The Bitter Pill

The Official Blog of UNITE – uniteforlife.org

Over Six Hundred and Counting – Paxil Birth Defect Cases by Evelyn Pringle

Over Six Hundred and Counting -  Paxil Birth Defect Cases
by Evelyn Pringle

Since Paxil came on the market in 1992, there have been three separate types of failure to warn lawsuits filed against GlaxoSmithKline over Paxil; birth defects, suicide, and addiction.

Roughly 150 suicide cases were settled for an average of about $2 million, and about 300 cases involving suicide attempts were settled for an average of $300,000, according to a December 14, 2009 report by Bloomberg News. Glaxo paid an average of about $50,000 each to resolve about 3,200 cases linking Paxil to addiction problems. The drug giant has also paid about $400 million to end antitrust, fraud and design claims, Bloomberg reports.

All total, Glaxo has paid out close to $1 billion to resolve Paxil lawsuits since the drug came on the market in1992. The company’s provision for all legal matters and other non-tax disputes as of the end of 2008 was listed as $3.09 billion in its annual report.

The first birth defect trial, in over 600 cases filed, resulted in a verdict for the plaintiffs on October 13, 2009, and an award of  of $2.5 million in compensatory damages for the the family of Lyam Kilker, who was born with three cardiac birth defects after his mother took Paxil while pregnant.

In the Kilker trial, Glaxo’s lead attorney was King & Spalding partner, Chilton Varner, and Sean Tracey, from Houston, led the family’s legal team.

Andy Vickery, of the Houston firm of Vickery, Waldner and Mallia, is the lead attorney in several Paxil birth defect cases.  The first case set for trial is unique in that it involves, Delaney Novak, an infant born with heart defects on April 4, 2002, to Laura and Derek Novak, after Laura was prescribed Paxil off label for migraine headaches.

The Novak case is also unique among the Paxil birth defect cases because Delaney’s parents had their insurance with United Healthcare, and Laura was part of the study that Glaxo contracted for, which resulted in the initial warning letter about birth defects in September 2005.

According to Vickery, Glaxo conducted a study on Wellbutrin (bupropion), another antidepressant, after discovering a possible link to birth defects. “The review found no problems with Wellbutrin, but discovered that a significant number of mothers who had been prescribed Paxil (nearly twice as many as those who had not taken the drug) had children born with heart defects,” he says.

Doctors Ra-id Abdulla, David Healy, Shira Kramer and Suzanne Parisian testified as the experts for the plaintiffs in the first trial. All told the jury they believed Paxil caused Lyam’s heart defects. Doctors Abdulla, Healy and Kramer are also expert witnesses in the Novak case.

Ingenix Study in First Trial

The Ingenix study, with lead researcher, J Alexander Cole, was conducted using data from the Ingenix Research Data Mart, containing insurance information from UnitedHealthcare. The study was not supposed to look at Paxil.

During the testimony of several witnesses in the first trial, the jury was shown a February 7, 2003 email in which Glaxo employee, Graham Cottam, stated that he had informed Anne Bell, the project leader for Paxil, about plans to do the Ingenix pregnancy study on Wellbutrin, and “Anne wanted to be sure that we will not be looking specifically SSRIs or Paxil.”

Doctor Suzanne Parisian, a former FDA scientist, testified that the initial 2002 proposal was “to do a large database study for Bupropion in pregnancy.”

There was “nothing that addresses Paxil,” she told the jury. The “procedure had never been designed to specifically look at Paxil.”

But when the data was broken out for Paxil in the original study, it “showed the increased risk and the pregnancy was changed to Category D,” she explained.

The FDA later requested that Paxil be studied, according to the testimony of Glaxo employees and documentation, she said.

The famous neuropyschopharmacologist and professor of psychiatry from Cardiff University in Wales, Dr  David Healy, explained that Glaxo had hopes that the study would show Wellbutrin as an antidepressant that did not cause birth defects and the company could apply to the FDA to have it classified as a pregnancy category B drug instead of a C.

“It would give the message,” he said, “that this of the drugs we have available to use for women of childbearing years, this would be one of the safer ones.”

Healy told the jury that there was “no reason from the scientific point of view why they would not want to also look at Paxil.”

“And this appeared to be the FDA’s view,” he said, “because FDA said, well, you looked at Bupropion, why don’t you look at Paxil, also,” a couple years later.

When asked whether by the year 2003, he could think of any scientific reason not to do a pregnancy study with Paxil, Healy replied, “No, I can’t.”

In fact, Tracey showed the jury an internal company email written by a Glaxo employee two years later in August 2005, around the time that the results on Paxil from the Ingenix study came out, who asked the question: “Why hasn’t the company gathered data on this until now, 13, I think, years after the product was approved?”

In the case of the study on Wellbutrin, there were only 16 reports of birth defects that indicated there was a signal to do the study, Parisian told the jury. While an internal analysis conducted by Glaxo on Paxil in 2000, showed 79 cases of birth defects.

In September 2005, the conclusions of the Ingenix study were: “The use of paroxetine in the first trimester of pregnancy was associated with an increased risk of congenital malformations compared with other drugs.”

“To your knowledge, prior to 2005 did GSK ever do a single epidemiological study to determine whether or not Paxil caused birth defects?” attorney, Adam Peavey, asked Parisian.

“Not that I have seen,” she said.

Ingenix Downside

During the testimony of Dr Shira Kramer, an epidemiologist, Tracey put up a slide on the Cole paper that was published in 2007.

The paper was on a study conducted by epidemiologists who were employed by Glaxo to do the research, Kramer explained. It was a continuation of the Ingenix study that looked at Wellbutrin and then Paxil. One of the co-authors was Sara Ephross, an employee of Glaxo.

Kramer was asked to explain the importance of the Cole study. “First of all,” she said, “it was a cohort study comparing … people exposed to Paxil … to people who were exposed to other SSRIs.”

“So one very key thing for you to remember is that here the … unexposed group is not people who were not exposed to SSRIs, they were exposed to SSRIs,” she told the jury.

“That’s a very important point,” she said, “because if SSRIs are a risk factor for cardiac defects, birth defects, then the relative risk that will be generated in this study is going to be lower than it normally would if truly people were unexposed to SSRIs.”

“The other thing that is important to keep in mind,” she told the jury, “is that the information was obtained from an administrative claims database called the Ingenix Research Data Mart. “

“There was no individual, either examination or interviewing of anyone,” she explained. “The information was extracted from administrative claims data that was available.“

“The other thing that’s important,” she said, “is that initially the population that was studied covered the years 1995 to 2002, and then after the fact an additional two years were added to the study.”

“The published results, based on all of the years that were eventually included in this study, were an odds ratio for all cardiovascular malformations related to Paxil exposure of 1.46, which means that individuals who took Paxil were at 46 percent increased risk of their child having a cardiovascular malformation diagnosed at birth compared to individuals who took other, other SSRIs,” Kramer explained.

“In the second odds ratio of 1.68,” she said, “showing a 68 percent increased risk, now we are comparing women who took Paxil either alone or in combination with another SSRI, compared to the other SSRI group, either alone or in combination with other SSRIs, mono- or polytherapy.”

The published study contained an asterisk that said: “An interim analysis performed by Cole, et al, using births occurring between ’95 and 2002 found an odds ratio of 2.0 for the association between first trimester Paxil use and cardiac birth defects.”

Kramer was asked to explain what that statement was referring to. “Initially, the study was designed to include the years 1995 through 2002 with a sampling ratio of controls to cases of 7 to 1,” she said. “That was the protocol.”

“And when that analysis was done, the odds ratio, instead of being 1.46, which ultimately is what was published, was actually higher, it was 2,” she told the jury.

“That means that the exposed group had a risk of a child with a cardiac malformation two times that of the group not exposed to Paxil,” she added.

The odds ration got smaller when the Glaxo researchers, the authors of the study, “added in two additional years of data with a different sampling ratio,” Kramer explained.

It is not appropriate for an epidemiologist to do that, she said, because “you are changing the rules after you look at the data.”

It “really raises the questions as to, are you trying to influence the data,” she noted.

“I can say very clearly,” she told the jury, “that that is not considered to be appropriate conduct, scientific conduct. “

“What you are supposed to do is set up a study protocol in advance and follow it, and not change it after you have looked at the results,” Kramer explained.

It is not appropriate to find out the results and change it in the middle, she said, “for obvious reasons, it looks like you are manipulating the data to make it come out looking a certain way.”

“And if you want to do an unbiased, fair study,” she told the jury, “the only appropriate plan of action is to develop a study protocol ahead of time, to follow it, and to analyze the results and not to fool with it, not to fiddle with it and not to change it.”

While testifying, Kramer explained the meaning of “underpowering” a study. You need to have “a sufficient number of people in a study in order to test a certain research question,” she said.

“And if you are going to apply statistical tests to the data that you generate,” she told the jury, “you need to have enough people in that study to have generated enough cases of the outcome and you need to have enough people who are exposed.”

“Now, this case,” she said, “we have got a relatively rare exposure to Paxil, we have a relatively rare outcome, which is congenital cardiac birth defects, so you need to study very, very large populations in order to achieve statistical significance at these levels that we have been discussing.”

She said the “investigators, the research team,” dictates the size of the study.

Kramer went over the reasons why the odds ratio in the Cole study might be attenuated, or lower. It’s “very clear that there are certain characteristics of this study that are making this odds ratio probably lower than it really would be given certain characteristics of the study design,” she told the jury.

“One of the them is that the controls are really not unexposed to the SSRIs,” she said. “They are exposed to drugs in the same class.”

We have “observed in epidemiological literature that other SSRIs are associated with an increased risk of cardiac malformations,” she told the jury. “Therefore, it is likely that since that’s the comparison group, we have got an odds ratio in this study that’s lower than it probably would be.”

The second reason was that the analysis only included live births. “So you are missing fetuses who were miscarried,” she said. “And then there are many miscarriages that are due to birth defects.”

“You are missing fetuses that are aborted, electively aborted, because of known cardiac or other congenital malformations,” she told the jury. “You are missing stillbirths.”

And with a follow up for only nine months, she said, “you are missing congenital cardiac defects that aren’t detected until later.”

“So you have got a fairly substantial population that is not really being captured in this study of exposed fetuses,” she pointed out.

Closing Recap

During closing arguments, Tracey reminded the jury about the email with Anne Bell’s statement to make sure Paxil was not included in the Ingenix study, and said: “This document … two years before this child is born, they are affirmatively saying: We do not want to look at Paxil in pregnancy.”

In her closing argument, Varner told the jury: “Now, Mr. Tracey has talked to you about Anne Bell this morning.”

“He has said that GSK would have done anything to avoid looking at the risk for Paxil,” she pointed out.

“Well, ladies and gentlemen,” Varner said, “GSK funded the study that did look at Paxil for the risk and published preliminary findings in August of 2005.”

As soon “as even a possible link emerged in all of 2005, GSK reacted promptly and proactively to notify both FDA and doctors,” she told the jury.

“It went immediately to FDA. It immediately changed its label,” she said. “And it immediately sent out letters to doctors telling them about the changes.”

In his final summation, Tracey told the jury, “I want to talk to you about the Ingenix study because Ms. Varner said something that is very, very important.“

“She said when they found out what she says is August of 2005, within 21 days, they changed the label. Within 21 days, the doctors got the news,” he recounted.

What “she forgets to tell you is that two years prior to this, Anne Bell said, Don’t study the drug,” Tracey told the jury.

“Had they not listened to Anne Bell,” he said, “had they studied the drug in 2003, Michelle David wouldn’t be sitting here because the warning would have gone out like that.“

“We would have been two years ahead of the game,” he pointed out.

“GlaxoSmithKline did not want to study the drug,” Tracey told the jury. “The FDA made them study Paxil.”

“It was not some sort of voluntary we’re just a good drug company trying to get along,” he said. “It was we don’t want to study it and they’re forcing us to study it.”

Paxil Off-Label Promotion

Paxil is not FDA approved for use by pregnant women, so all mothers who gave birth to infants with heart defects received the drug off label. In Andy Vickery’s first case set for trial, Delaney Novak was born with heart defects after his mother, Laura, was prescribed Paxil for migraine headaches, another unapproved use.

Dr Dee Mangin is an expert witness in the Novak case. Her research and published work has focused on rational prescribing, and the influence of drug company promotion both to physicians and direct to consumers. She submitted a report on October 13, 2009, which outlines Glaxo’s off label promotion of Paxil around the time of Laura’s pregnancy.

In her report, Mangin defines off-label use as the “practice of prescribing drugs for a purpose outside the scope of a drug’s approved label – often an unproven use or one that has not been widely tested.”

“While it is legal to prescribe off label in the United States, it is illegal for companies to promote off label use,” she notes.

“The risks of off label promotion,” she says, “are that it could lead to exposure of patients to the risks of a medicine for no benefit, and furthermore they maybe denied other more effective treatment.”

“GlaxoSmithKline from 2000,” Mangin says, “mounted a multifaceted and targeted national promotional campaign that employed explicit strategies designed to promote sales of Paxil in pregnant women and women of reproductive age.”

An exhibit cited in the report from a “Paxil Tactical Marketing Plan in 2000,” states: “New Paxil data with high media interest, hot flash, postpartum, depression, pregnancy, and lactation will position Paxil as the drug of choice for women.”

“One of the known reasons that physicians change their prescribing behavior is as a response to the volume of evidence containing the same message that the physician is exposed to,” she wrote. “The so-called “Carpet Bombing” technique used in the Paxil campaign feeds directly into this.”

“There are a number of strategies companies can use to highlight use for off label conditions including distribution of individual scientific articles discussing the off label indication and use of the drug as well as mentions of off label use by key opinion leaders in continuing medical education,” the report explains.

“In relation to the off label prescribing for migraine,” Mangin says, “there is no evidence of any effectiveness over placebo for SSRIs in migraine prevention.”

Yet a paper titled, “Paroxetine in the Treatment of Chronic Daily Headache,” by Carol  Foster, MD, and Jacklyn Bafaloukos, RN, that was distributed to doctors, specifically states: “The dramatic improvement in the patients in our study suggests that paroxetine appears to be a safe and effective drug for the treatment of chronic daily headache.”

“The strategies outlined where reprints about treatment of migraine with paroxetine, large numbers of form letters containing summaries of studies of use in headache were sent to physicians and detailing and providing free samples to physicians likely to treat women with migraine were therefore encouraging use of Paxil and exposure to its risks when in reality it is no more effective in this situation than a sugar pill,” Mangin reports.

Encouragement “of unapproved use for migraine further attempted to expand the market beyond that which was medically justified and likely to lead to unnecessary exposure to the risks of Paxil,” she advises.

In an August 11, 2009 deposition, Laura’s doctor testified that Glaxo sales representatives would commonly leave reprints of articles on off label uses and salespeople did discuss the literature on the off label use of Paxil for migraines with him. One of the sales representatives visiting the doctor at the time stated in a deposition that it was his habit to distribute all such articles.

But most importantly, the doctor said he would not have prescribed Paxil to Laura had Glaxo told him back in 2000, or early 2001, that there was an association between Paxil and birth defects. He further noted that there was no benefit from Paxil that would outweigh the risks of birth defects and that he had not used Paxil in his practice since the Dear Doctor letter warned about birth defects.

Delaney suffers from a septal heart defect. “None of the information from the medical records of the family or their statements on potential genetic, environmental and pharmaceutical causes of heart defects indicates any other factor more likely to have caused her condition than the Paxil exposure,” Mangin points out.

“It is clear that if the prescribing doctor had been informed of the risk of heart defects, Laura Novak would not have been exposed to Paxil,” she notes.

In the report’s conclusion, Mangin states: “It is my opinion that this promotional campaign for Paxil was inappropriate given the scientific knowledge and what was known by the company at the time.”

“The degree of comfort with the use of this medication in the reproductive years and pregnancy is likely to be influenced by GSK’s misleading promotional campaign where concerns were minimized, efficacy was overstated, the idea of off label prescribing was seeded for migraine, and lastly the marketing specifically targeted a group at higher risk in terms of safety concerns – pregnant women and women in the reproductive age group,” she reports.

“This Paxil promotional campaign was irresponsible, and potentially disastrous from a public health perspective as it was likely to expose a much greater proportion of the population to these potential harms,” she concludes.

Glaxo’s Phone Book

During closing arguments on October 8, 2009, Tracey told the jury regarding Glaxo: “They have a telephone book full of doctors.”

Referring to an exhibit introduced during the trial, he said: “This is all the doctors that they pay to give speeches on their behalf to push their drug, to sell it, to convince other doctors to prescribe their drug.“

While Healy was testifying, Tracey had him go over some of names of doctors in the book that included Lori Altshuler, Vivian Burt, Lee Cohen, Charles Nemeroff, Jeffrey Newport, Zachary Stowe, Katherine Wisner and Kimberly Yonkers.  None of these doctors appeared to testify on Glaxo’s behalf in the trial.

What “they did was aggressively market this drug to women,” Tracey told the jury.

All “these names of people that they ghost-wrote articles for to get the doctors … to sell the drug,” he noted.

Doctor Healy told you that “they altered the prescribing practices in this country,” he recounted. “What they set out to do, they succeeded in doing. They got doctors to prescribe the drug to women.”

“And they did it,” Tracey said, “by having seminars where they would put these doctors, experts in the field, on their payroll, that the doctors would go and listen to, unwittingly knowing what they are really hearing is a marketing campaign.”

In reference to another exhibit viewed during the trial, Tracy said: “This document describes that it worked. When the doctors came out, these are the comments they made after attending these seminars: Will prescribe Paxil to pregnant women. My comfort in treating depression in pregnancy has increased. Treating pregnant patients with confidence. Will feel more comfortable giving Paxil to pregnant women.”

In citing $765 million in the US alone, between 1997 and 2005, Tracey told the jury: “This is the number for over a nine-year period this company spent to convince doctors to sell their drug, to prescribe their drug to women of childbearing years.”

“And they got a heck of a return on it,” he said. “Net. After expenses. Almost 14 billion dollars for a nine-year period.”

“Out of the 700 million dollars they spent trying to sell this drug to people,” Tracey stated, “there is not one shred of evidence in the record about how much money they spent to try to figure out whether it was going to induce birth defects.”

“And as far as I can tell in the record,” he said, “after they bought it, they did one animal study and they didn’t spend another penny.”

Evelyn Pringle

(The Paxil Birth Defect Litigation Update Series is sponsored by the Houston law firm of Vickery, Waldner and Mallia at http://www.justiceseekers.com )

(Evelyn Pringle is an investigative Journalist and Researcher focused on exposing corruption in government and corporate America)

Filed under: antidepressants, lawsuits, Paxil, paxil birth defects, Paxil birth defects trial, Paxil in pregnancy, Pregnancy, suicide, Withdrawal, ,

What the Media Doesn’t Say about Antidepressants & Pregnancy

In reality, you cannot separate the need for the baby to be healthy and to survive from the mother’s mental state. How many mothers honestly do not worry that something could go wrong with their babies or do not feel responsible for protecting their children? How many women who lost children can go on day by day not feeling anything about that loss? Which antidepressant are you supposed to take to help with depression if you’re dealing with loss after your baby dies from an antidepressant?

Unlike Vogue Magazine or TIME, for some reason ABC has decided to promote more misinformation that will no doubt prove deadly for far too many babies, and possibly mothers too. Read on to find out more…

You may have read a couple of posts I recently wrote (see: here – AMA Review: Antidepressants Pose Significant Risk of Serious Harm to Babies and here – ABC Story on ACOG Release Refers Readers to momsandmeds.com and CHAADA) after I was contacted for a possible story on TV by an ABC producer regarding the ACOG / APA guidelines on antidepressants and pregnancy.

As I wrote in those articles, I had sent numerous emails to the producer with various studies and analyses including not only the conflicts of interest (the conflicts document was so extensive that it took up about 20 pages or so in Word and I didn’t even look up all the names) among the researchers either writing or cited in the report, but also a comparison of the difference between the ABC article they published, and the actual report issued by the ACOG and APA.

I don’t expect that I’ll be hearing much back from them, but the reason I am writing this is not because I really wanted to be on TV (far from it) but because it just makes me horrified that the media can take something that says there is evidence of harm to babies (to quote the ACOG release, “[T]he use of antidepressant medications during pregnancy have been associated with negative consequences for the newborn…some studies have linked fetal malformations, cardiac defects, pulmonary hypertension, and reduced birth weight to antidepressant use during pregnancy.”) and twist it around by quoting “experts” with fancy titles who are willing to say that “the jury is still out” on whether antidepressants can hurt babies. The proposition is that it’s the depression that causes the birth defects, not the drugs.

The ACOG report clearly says that there is evidence of harm – but unfortunately when you watch the videos put out or read the articles on the ABCnews.com website you won’t know that unless you look further.

Just think about cases in which mothers who lose babies to antidepressants or have babies with severe birth defects linked to antidepressants go on to have more children off of antidepressants, without further problems in the babies. Julie Edgington is one example (out of 5 children, only one baby had problems and it was the one exposed to Paxil, Manie, her 4th), Kelly S., who lost her baby to a Paxil heart defect, is another. I was myself told that I shouldn’t have more kids because I would risk severe PPD. I had nothing of the sort. Toby is one of the healthiest kids I’ve seen. I know I am not the best example because I wasn’t actually depressed during pregnancy (was never depressed except for when I was taking Zoloft while nursing), but it just goes to show that there is no conscience regarding the harm coming to babies from these drugs. I was told to stay on Zoloft if I ever did want to have another baby. I am so thankful that Toby is drug-free and healthy.

I honestly do not know how these people can live with themselves.

A great example of what the public sees if they are not up on the latest information, but just passively receiving news bytes, is the ABC piece that just came out which covers Heather Armstrong’s story and states that there is no convincing proof that antidepressants cause harm to the baby. In it Heather tells ABC that she went off her meds during her last pregnancy but experienced panic attacks, and then later, suicidal thoughts after her baby was born, so she decided to stay on it during this recent pregnancy.

1) Of course when you go off antidepressants you can experience panic attacks or even suicidal thoughts – it’s called withdrawal. Been there, done that. For me the withdrawal was way worse than being on the drug at a stable dose, but once I got off of the drug and had time for it to clear out of my system I felt so much better.

Even if you were suicidally depressed before ever taking antidepressants, that does not mean that antidepressants will cure the suicidal thoughts, nor does it mean that you cannot find safe and effective alternatives (link to postpartum nutrition / orthomolecular medicine article). (See also: Preventing & Treating Emotional Problems and a post about counseling and self help.)

Perhaps Prozac really helped Heather feel better mentally but that does not justify what could have happened to the baby. During her last pregnancy she says that she had panic attacks. I think I’ll take panic attacks over my baby dying. It wasn’t even until after her baby was born that she says she had suicidal thoughts. So, were those a result of a drug withdrawal, or did she have a hormonal imbalance after birth of estrogen or thyroid that so many women have? I can’t claim to know what caused Heather Armstrong’s depression after her birth of her first child, but I can guarantee that it was not a Prozac deficiency and that there are safe treatments available. However it still makes no sense to me why having PPD would lead someone to consciously decide to take drugs during a subsequent pregnancy. If you had PPD before, then by all means if you are going to take drugs for PPD, do so after the baby is born and don’t do it while nursing. The time it takes you to get your placebo effect should be well worth it considering the peace of mind and increased safety for the baby.

In my opinion the reason women do this sort of thing stems from the misinformation fed to them by their doctors or other people in the public doing the off label marketing spin. Off-label marketing, or promoting psychiatric drugs to pregnant women (no psychiatric drug is FDA approved for pregnancy), by the way, is currently illegal, but the drug companies usually find ways to get others to do it for them. That’s more than I can say for Pfizer’s criminal behavior with the illegal marketing of Geodon and Lyrica.

2) Just because Heather Armstrong’s baby was born without complications (and she had an unmedicated birth if I am not mistaken) does not mean that the drugs are safe. Nor does it mean that whatever drug she is feeding her daughter in her breast milk is safe for the baby. I am so thankful that her daughter is ok so far, because no baby deserves to suffer from these drugs and I truly hope that she continues to be ok.

But this does not excuse pushing drugs on the entire country with misleading information from conflicted “researchers.”

Here is what you will probably not see on ABC any time soon:

(I hope ABC will prove me wrong, but so far no such luck)

Craniosynostosis caused by Antidepressant Exposure

Craniosynostosis before / after surgery (caused by antidepressant exposure)

Omphalocele caused by antidepressant exposure

Omphalocele caused by antidepressant exposure

Anencephaly (lack of forebrain) caused by antidepressant exposure - 100% fatal

Anencephaly (lack of forebrain) caused by antidepressant exposure - 100% fatal

Look at these devastating photos and ask yourself if it is really worth it to expose your baby to something that can cause a birth defect like this, when there is no taking back the exposure. I lived through suicidal and homicidal thoughts for four months because of Zoloft and I would not want to live through that again, but I would rather go through it (drug-induced or not) a hundred more times rather than have to live through losing a baby or having a baby born with a severe birth defect.

Everyone is bound to go through sad times, depression, grief and despair at some point in their lives but that does not mean that the entire human population suffers from serotonin deficiencies (when in reality serotonin excess is what leads to problems in the first place) or “chemical imbalances.”

I enjoy occasionally drinking wine or mixed drinks, but that doesn’t mean that because I feel relaxed while drinking alcohol, that I should drink when pregnant or that I suffer from an alcohol imbalance.

Women deserve to know the truth about what can happen with these drugs. They deserve to get the truth about what is causing their emotional problems (not some sales tactic like attributing it to an unproven, unprovable chemical imbalance) and how to safely deal with them with “alternative” medicine, orthomolecular medicine, proven hormone therapy, counseling, etc. They deserve support and understanding and compassion. They do not deserve to be fed deadly lies. But mostly, their babies deserve for the mothers to know.

ABC quotes doctors who say you cannot separate the health of the child from the health of the pregnant mother. This is an illogical catch phrase that they use in order to try and make us feel guilty for insisting on drug free options because some women obviously already take antidepressants and find it impossible to stop (again, this is caused by horrific withdrawal and the drug companies seem fine with that). Try and think about what this really means. They are saying that the mother’s mental health cannot be ignored during pregnancy because doing so hurts the baby. They are saying depression is more dangerous than drugs to the baby. Aside from the fact that this is clearly untrue, and that antidepressants do not reduce birth defects, but rather, increase them, think about whether you have ever been sad during pregnancy. Does feeling sad during pregnancy or being depressed cause PPHN, cardiac defects, the lack of a forebrain, and stillbirth? Or do toxic drugs with mystery chemicals that dangerously elevate serotonin and affect the organ development of babies cause these problems?

Something most people don’t know is that Fen-phen which was taken off the market for heart and lung-related deaths is actually a serotonergic drug which was a chemical mirror image of an SSRI. As I have said repeatedly and will say again, when you have drugs leading to heart problems and PPH in adults, how could they possibly not hurt babies the same way or worse?

Even after considering the fact that antidepressants actually cause depression and suicide, and work about as well as a placebo, this catch phrase makes about as much sense to me as saying that a mom who is addicted to crack, or drinks 5 coffees a day, or smokes, or is an alcoholic, should be told to keep doing those things if it eases her anxiety or fatigue while pregnant. Or about as much sense as telling women to go take Thalidomide because we’re not really sure that Thalidomide causes problems and it was probably actually the morning sickness causing the birth defects and not the Thalidomide. The jury is still out on whether swallowing RAID or drinking bleach while pregnant is bad for your baby. Perhaps working in a nuclear plant or handling plutonium should be considered safe for pregnant women too.

In reality, you cannot separate the need for the baby to be healthy and to survive from the mother’s mental state. How many mothers honestly do not worry that something could go wrong with their babies or do not feel responsible for protecting their children? How many women who lost children can go on day by day not feeling anything about that loss? Which antidepressant are you supposed to take to help with depression if you’re dealing with loss after your baby dies from an antidepressant?

Stop lying to women about what are confirmed, known risks.

If the jury were still out, the FDA would not be issuing warnings like:

“Infants born to mothers who took SSRIs after the 20th week of pregnancy were 6 times more likely to have persistent pulmonary hypertension (PPHN) than infants born to mothers who did not take antidepressants during pregnancy.”

See: PPHN Paxil baby Sarah Hart here. Sarah survived, but Matthew did not.
Face to Face:
http://www.flickr.com/groups/madnapfacetoface/

See more FDA MedWatch Data here: http://www.cchrint.org/psychdrugdangers/MothersAct.html

I can only hope that every person responsible for off-label marketing will be held accountable in some way. I am no expert in FDA  or criminal law, but when you essentially have money laundering taking place – drug companies giving donations to organizations, who then promote drugs through their own organizations via blogs, press releases, and speeches, it would seem that either the drug companies, or the individuals doing the marketing should be held to account for the off label promotions.


Warnings/Studies Showing Risks Associated with Antidepressants and Pregnant Women or New Mothers:

There is ample evidence to support the risks associated with placing pregnant women or new mothers on antidepressant drugs:

  • September 7, 2005: The Australian Therapeutic Goods Administration issued an information sheet to health professionals warning that SSRI antidepressant use—especially Paxil—in early pregnancy could cause congenital [defect at birth] heart abnormalities in newborns.[i]
  • September 27, 2005: The FDA and GlaxoSmithKline issued a warning that pregnant women taking Paxil or other antidepressants during their first trimester of pregnancy, placed their newborns at increased risk of major congenital and cardiovascular [heart] malformations at birth.[ii]
  • February 9, 2006: The New England Journal of Medicine found that mothers who took SSRI antidepressants in the second half of their pregnancies were 6 times more likely to give birth to infants with a lung disorder called persistent pulmonary hypertension (PPHN). The condition occurs when a newborn’s circulation system does not adapt to breathing outside the womb and causes high pressure in the blood vessels of the lungs making them unable to get enough oxygen into their bloodstream and can be fatal. Between 10% and 20% of infants with PPHN would die even if they receive treatment.[iii]
  • March 10, 2006: Based on the New England Journal of Medicine study, Health Canada issued a warning that SSRI antidepressants and other newer antidepressants when taken by pregnant women placed newborns at risk of developing the rare lung condition; persistent pulmonary hypertension or PPHN.[iv]
  • April 7, 2006: A Canadian study from the University of Ottawa published by the American Journal of Obstetrics and Gynecology, found pregnant women who used SSRI antidepressants were more likely to have premature and low birth weight babies.[v]
  • June 2006: An Archives of General Psychiatry study found women who take antidepressants during pregnancy at risk of giving birth to children with respiratory problems.[vi]
  • July 19, 2006: The FDA warned of the risk of a fatal lung condition in newborns whose mothers took SSRIs during pregnancy. The agency added it was seeking more information about persistent pulmonary hypertension in newborns from the drugs. It asked drug makers to list the potential risk on their drug labels.[vii]
  • November 2006: The journal Epidemiology published a study entitled “Maternal Use of Selective Serotonin Reuptake Inhibitors and Risk of Congenital Malformations.” Researchers did the study from Aarhus University. It found that pregnant women who take SSRI antidepressants are more likely to have babies with birth defects than mothers who don’t take these drugs.[viii]
  • August 2007: The American Journal of Psychiatry published a study that determined that antidepressant use during pregnancy was associated with premature births.[ix]
  • September 18, 2007: A study published in the Annals of Internal Medicine of nearly 500,000 women by researchers at the University of Pittsburgh Medical Center found that nearly 50% of women taking a prescription drug that could cause birth defects did not receive warnings to avoid pregnancy.
  • Moreover, experts say the seriousness of a life-threatening lung disorder found six times more often in infants born to mothers who take antidepressants during pregnancy is not being adequately conveyed to women while they are considering whether to use the drugs.[x]
  • The Physicians’ Desk Reference (PDR) states: “Like many other drugs, paroxetine [chemical name for the antidepressant Paxil] is secreted in human milk, and caution should be exercised when Paxil…is administered to a nursing woman.”

Selected SSRI Antidepressant Studies/Warnings on Suicide Since 2001:

  • March 22, 2004: The FDA warned that SSRIs could cause “anxiety, agitation, panic attacks, insomnia, irritability, hostility, impulsivity, akathisia [severe restlessness], hypomania [abnormal excitement] and mania [psychosis characterized by exalted feelings, delusions of grandeur].”
  • February 18, 2005: A study conducted at the Ottawa Health Research Institute and published in the British Medical Journal determined that adults taking SSRI antidepressants were more than twice as likely to attempt suicide as patients given placebo.[xi]
  • June 30, 2005: The FDA issued a Public Health Advisory entitled “Suicidality in Adults Being Treated with Antidepressant Medications,” that there could be an increased risk of suicidal behavior in adults taking antidepressants. It recommended that physicians monitor adults who took antidepressants for suicidal tendencies.[xii]
  • August 4, 2005: The Australian Therapeutic Goods Administration published an Adverse Drug Reactions Bulletin reporting evidence supporting an association between SSRI use and “new onset of suicidality” in adults.[xiii]

[i] “Information for health professionals concerning the use of SSRI antidepressants in pregnant women,” Australian Therapeutic Goods Administration,” 7 Sept. 2005.[ii] “Important Prescribing Information,” Letter to healthcare professionals by GlaxoSmithKline, Sept. 2005; Miranda Hitti, “New Study Links Paxil to Twice as Many Birth Defects as Other Antidepressants,” WebMD Medical News, 27 Sept. 2005.[iii] Christina D. Chambers, Ph.D., M.P.H., Sonia Hernandez-Diaz, M.D., Dr.P.H., Linda J. Van Marter, M.D., M.P.H., Martha M. Werler, Sc.D., Carol Louik, Sc.D., Kenneth Lyons Jones, M.D., and Allen A. Mitchell, M.D., “Selective Serotonin-Reuptake Inhibitors and Risk of Persistent Pulmonary Hypertension of the Newborn,” New England Journal of Medicine, Vol. 354, 2006, pp. 579-587.

 

[iv] Health Canada Advisory, “Newer antidepressants linked to serious lung disorder in newborns,” 10 Mar. 2006.

[v] Andre Pickard, “Prozac-type drugs increase birth risks, study finds,” Globe and Mail, 4 June 2006.

[vi] Tim F. Oberlander, M.D., FRCPC; William Warburton, Ph.D.; Shaila Misri, M.D., FRCPC; Jaafar Aghajanian, B.Sc.; Clyde Hertzman, M.Sc., M.D., FRCPC, “Neonatal Outcomes After Prenatal Exposure to Selective Serotonin Reuptake Inhibitor Antidepressants and Maternal Depression Using Population-Based Linked Health Data, Archives of General Psychiatry, Vol. 63, 2006, pp. 898-906.

[vii] “Antidepressants should list new risks: FDA,” Reuters, 19 July 2006.

[viii] Wogelius, Pia, Nørgaard, Mette, Gislum, Mette, Pedersen, Lars, Munk, Estrid, et.al. “Maternal Use of Selective Serotonin Reuptake Inhibitors and Risk of Congenital Malformations,” Epidemiology, Vol. 17, No. 6, Nov. 2006.

[ix] Rita Suri, M.D., Lori Altshuler, M.D., Gerhard Hellemann, Ph.D., Vivien K. Burt, M.D., Ph.D., Ana Aquino, B.S., Jim Mintz, Ph.D., “Effects of Antenatal Depression and Antidepressant Treatment on Gestational Age at Birth and Risk of Preterm Birth,” American Journal of Psychiatry, Vol. 164, Aug. 2007, pp. 1206-1213.

[x] Evelyn Pringle, “Women not warned about SSRI-related lung birth defect,” Countercurrents.org, 2 October 2007.

[xi] “Drugs Raise Risk of Suicide; Analysis of Data Adds to Concerns on Antidepressants,” The Washington Post, 18 Feb. 2005.

[xii] “Suicidality in Adults Being Treated with Antidepressant Medications,” FDA Public Health Advisory, 30 June 2004.

[xiii] “Suicidality with SSRIs: adults and children,” The Australian Therapeutic Goods Administration (TGA) Adverse Drug Reactions Bulletin, Vol 24, No. 4, Aug. 2005, p. 14.

Filed under: antidepressants, Baby Matthew, Birth Defects, child endangerment, Christian Delahunty, Christiane Schultz, dead babies, Effexor, Effexor in pregnancy, FDA Warnings, Indiana, Informed Consent, Isaac Philo, Julie Edgington, Paxil in pregnancy, PPD, Pregnancy, toxicity deaths, Withdrawal, Wyeth, Zoloft, , , ,

Another Close Call Converts Mom to Activist

The following is via email from one new member of MADNAP – check it out on the BREATH blog:

http://momsandmeds.wordpress.com/2009/04/19/an-amazing-ssri-survivor-story-of-one-madnap-member/

Filed under: antidepressants, Withdrawal, , , , ,

Teen Plans Columbine Copycat Massacre After Use of Bipolar Meds

Paragraph 7 reads:  “Doelitsch said that he had been depressed and that his mother had taken him off his bipolar medication because she was afraid he would suffer from other health problems later. The teen is back on the medication and is seeing a psychiatrist.”

The danger of withdrawal from antidepressants and antipsychotics is well documented.  The brain tries to compensate for the blockage of the serotonin and dopamine receptors by growing additional receptors for these neurotransmitters.  When the medications are discontinued, these additional receptors contribute to an ‘overload’ of serotonin and dopamine flooding the receptor. This is known as “supersensitivity psychosis” & antidepressant  discontinuation syndrome .  An explanation for both antidepressant withdrawal and antipsychotic Supersensitivity Psychosis caused by withdrawal can be found here.

Rosie Meyenburg:  Moderator:  SSRI Stories

http://www.ksat.com/news/17321947/detail.html

“Teen Accused Of Plotting School Attack Blames Threats On Depression 
Allen Doelitsch Planned Attack On Boerne Champion High School, Police Say

POSTED: 7:53 am CDT August 28, 2008
UPDATED: 8:24 am CDT August 28, 2008

BOERNE, Texas – An 18-year-old Boerne man charged in plotting an attack at Champion High School blamed depression, being off his medication and a television program for the events that led to his arrest this week.

During a jailhouse interview Wednesday with KSAT 12 News, Allen Doelitsch admitted asking a 14-year-old friend to join him in a “Columbine-style” attack at Boerne’s newest high school on Monday.

But Doelitsch said he never would have following through on the threat. 

“It’s just what I thought about doing at the time,” he said. “I don’t feel like doing it all the time. I never said anything about doing it. I just said I felt like it. I didn’t say I was going to.”

Doelitsch added that it would have been difficult to have carried out the threat because he doesn’t own any weapons.

“I don’t have any guns at my house,” he said. “I really don’t want to hurt other people. There’s no point. They didn’t do anything to me, so why would I do anything to them?”

Doelitsch said that he had been depressed and that his mother had taken him off his bipolar medication because she was afraid he would suffer from other health problems later. The teen is back on the medication and is seeing a psychiatrist.

The teen, who was charged with criminal solicitation of a minor to commit capital murder, also blamed his thoughts after watching television programs about the Columbine Massacre.

“I started watching it and getting into it,” Doelitsch said.

Doelitsch remained in the Kendall County Jail on a $500,000 bond.”

Filed under: Columbine, Supersensitivity Psychosis, Withdrawal

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