmed.0050045.

Healy D. One flew over the conflict of interest nest. 2007;6(1):26-27.

Healy D. New York, N.Y.: New York University Press; 2004.

Healy D. FDA Psychopharmacologic Drugs Advisory Committee hearings. Available at:: www.healyprozac.com/PDAC. Accessed May 13, 2007.

Wolfe SM, ed. SSRIs can have dangerous interactions with other drugs. 2008;14(1):2-5. www.citizen.org/hrg/. Accessed Feb 4, 2009.

JAMA BMJ, Over Dose: The Case Against the Drug Companies.
Pharmacoepidemiol Drug Safety Arch Gen Psychiatry

JAMA
Prevention & Treatment
PLoS Medicine
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Let Them Eat Prozac: The Unhealthy Relationship Between the Pharmaceutical Industry and Depression.
Worst Pills Best Pills News

Braconnier A, Le Coent R, Cohen D. Paroxetine versus clomipramine in adolescents with severe major depression: a double-blind, randomized, multicenter trial. 2003;42:22-29.

Anderson IM, Tomenson BM. Treatment discontinuation with selective serotonin reuptake inhibitors compared with tricyclic antidepressants: a meta-analysis. 1995;310:1433-1438.

Healy D. Lines of evidence on the risks of suicide with selective serotonin reuptake inhibitors. 2003:72:71-79.

Healy D, Herxheimer A, Menkes DB. Antidepressants and violence: problems at the interface of medicine and law.
2006;3(9):1478-1487.

Beasley CM, Dornseif BE, Bosomworth JC. Fluoxetine and suicide: a meta-analysis of controlled trials of treatment for depression. 1991;303:685-692.

Cohen H. Antidepressants: clinical use and litigation. In: 2nd ed. O’Donnell JT, ed. Tucson, Ariz.: Lawyers & Judges Publ.Co; 2006:379-390.

Ross G. Black Box backfire. Apr 21, 2007.

Donovan S, Clayton A, Beeharry M, et al. Deliberate self-harm and antidepressant drugs. 2000;177:551-556.

Kai zar EE, Gr eenhouse JB, Sel t man H, Kel l eher K . Do antidepressants cause suicidality in children? A Bayesian meta-analysis. 2006;3:73-98.

Berenson ML, Levine DM.. 7th ed. Upper Saddle River, N.J.: Prentilee-Hall; 1998:213-217.

Healy D, Whitaker C. Antidepressants and suicide: risk-benefit conundrums. 2003;28:331-337.

Fergusson D, Doucette S, Glass KC, et al. Association between suicide attempts and selective serotonin reuptake inhibitors.2005;330:396-402.

Donovan S, Kelleher MJ, Lambourn J, Foster T. The occurrence of suicide following the prescription of antidepressant drugs.1999;5:181-192.

Jick SS, Dean AD, Jick H. Antidepressants and suicide.1995;310:215-218.

Wessely S, Kerwin R. Suicide risk and SSRIs. 2004;292:379-381.

Jick H, Kaye JA, Jick SS. Antidepressants and the risk of suicidal behaviors. 2004;292:338-343.

Carey B. FDA expands suicide warning on drugs. ,May 3, 2007:A17.

J Am Acad Child Psychiatry BMJPsychother PsychosomPLoS Med
BMJ

Drug Injury:Liability, Analysis and Prevention.

Wall Street Journal,Br J Psychiatry Clinical Trials

Basic Business Statistics: Concepts and Applications J Psychiatry Neuroscience

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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DEPRESSION MED: Woman Stabs To Death A Man On A Stairwell: Australia

Paragraph three reads:  “Defence solicitor Bernie Balmer said Epshtein was on medication for anxiety, bipolar, depression, pain and one to lower her heart rate.”

http://www.theage.com.au/national/woman-in-court-over-stabbing-murder-20090803-e6l0.html

Woman in court over stabbing murder

Steve Butcher

August 3, 2009 – 12:04PM

A 21-year-old woman charged with the stabbing murder last week of a man in a St Kilda stairwell has appeared in court.

A lawyer for Natasha Epshtein told Melbourne Magistrates Court today his client had been treated by two doctors for five separate health conditions.

Defence solicitor Bernie Balmer said Epshtein was on medication for anxiety, bipolar, depression, pain and one to lower her heart rate.

Epshtein appeared before Deputy Chief Magistrate Dan Muling in a low-cut, black t-shirt with close-cropped hair and tattoos on her upper chest.

She is charged with murdering Peter James Len on July 30.

Mr Balmer said she would consent to a DNA sample being taken at a later date.

She was remanded to appear again on November 30.

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DEPRESSION MED: Woman Assaults a Deputy Sheriff: Colorado

Paragraqphs two and three read:  “Tanya Eliz Moschetti, 42, 1253 12 1/2 Road, was arrested on suspicion of second-degree assault on a peace officer, third-degree assault and criminal mischief after deputies received a report of a possible overdose at her house and were told she was running around the house naked and breaking things, according to an arrest affidavit.”

“When deputies arrived, they noted Moschetti, who was standing outside and cursing at a man inside, was slurring her speech and had a distant gaze in her eyes. She said she was taking medication for depression.”

http://www.gjsentinel.com/hp/content/news/police/stories/2009/08/02/080309_3a_Blotter.html

Police blotter: August 3, 2009

Sunday, August 02, 2009

Assault suspect arrested

A Loma woman was arrested Saturday after she allegedly assaulted a sheriff’s deputy who had responded to a domestic disturbance at her house, the Mesa County Sheriff’s Department said.

Tanya Eliz Moschetti, 42, 1253 12 1/2 Road, was arrested on suspicion of second-degree assault on a peace officer, third-degree assault and criminal mischief after deputies received a report of a possible overdose at her house and were told she was running around the house naked and breaking things, according to an arrest affidavit.

When deputies arrived, they noted Moschetti, who was standing outside and cursing at a man inside, was slurring her speech and had a distant gaze in her eyes. She said she was taking medication for depression.

At one point, Moschetti tried to re-enter the house and struck a deputy on the arm when he tried to stop her.

Deputies arrested Moschetti and booked her into Mesa County Jail.

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Antidepressant use doubles in U.S., study finds

“Not only are more U.S. residents being treated with antidepressants, but also those who are being treated are receiving more antidepressant prescriptions,” they added.
[Note by Ann Blake-Tracy: Far too many doctors are prescribing two and even three antidepressants at a time which should never be done due to the high potential of resulting Serotonin Syndrome from the combination.]
“During this period, individuals treated with antidepressants became more likely to also receive treatment with antipsychotic medications . . . “
[Note by Ann Blake-Tracy: Additional supporting data to add to the story we just sent out on 81% of those diagnosed with Bipolar Disorder having been previously treated with antidepressants or Ritalin type drugs – making these popular drugs the main triggers for Bipolar Disorder and manic psychosis.]

Antidepressant use doubles in U.S., study finds

1 in 10 are taking medication to improve mood, fewer going to talk therapy

By Maggie Fox

updated 2:44 p.m. CT, Mon., Aug 3, 2009

WASHINGTON – Use of antidepressant drugs in the United States doubled between 1996 and 2005, probably because of a mix of factors, researchers reported on Monday.

About 6 percent of people were prescribed an antidepressant in 1996 — 13 million people. This rose to more than 10 percent or 27 million people by 2005, the researchers found.

“Significant increases in antidepressant use were evident across all sociodemographic groups examined, except African Americans,” Dr. Mark Olfson of Columbia University in New York and Steven Marcus of the University of Pennsylvania in Philadelphia wrote in the Archives of General Psychiatry.

“Not only are more U.S. residents being treated with antidepressants, but also those who are being treated are receiving more antidepressant prescriptions,” they added.

More than 164 million prescriptions were written in 2008 for antidepressants, totaling $9.6 billion in U.S. sales, according to IMS Health.

Drugs that affect the brain chemical serotonin like GlaxoSmithKline’s Paxil, known generically as paroxetine, and Eli Lilly and Co’s Prozac, known generically as fluoxetine, are the most commonly prescribed class of antidepressant. But the study found the effect in all classes of the drugs.

Olfson and Marcus looked at the Medical Expenditure Panel Surveys done by the U.S. Agency for Healthcare Research and Quality, involving more than 50,000 people in 1996 and 2005.

“During this period, individuals treated with antidepressants became more likely to also receive treatment with antipsychotic medications and less likely to undergo psychotherapy,” they wrote.

Newer drugs, more social acceptance
The survey did not look at why, but the researchers made some educated guesses. It may be more socially acceptable to be diagnosed with and treated for depression, they said. The availability of new drugs may also have been a factor.

“Although there was little change in total promotional spending for antidepressants between 1999 ($0.98 billion) and 2005 ($1.02 billion), there was a marked increase in the percentage of this spending that was devoted to direct-to consumer advertising, from 3.3 percent ($32 million) to 12 percent ($122.00 million),” they added.

Dr. Eric Caine of the University of Rochester in New York said he was concerned by the findings. “Antidepressants are only moderately effective on population level,” he said in a telephone interview.

Cost may be deterrent to talk therapy
Caine, who was not involved in the research, noted that several studies show therapy is as effective as, if not more effective than, drug use alone.

“There are no data to say that the population is healthier. Indeed, the suicide rate in the middle years of life has been climbing,” he said.

Olfson and Marcus said out-of-pocket costs for psychotherapy and lower insurance coverage for such visits may have driven patients away from seeing therapists in favor of an easy-to-prescribe pill.

The rise in antidepressant prescriptions also is seen despite a series of public health warnings on use of antidepressant drugs beginning in 2003 after clinical trials showed they increased the risk of suicidal thoughts and behaviors in children and teens.

In February 2005, the U.S. Food and Drug Administration added its strongest warning, a so-called black box, on the use of all antidepressants in children and teens.

Copyright 2009 Reuters. Click for restrictions.

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ICFDA Warning on Drug Discontinuation

Taper off very, very, very slowly!!!!!!!!!!!!!!

Dropping “cold turkey” off any medication, most especially mind altering medications, can often be MORE DANGEROUS than staying on the drugs. With antidepressants the FDA has now warned that any abrupt change in dose, whether increasing or decreasing the dose, can produce suicide, hostility, or psychosis – generally a manic psychosis when you then get your diagnosis for Bipolar Disorder. Of course drug-induced Bipolar is temporary so you need to learn more about that if it has already happened to you. We have a DVD on explaining this and how to recover from it: “Bipolar? Are You Really Bipolar or Misdiagnosed Due to the Use of or Abrupt Discontinuation of an Antidepressant”: https://store.drugawareness.org/product/bipolar-disorder-streaming/

The most dangerous and yet the most common mistake someone coming off any antidepressant, atypical antipsychotic, or benzodiazaphine makes is coming off these drugs too rapidly. Tapering off VERY, VERY, VERY SLOWLY–OVER MONTHS OR YEARS (The general rule of thumb for those on antidepressants (ANY antidepressant, not just the current antidepressant – add up all time on any of them) for less than a year is to take half the amount of time on them to wean off and for long-term users for each 5 years on psychiatric drugs of any kind  the general rule of thumb is at least a year or more.), NOT JUST WEEKS OR MONTHS!—has proven the safest and most effective method of withdrawal from these types of medications. Thus the body is given the time it needs to readjust its own chemical levels. Patients must be warned to come very slowly off these drugs by shaving minuscule amounts off their pills each day, as opposed to cutting them.

WARNING: The practice of taking a pill every other day throws you into withdrawal every other day and can be very dangerous when you consider the FDA warnings on abrupt changes in dose.

This cannot be stressed strongly enough! This information on EXTREMELY gradual withdrawal is the most critical piece of information that someone facing withdrawal from these drugs needs to have.

A REMINDER: IT IS EASIER TO GET DOWN OFF A MOUNTAINTOP ONE GUARDED STEP AT A TIME THAN TO JUMP FROM THE TOP TO THE BOTTOM.

No matter how few or how many side effects you have had on these antidepressants, withdrawal is a whole new world. The worst part of rapid withdrawal can be delayed for several months AFTER you quit. So even if you think you are doing okay you quickly find that it becomes much worse. If you do not come off correctly and rebuild your body as you do, you risk:

  • Creating bouts of overwhelming depression
  • Producing a MUCH longer withdrawal and recovery period than if you had come off slowly
  • Overwhelming fatigue causing you to be unable to continue daily tasks or costing your job
  • Having a psychotic break brought on by the terrible insomnia from the rapid withdrawal, and then being locked in a psychiatric ward and being told you are either schizophrenic or most likely that you are Bipolar.
  • Ending up going back on the drugs (each period on the drugs tends to be more dangerous and problematic than the previous time you were on the drugs) and having more drugs added to calm the withdrawal effects
  • Seizures and other life threatening physical reactions
  • Violent outbursts or rages
  • REM Sleep Behavior Disorder which has always been known as a drug withdrawal state and is known to include both suicide and homicide – both committed in a sleep state.

Although my book, Prozac: Panacea or Pandora? Our Serotonin Nightmare!, contains massive amounts of information you can find nowhere else on these drugs, it does not have the extensive amount of information contained in the CD focusing mainly on withdrawal issues. The CD contains newer and updated information on safe withdrawal from these drugs. It details over an hour and a half the safest ways found over the past 30 years to withdraw from antidepressants and the drugs so often prescribed with them – the atypical antipsychotics and benzodiazapenes. And it explains why it is safest to withdraw tiny amounts from all of the medications at the same time rather than withdrawing only one at a time.

It also lists many safe alternative treatments that can assist you in getting though the withdrawal and lists other alternatives to avoid which are not safe after using antidepressants. And it contains information on how to rebuild your health after you have had it destroyed by these drugs so that you never end up feeling a need to be on these drugs again.

The CD is very inexpensive and will save you thousands in medical bills which far too many end up spending trying to do it on your own without this information. (One woman who decided she was okay coming down twice as fast as recommended paid a terrible price. After withdrawing she suffered the REM Sleep Disorder early one morning and attacked her husband with a baseball bat (for which she has no memory) and which ended their lifelong courtship and marriage. And cost her $30,000 to be in a psychiatric facility where they put her on five more drugs plus the antidepressant she had just withdrawn from! You can see why many have lamented that they wished they would have had the information on this CD before attempting withdrawal.

To order Ann Blake-Tracy’s book go to: https://store.drugawareness.org/product/prozac-panacea-or-pandora-our-serotonin-nightmare-2014-ebook-download/

To order the CD, “Help! I Can’t Get Off My Antidepressant!” go to: http://store.drugawareness.org/product/help-i-cant-get-off-my-antidepressant-mp3-download/

This is a CD doctors can also benefit from when attempting to withdraw their patients from these drugs which the World Health Organization has now told us are addictive and produce withdrawal. And doctors have begun to recommend the CD to their patients.

The Aftermath of Antidepressants

In 2005 the FDA issued strong warnings about changes in dose for antidepressants. They warned that ANY abrupt change in dose of an antidepressant, whether increasing or decreasing the dose….so that would include switching antidepressants, starting or stopping antidepressants, forgetting to take a pill, skipping doses, taking a pill one day & not the next, etc…. can cause suicide, hostility, and/or psychosis – generally a manic psychosis which is why so many are given a diagnosis for Bipolar Disorder after this withdrawal reaction that can so severely impair sleep leading to a psychotic break.

Clearly coming down too rapidly can be very, very dangerous. We encourage you to arm yourself with knowledge by downloading our CD on safe withdrawal.

http://www.drugawareness.org/wp-content/uploads/wpsc/product_images/thumbnails/helpicant.jpgclick here. order a CD download.

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!”

 

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