Impact of Antidepressants Upon the Unborn -The Manie Foundation

As of March 17, 2018 it has now been 14 years since Manie was born with a rare heart defect & was rushed into emergency heart surgery when only 8 days old. Then two years ago learned he also has a rare lung defect. And on September 6, 2016 went in for additional surgery. Thus the Manie Foundation was born.

Manie Edgington was born in the heartland of America needing open heart surgery in order to save his life. This was the result of Julie’s extremely short term use of the antidepressant Paxil, a drug she discontinued only a few weeks after his conception when she realized she was pregnant. Sadly for Manie & his mother that was already weeks too late.

This same type of surgery was necessary for two baby boys in my own small Utah neighborhood where the families attended church with me. One of those had also been exposed to Paxil throughout his mother’s pregnancy and the other was exposed to the Prozac residue his mother had taken just before her pregnancy.

With the extremely high rate of use of antidepressants among women of childbearing age this information needs to get out to the public far, far more than what it is now!! How many babies is this happening to that we never hear about, that the mothers never even learn about? I know the stories of the two babies in my neighborhood were never made public in any way whatsoever. The reason for that was with the first one because the mother worked for a pharmacy and she remained on the drug, so she never wanted to take her son’s case to court. The other mother tried to file a case for her son, but as happens so often in going against a drug company with tons of money in their coffers set aside fight such cases, she could not find an attorney who would take her baby’s case pro bono and she did not have the funds to file it herself.

And then in one other case in my small neighborhood, my next door neighbor’s sister, who had been on Prozac for 7 years before weaning off, gave birth to a baby one and a half years after discontinuing her use of Prozac. When the baby was 3 weeks old it was passing more blood than stool. Both her family physician and pediatrician confirmed our fears that it was the Prozac residue in her mother’s milk that was eating away the baby’s intestinal lining. Further confirmation of that came as a mother who had never taken these drugs donated her mother’s milk so that the baby could receive her milk mixed half in half with the mother’s milk which stopped the baby’s intestinal bleeding.

And in two other cases I am aware of another neighbor on Prozac during her pregnancy gave birth to a baby boy with Autism. As he was never given vaccines it was always clear go the parents that Prozac had produced the Autism in their son which because they have chosen for years now to treat with diet & herbs is doing better & better.

The other case involved blood sugar issues. Hypoglycemia was the first birth defect noticed in babies born to mothers who had taken antidepressants. Of course early hypoglycemia would indicate that there is also early diabetes in these babies. A mother on antidepressants was asked to give a talk at church about the safety of antidepressants during pregnancy! That mother went on to assure everyone that her baby was just fine and that using antidepressants during pregnancy was a safe thing to do since she was still on her anti-depressants. What she did not disclose during her presentation was the fact that her baby then only one and a half years old was already suffering such severe diabetes that she was insulin-dependent! Of course anyone knows that means her life will be cut short because of the impact of diabetes at such an early age.

Are these the only problems in children stemming from their mothers use of antidepressants ? Far from it ! These are only some of the life threatening and very serious adverse effects that can come for my mother’s use of antidepressants before and during pregnancy. Much more is coming out now about the depression and anxiety and learning difficulties these children have due to the exposure to these drugs in the womb.

Young women of childbearing age who want families need to to be warned of the many possibilities of the negative impact of the use of an antidepressant upon their offspring instead of being lied to about these drugs being perfectly safe in pregnancy. If they want families they need to know how their use of these drugs can in fact produce life threatening situations for their children and long_term effects which can show up years later.

And this post wood not be complete without including very first comment posted on Facebook in response to this from a mother who was assured over and over again that her medication was safe during pregnancy thus affecting many of her children before one of them did not survive….

 

“I am sick of hearing “I was on antidepressants and my baby was fine.” Everyone assumes that exposure only causes physical defects.
“As a mom with a PPHN baby, a heart defect baby and one who died, plus 3 other living guys exposed (thank you lying medical comminity), you may not notice the impact right away. My 16 year old had a non eventful birth and was a normally healthy baby who was breastfed while I was still on antidepressants, as well as my 11 year old, and both have issues with behaviour and maturing at the same rate as others plus impulse control issues. You know, all the symptoms that get kids medicated for things like ADHD?
“I wonder how many babies born fine grow up to be struggling with problems because their brain was affected while in the womb? You can’t see the brain. There is so much more going on than we know.
“Unless you are of the belief that a mom taking street drugs as opposed to the mom on prescription drugs; your body knows the difference right?”

THE MANIE FOUNDATION

http://www.maniefoundation.org

We love you Manie! I still have the picture I had of you on my desk in Iowa with you in your karate uniform. I hope with this last surgery it did not impair your ability to do your karate in any way.

 

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Chemical Warfare in Syria? Or the United States?

chemical warfare

Chemical Warfare in Syria? Or the United States?

Thanks to our New Zealand director of the International Coalition for Drug Awareness (www.drugawareness.org) and Paul Pezzack from the UK for taking my message about chemical warfare and putting it into a media format that is clear as a bell!!!!!! This is exactly the question I was asking a couple of days ago on our Facebook page about our president being upset enough about the possibility of chemical warfare being used by the government in Syria against their own people!

The question should be “Does it take one to know one?!”

I will be sending out a new study from Harvard in the next day or two that clearly states the data involved in the chemical warfare the US government has unleashed upon the American public via the FDA. This study along with another study by pharmacists, point out that we are losing between 2,300 and 3,300 lives every week in this country to “properly prescribed prescription drugs.” That is a total of between 100,000 to 200,000 deaths per year as a direct result of prescription drugs being used as directed, not abused.

The researchers are also quick to point out that deaths from over-dosing, errors, or recreational drug use would significantly  increase this total. And I would add the death toll from birth defects, and murders and suicides as a result of these drugs would also drastically increase those numbers. Then when you add the deaths and damage from the chemicals allowed in our food supply (farm animals consume more drugs than any other living beings on the planet which are then consumed by an unsuspecting public) and via GMO foods where the one consuming the GMO foods is ingesting the pesticide injected into the seed before planting.

A death toll in those numbers outdoes just about any war I am aware of in our recent past!

https://www.facebook.com/photo.php?fbid=491261724298347&set=gm.1413008715579153&type=1&relevant_count=1&ref=nf

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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Lawsuits for Serious SSRI Birth Defects are Frequent

wide eyed baby pic

Lawsuits for Serious SSRI Birth Defects are Frequent

There are currently so many SSRI birth defect lawsuits that have been filed by families whose infants have been born with these defects that the cases are being consolidated in a massive legal action in the federal court system.

Among the health problems that women claim were caused in their infants because of the use of SSRIs during pregnancy are:

* A life-threatening lung condition known as – Persistent Pulmonary Hypertension of the Newborn
*Club Foot
*Cleft Palate
*Cleft Lip
*Ventricular septal malformation
*Omphalocele
*Tetralogy of Fallot
*Limb deformities
*Genital defects
*Heart defects
*Abnormal intestinal defects
*Hydrocephalus
*Atrial septal defect
*Ventral septal defect

Now, the findings of a new study published in the British Medical Journal show that patients taking SSRIs may be at higher risk of developing an abnormal heart beat than patients who take other medications.

[What they are talking about here is the long QT interval that I have been discussing for years and included much information on this in the 2000 edition of Prozac: Panacea or Pandora? – Our Serotonin Nightmare.]

Among the birth defects identified in these SSRI lawsuits are nearly every one of the complaints the mothers had listed:

*Persistent Pulmonary Hypertension of the Newborn
*Heart defects
*Ventricular septal malformation
*Atrial septal defect
*Tetralogy of Fallot
*Cleft lip
*Cleft palate
*Club foot
*Omphalocele
*Limb deformities
*Genital defects
*Abnormal intestinal defects
*Hydrocephalus

In the new research linking SSRIs to increased risk of stroke, the findings of the research, which were published in the journal Neurology, the scientists found that the increased risk of stroke occurs most often during the first few weeks of treatment.

I will follow this up with new research just out that will demonstrate serious problems for the mother after pregnancy due to her use of antidepressants.

– See more at: http://www.resource4thepeople.com/defectivedrugs/SSRI-Birth-Defects.html#sthash.0BfFrwpA.dpuf

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!

 

 

 

– See more at: http://www.resource4thepeople.com/defectivedrugs/SSRI-Birth-Defects.html#sthash.0BfFrwpA.dpuf

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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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Understanding Paxil Birth Defects

Ann Blake-Tracy says:

Your comment is awaiting moderation.

After two decades of tracking mothers and babies exposed to SSRI
antidepressants during pregnancy I shutter to ever see a mother take one of
these drugs. If those adverse effects listed in this article are not bad enough
to consider exposing a baby to, we have yet to witness the full effects of these
drugs upon offspring. These babies brains will not be fully developed until they
are in their 20’s. The full negative effects upon that developing brain will not
be known until then. Knowing what I know after 20 years of researching these
drugs and tracking patients who have taken them, I DO NOT WANT TO SEE WHAT IS
COMING!!

Ann Blake-Tracy, Executive Director,
International Coalition for Drug
Awareness
https://www.drugawareness.org & http://www.ssristories.drugawareness.org

Understanding Paxil Birth Defects

In December 2005, GlaxoSmithKline (GSK) posted its Paxil findings on its
website regarding pregnant women taking antidepressants. In this announcement,
GSK noted that it was revising its pregnancy precaution category from C to D.
This revision was based on recent studies that indicated positive evidence of
human fetal risk. In addition, GSK was placing this information in the WARNINGS
section of the Paxil label.
The FDA then advised pregnant women to switch from Paxil to another SSRI
drug, such as Prozac or Zoloft. This warning was based on the results of an
analysis of Sweden’s birth registry that showed women who took Paxil were 1.5 to
2 times more likely to give birth to a baby with heart defects than women who
took other selective serotonin reuptake inhibitors (SSRIs) or no antidepressant
at all.
Studies also showed that complications were reported for babies born to
mothers who had taken antidepressants such as Paxil in the third month of
pregnancy. Such complications included breathing difficulties, turning blue,
seizures, changing body temperature, feeding problems, vomiting, low blood
sugar, stiffness, tremor, irritability or constant crying. In other words, just
like adults, newborn babies of mothers who have taken Paxil while pregnant,
experience similar withdrawal symptoms. Because of this, tube feeding, help with
breathing and longer hospitalization may be needed. Premature births in pregnant
women exposed to SSRIs such as Paxil have also been reported.
Based on such reports obstetricians went so far as to recommend that
women avoid Paxil and reconsider using any SSRI antidepressant during pregnancy.
Still, other physicians maintain that the benefits of mothers getting treatment
for their depression outweigh the risks to the fetus.
The most common birth defects caused by antidepressants have been found
to be holes or other malformations in the chambers of the heart. Often the

defects heal on their own, but more severe cases need surgical procedures. GSK
is investigating how Paxil could be causing such defects.
In addition, antidepressant drugs are known to imbalance blood sugar
metabolism thereby worsening gestational diabetes. However, it is doubtful that
this is explained to expectant mothers who are given such drugs.
Medical professionals in women’s mental health point out that it is
important to aptly gauge the timing of medications prescribed for women who are
pregnant. Paxil is currently one of the most popular antidepressants in the
world, and roughly 25 percent of its users are women of childbearing age —
between 18 and 45.

Nick Johnson serves as lead counsel with Johnson Law Group, with principal
offices located in Houston, Texas. Johnson represents plaintiffs with injury
cases involving Defective Drugs. Contact Nick Johnson at 1-888-311-5522 or visit
http://www.johnsonlawgroup.com

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SSRI Antidepressants Linked to Lactation Difficulties

NOTE BY Ann Blake-Tracy (www.drugawareness.org): The following
statement about the benefits of breastmilk are true. But when you are talking
about the benefits of breastmilk coming from a mother on SSRI antidepressants,
there is no basis for benefit from such contaminated milk. The baby is much
better off gathering milk from a mother who is drug free. The only additional
problem at that point is that if the baby survives and does not die from one of
the many horrific birth defects produced by these drugs they will then be
going cold turkey off one of these very addictive antidepressants. It would be
better to wean the baby slowly down off of the breast milk by giving smaller and
smaller amounts of the mother’s toxic contaminated milk while providing more and
more clean breast milk from a donor mom.

Let me give just one example of why I would say this: Over the weekend I
was able to visit once again with a mother of seven that I helped years ago
as she withdrew from her seven year use of Prozac. After she had been completely
off the drug for a year and a half she gave birth to her last child. When the
baby was three weeks old she was passing more blood than stool. Both the family
physician and the pediatrician agreed that it was the Prozac residue in the
mother’s breast milk that was eating away the baby’s intestinal lining to cause
the bleeding. They confirmed this by having the mother gather clean breast milk

to supplement her milk with. Almost immediately after mixing the milk half and
half the bleeding stopped. So, assisting a mother to breastfeed when her milk is
so contaminated may not be in the best interest of the baby after all.

_______________________________
Breastfeeding benefits both infants and mothers in many ways as breast milk
is easy to digest and contains antibodies that can protect infants from
bacterial and viral infections. The World Health Organization recommends that
infants should be exclusively breastfed for the first six months of life. This
new study shows that certain common antidepressant drugs may be linked to a
common difficulty experienced by new mothers known as delayed secretory
activation, defined as a delay in the initiation of full milk secretion.
Public release date: 26-Jan-2010

Contact:
Aaron Lohr
alohr@endo-society.org
240-482-1380
The
Endocrine Society

Common antidepressant drugs linked to lactation difficulties in
moms

According to a new study accepted for publication in The Endocrine Society’s
Journal of Clinical Endocrinology & Metabolism (JCEM), women
taking commonly used forms of antidepressant drugs may experience delayed
lactation after giving birth and may need additional support to achieve their
breastfeeding goals.

Breastfeeding benefits both infants and mothers in many ways as breast milk
is easy to digest and contains antibodies that can protect infants from
bacterial and viral infections. The World Health Organization recommends that
infants should be exclusively breastfed for the first six months of life. This
new study shows that certain common antidepressant drugs may be linked to a
common difficulty experienced by new mothers known as delayed secretory
activation, defined as a delay in the initiation of full milk secretion.

“The breasts are serotonin-regulated glands, meaning the breasts’ ability to
secrete milk at the right time is closely related to the body’s production and
regulation of the hormone serotonin,” said Nelson Horseman, PhD, of the
University of Cincinnati and co-author of the study. “Common antidepressant
drugs like fluoxetine, sertraline and paroxetine are known as selective
serotonin reuptake inhibitor (SSRI) drugs and while they can affect mood,
emotion and sleep they may also impact serotonin regulation in the breast,
placing new mothers at greater risk of a delay in the establishment of a full
milk supply.”

In this study, researchers examined the effects of SSRI drugs on lactation
using laboratory studies of human and animal cell lines and genetically modified
mice. Furthermore, an observational study evaluated the impact of SSRI drugs on
the onset of milk production in postpartum women. In this study of 431
postpartum women, median onset of lactation was 85.8 hours postpartum for the
SSRI-treated mothers and 69.1 hours for mothers not treated with SSRI drugs.
Researchers commonly define delayed secretory activation as occurring later than
72 hours postpartum.

SSRI drugs are very helpful medications for many moms, so understanding and
ameliorating difficulties moms experience can help them achieve their goals for
breastfeeding their babies,” said Horseman. “More human research is needed
before we can make specific recommendations regarding SSRI use during
breastfeeding.”

###

Other researchers working on the study include: Aaron Marshall, Laura
Hernandez and Karen Gregerson of the University of Cincinnati in Ohio; Laurie
Nommsen-Rivers of Cincinnati Children’s Hospital Medical Center in Ohio; Kathryn
Dewey of the University of California at Davis; and Caroline Chantry of the
University of California Davis Medical Center in Sacramento.

The article, “Serotonin transport and metabolism in the mammary gland
modulates secretory activation and involution,” will appear in the February 2010
issue of JCEM.

Founded in 1916, The Endocrine Society is the world’s oldest, largest and
most active organization devoted to research on hormones and the clinical
practice of endocrinology. Today, The Endocrine Society’s membership consists of
over 14,000 scientists, physicians, educators, nurses and students in more than
100 countries. Society members represent all basic, applied, and clinical
interests in endocrinology. The Endocrine Society is based in Chevy Chase,
Maryland. To learn more about the Society and the field of endocrinology, visit
our site at www.endo-society.org.

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SSRI Birth Defects: Glaxo must pay $2.5M in Paxil case

The verdict is the first in 600 cases alleging that
London-based Glaxo knew Paxil caused birth defects and hid those risks to boost
profits.

The drug, approved for U.S. use in 1992, generated about $942
million in sales last year, 2.1 percent of Glaxo‘s total revenue.

Michelle David had claimed that her 3-year-old son Lyam Kilker
suffered life-threatening heart defects because she took Paxil while she was
pregnant with him.

Posted on Tue, Oct.
13, 2009

Glaxo must pay $2.5M in Paxil case

By Miriam Hill

INQUIRER STAFF WRITER

GlaxoSmithKline P.L.C. must pay $2.5 million to settle a
claim that its Paxil antidepressant caused severe heart defects in a
3-year-old Bensalem boy, a Philadelphia common pleas jury ruled
today.

The verdict is the first in 600 cases alleging that
London-based Glaxo knew Paxil caused birth defects and hid those risks to
boost profits.

The drug, approved for U.S. use in 1992, generated about $942
million in sales last year, 2.1 percent of Glaxo‘s total
revenue.

London-based Glaxo has major operations in the Philadelphia
region.

Michelle David had claimed that her 3-year-old son Lyam
Kilker suffered life-threatening heart defects because she took Paxil while
she was pregnant with him.

Glaxo issued a statement saying it disagrees with the verdict
and will appeal.

“While we sympathize with Lyam Kilker and his family, the
scientific evidence does not establish that exposure to Paxil during pregnancy
caused his condition. Very unfortunately, birth defects occur in three to five
percent of all live births, whether or not the mother was taking medication
during pregnancy,” the company’s statement said.

David and Kilker’s lawyers, Sean Tracey of Houston and Jamie
Sheller of the Philadelphia firm Sheller P.C., argued that Glaxo withheld
information from consumers and regulators about the risk of birth defects and
failed to properly test Paxil.

“The first win is always huge, especially when you get a jury
saying the drug caused the injury,” Sean Tracey, Kilker’s lawyer, told
Bloomberg in an interview after the jury reached its decision.

Glaxo‘s lawyer, Chilton Varner of King & Spalding in
Atlanta, countered that the company reported any sign of problems to federal
authorities. She had accused Tracey of cherry-picking sentences from
documents.

During the trial, she also noted that Kilker, who underwent
several surgeries to fix his heart problems today “has no cardiac symptoms . .
.. is at preschool and runs and walks like an [almost] 4-year-old
should.”

In its statement today, Glaxo said it “acted properly and
responsibly in conducting its clinical trial program for Paxil, including
sharing documentation and submitting results from studies on Paxil to
regulators.”

Kilker will require more surgeries as he
grows.

David was a former cheerleader for the Philadelphia
76ers.

The case was heard by Judge Stephen Levin in Common Pleas
Court.

The FDA initially classified Paxil as a drug with no known
connections to birth defects. In 2005, the agency reclassified it as a drug
with some evidence of human fetal risk but allowed doctors to continue
prescribing it to women of childbearing age if the benefits outweigh the
risks.


Contact staff writer Miriam Hill at 215-854-5520 or hillmb@phillynews.com.

This story contains information from Bloomberg
News.

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PAXIL: BIRTH DEFECTS – TEST CASE FOR OVER 600 MORE CASES – USA

First two paragraphs read:  “GlaxoSmithKline P.L.C., the
world’s second-biggest drugmaker, begins a trial in Philadelphia next week in
what may be a test case for more than 600

lawsuits over claims that the company’s antidepressant drug Paxil causes birth defects.”

“Patients and their parents say internal company documents
show Glaxo failed to warn consumers about the risks of Paxil until forced
to do so in 2005 by the Food and Drug Administration.
In the trial set
to start Monday, Michelle David blames the drug for causing life-threatening
heart defects in her son, Lyam Kilker, now age 3.”

Glaxo trial opens here Monday in what could be Paxil test case

By Sophia Pearson and Margaret Cronin Fisk

Bloomberg
News
GlaxoSmithKline P.L.C., the world’s second-biggest drugmaker, begins a
trial in Philadelphia next week in what may be a test case for more than 600

lawsuits over claims that the company’s antidepressant drug Paxil causes birth
defects.

Patients and their parents say internal company documents show
Glaxo failed to warn consumers about the risks of Paxil until forced to do so in
2005 by the Food and Drug Administration. In the trial set to start Monday,
Michelle David blames the drug for causing life-threatening heart defects in her
son, Lyam Kilker, now age 3.

The company, based in London and with major
operations in Philadelphia and its suburbs, faces two more such trials each
month from October through January in state court in Philadelphia.

“The
early cases set the parameters for any global settlement negotiations,” said
David Logan, dean and professor of law at Roger Williams University in Bristol,
R.I.

Paxil, approved by the FDA in 1992, generated about $942 million in
sales last year, 2.1 percent of the total for the company.

Glaxo has
settled other Paxil-related cases, including a suit brought by the New York
Attorney General’s Office accusing the company of withholding safety data about
the antidepressant.

The drugmaker isn’t liable for Lyam Kilker’s heart

defects, and it acted responsibly in testing Paxil and updating safety
information, Kevin Colgan, a Glaxo spokesman, said in an e-mail.

“The
scientific evidence simply does not establish that exposure to Paxil during
pregnancy caused Lyam Kilker’s condition,” Colgan said. “Very unfortunately,
birth defects occur in 3 to 5 percent of all live births, whether or not the
mother was taking medication during pregnancy.”

The FDA said in an alert
to doctors on Dec. 8, 2005, that preliminary studies suggested Paxil might
contribute to heart defects in infants when taken in the first three months of
pregnancy. The government asked the company to update the label enclosed with
the medicine, changing its birth-defect warning.

The FDA’s action does
not prove any connection between Paxil use and birth defects, Glaxo said in
court filings in July.

“GlaxoSmithKline will show it acted properly and
responsibly in conducting its clinical trial program for Paxil, in marketing the
medicine, in monitoring its safety once it was approved for use and in updating
pregnancy information in the medicine’s label as new information became
available,” Glaxo’s Colgan said.

Lawyers for patients say Glaxo
documents show the company had known since 1980 that Paxil could raise the risk
of birth defects.

Buzz
up!
Buzz this story.

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SSRI: 100-500% Increased Risk of Heart Birth Defects If Taken In Early Pregnancy

NOTE FROM Ann Blake-Tracy (www.drugawareness.org): This new study SHOULD stop the Mother’s Act dead in its tracks! The Mother’s Act is designed to medicate pregnant and nursing mothers for depression and we know what they medicate them with – these drugs that they have just shown amazingly damaging effects upon the heart of the fetus!

ANY YOUNG WOMAN WHO INTENDS TO HAVE A FAMILY SHOULD BE WARNED OF THIS POSSIBILITY OF SERIOUS LIFE THREATING BIRTH DEFECTS IN HER OFFSPRING BEFORE EVER BEING STARTED ON AN SSRI ANTIDEPRESSANT!! Marketing these drugs to this age group should be considered criminal when you look at what this study shows to be the risks to the children born to these mothers.

And if you think this does not affect you, think again. You need to see what these children go through (if they survived their mother’s use of these drugs) throughout their lives due to their mother’s use of these drugs! Who do you think ends up paying the bills for the numerous reconstructive surgeries, the lifetime of medications and medical treatment? We do. All of us in higher insurance rates, disability payments, etc., etc., etc.

PLEASE CAREFULLY EXAMINE THE FOLLOWING RESULTS OF THIS STUDY AND SHARE IT WITH EVERYONE YOU KNOW!!! Doing so may spare at least one baby from this horror.

Here is just one small example: http://bigpharmavictim.blogspot.com Manie’s mother was given Paxil and assured it would be okay as so many mothers are told. Her infant son, Manie, was born with Transposition of the Great Arteries and had to have open heart surgery when he was only 8 days old. The surgery lasted 12 hours.
___________________________

Paragraph one reads: “If you take antidepressants such as fluoxetine (marketed as Prozac) early in your pregnancy, you may be doubling the risk that your newborn will be born with a heart defect, according to a new study.”

Paragraph four reads: “Along with fluoxetine, sertraline (marketed as Zoloft) and citalopram (marketed as Celexa) seemed to increase the risk more than others, as did using more than one antidepressant at a time, according to the report in the September 25th Online First issue of BMJ.”

Paragraph six reads: “Sertraline [Zoloft] more than tripled the risk, while citalopram [Celexa] more than doubled it. Using more than one SSRI nearly quintupled the risk of the heart defect.”

http://www.reuters.com/article/healthNews/idUSTRE58O39F20090925

Antidepressants in pregnancy up heart defect risk
Fri Sep 25, 2009 9:58am EDT Email | Print | Share| Reprints | Single Page[-] Text [+]

By Anthony J. Brown, MD

NEW YORK (Reuters Health) – If you take antidepressants such as fluoxetine (marketed as Prozac) early in your pregnancy, you may be doubling the risk that your newborn will be born with a heart defect, according to a new study.

However, the vast majority of children born to women who take such antidepressants – known as selective serotonin reuptake inhibitors (SSRIs) – do not have such defects, the researchers are quick to note.

Earlier studies have tied SSRIs during pregnancy to heart defects, but also to even more serious birth defects. According to the new study of nearly half a million children born in Denmark between 1996 and 2003, however, only heart defects are likely to be associated with the antidepressants, note co-author Dr. Lars Henning Pedersen, from Aarhus University, Denmark, and colleagues.

Along with fluoxetine, sertraline (marketed as Zoloft) and citalopram (marketed as Celexa) seemed to increase the risk more than others, as did using more than one antidepressant at a time, according to the report in the September 25th Online First issue of BMJ.

Overall, SSRI use in early pregnancy, defined as 28 days before to 112 days after conception, doubled the risk of a particular kind of heart defect involving a piece of tissue that separates parts of the heart.

Sertraline more than tripled the risk, while citalopram more than doubled it. Using more than one SSRI nearly quintupled the risk of the heart defect.

However, the number of children born with such defects was still quite small: For about every 250 pregnant women who did not take SSRIs, one infant was born with the defect, while about two were born with the defect for every 250 women who took one SSRI, and four for every 200 mothers who took more than one.

Pedersen told Reuters Health that the results surprised the team.

Still, in an accompanying editorial, Dr. Christina Chambers, from the University of California, San Diego, comments that doctors and patients “need to balance the small risks associated with SSRIs against those associated with undertreatment or no treatment.”

SOURCE: BMJ, online September 25, 2009.

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PAXIL TRIAL: Glaxo Executive’s Memo Suggested Burying Drug Studies (Update4)

An executive of GlaxoSmithKline Plc, the world’s second-biggest drugmaker, talked about burying negative studies linking its antidepressant drug Paxil to birth defects, according to a company memo introduced at a trial.
“If neg, results can bury,” Glaxo executive Bonnie Rossello wrote in a 1997 memo on what the company would do if forced to conduct animal studies on the drug. The memo was read during opening statements in the trial of a lawsuit brought by the family of a child born with heart defects.

The Philadelphia trial is the first of more than 600 cases alleging that London-based Glaxo knew Paxil caused birth defects and hid those risks to pump up profits.

NOTE BY Ann Blake-Tracy (www.drugawareness.org): In my small church congregation in Utah (maybe 100 families) there were two cases of SSRIs birth defects that I was aware of. In one case the mother was on Paxil and the other was a mother on Prozac. Both babies had to have heart surgery at birth or not long after. Because of that the number of 600 cases that have been filed is no surprise to me at all other than the number seems small in comparrison.

http://www.bloomberg.com/apps/news?pid=20670001&sid=ae8Ie3hNoafw

Glaxo Executive’s Memo Suggested Burying Drug Studies (Update4)
Share | Email | Print | A A A

By Jef Feeley and Margaret Cronin Fisk

Sept. 15 (Bloomberg) — An executive of GlaxoSmithKline Plc, the world’s second-biggest drugmaker, talked about burying negative studies linking its antidepressant drug Paxil to birth defects, according to a company memo introduced at a trial.

“If neg, results can bury,” Glaxo executive Bonnie Rossello wrote in a 1997 memo on what the company would do if forced to conduct animal studies on the drug. The memo was read during opening statements in the trial of a lawsuit brought by the family of a child born with heart defects.

The Philadelphia trial is the first of more than 600 cases alleging that London-based Glaxo knew Paxil caused birth defects and hid those risks to pump up profits. The drug, approved for U.S. use in 1992, generated about $942 million in sales last year, 2.1 percent of Glaxo’s total revenue.

The family of Lyam Kilker claims Glaxo withheld information from consumers and regulators about the risk of birth defects and failed to properly test Paxil. Kilker’s mother, Michelle David, blames Paxil for causing life-threatening heart defects in her 3-year-old son.

Glaxo officials urged scientists to withhold information about Paxil’s risks from a paper laying out the company’s “core safety philosophy” for the drug, said Sean Tracey, a lawyer for Kilker and David, in his opening statement in the trial.

“They said if there’s any doubt, take it out,” Tracey told jurors. “They do not want to scare anybody. It’s a very competitive marketplace. It’s a multibillion-dollar industry.”

‘Rare Thing’

Glaxo executives contend that the boy’s heart defect wasn’t caused by Paxil, Chilton Varner, one of the company’s lawyers, told jurors today in her opening statement. In court filings, Glaxo has said it appropriately tested and marketed the antidepressant drug.

“When Lyam Kilker was born in 2005, GSK had not received notice” of his specific type of heart defect in connection with Paxil use, Varner said. “The numbers will tell you the defect is a rare thing.”

The Paxil label at that time reported about animal studies, “including the rate of deaths,” she said.

Glaxo didn’t target pregnant women and its sales force didn’t use strong-arm tactics to push prescriptions, Varner said. “Whatever the marketing was, it played no role in Ms. David’s doctors’ decision to prescribe Paxil or Ms. David’s decision” to take the drug, she said.

Rat Studies

Glaxo officials purchased the compound sold as Paxil from a Danish company that had done animal studies showing young rats died after taking low doses of the drug, Tracey said in his opening statement.

One of the company’s scientists noted in internal documents in 1980 that information in the rat studies suggested Paxil “could be” a cause of birth defects, Tracey said. Still, the drugmaker refused for almost 20 years to do studies on why the young rats died, he added.

Tracey told jurors they would see documents in the trial that the company hadn’t turned over to regulators or congressional investigators. “You are going to see docs that have never seen light of day before,” he said.

For example, Tracey pointed to a 1998 internal review by Glaxo of all reports of side effects tied to Paxil and officials found “an alarmingly high number” of birth-defect reports. Even with those concerns, the report was never turned over to the U.S. Food and Drug Administration and “the alarming language” was deleted from it, the lawyer said.

In 2001, the company received a letter from a woman who used Paxil during her pregnancy and decided to abort her fetus after tests showed it had birth defects, Tracey said.

Internal Report

In analyzing the woman’s case, Glaxo officials concluded in an internal report that it was “almost certain” the fetus’s birth defects were caused by his mother’s Paxil use, the family’s lawyer added. Still, the company didn’t turn over its analysis to the FDA or beef up the drug’s warning label, Tracey said.

It wasn’t until after the FDA ordered Glaxo and other makers of antidepressants in 2003 to do more safety studies on their products that Glaxo officials publicly acknowledged that Paxil increased the risk of birth defects, Tracey said.

The lawyer for David, a college nursing student who was a former cheerleader for the National Basketball Association’s Philadelphia 76ers, told jurors that Glaxo hid Paxil’s problems to protect its profits.

Paxil is “the No. 1 asset to this day this company has ever owned,” the attorney said.

‘Quite Different’

Varner said she will present “quite different” evidence on animal tests tied to Paxil.

“The animal testing did not suggest Paxil caused birth defects,” Varner said. The FDA considered the tests when it approved the drug for use by U.S. consumers in 1992, she said.

When Glaxo officials considered offering Paxil for sale in Japan, internal records show executives worried in 1994 they might have to do more safety testing on the antidepressant, said Dr. David Healy, an Irish psychiatrist testifying as an expert for Kilker’s family in the case.

It may be the “type of study we wish to avoid,” Jenny Greenhorn, an official in Glaxo’s international regulatory affairs unit, said in a memo.

Glaxo also is fighting suits in the U.S., Canada and the U.K. over claims that Paxil, also known by the generic name paroxetine, causes homicidal and suicidal behavior. The company has settled some suicide claims, though terms of the settlements haven’t been released.

New York Settlement

In 2004, the drugmaker agreed to pay the state of New York $2.5 million to resolve claims that officials suppressed research showing Paxil may increase suicide risk in young people. The settlement also required Glaxo to publicly disclose the studies.

The company’s provision for legal and other non-tax disputes as of June 30 was 1.7 billion pounds ($2.8 billion), the company said in a July 22 regulatory filing that didn’t mention the Paxil litigation.

“We do not disclose our legal reserves for any specific litigation matter,” Glaxo spokesman Kevin Colgan said earlier this month.

Glaxo American depositary receipts, each representing two ordinary shares, fell 68 cents, or 1.7 percent, to $38.76 in New York Stock Exchange composite trading today. Glaxo fell 14 pence, or 1.2 percent, to 1,175.5 pence in London.

The case is Kilker v. SmithKline Beecham Corp. dba GlaxoSmithKline, 2007-001813, Court of Common Pleas, Philadelphia County, Pennsylvania.

To contact the reporters on this story: Jef Feeley in Philadelphia jfeeley@bloomberg.net; Margaret Cronin Fisk in Southfield, Michigan, at mcfisk@bloomberg.net.

Last Updated: September 15, 2009 17:03 EDT

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