Failure To Warn: Glaxo, Paxil & Pregnancies
18 CommentsBy Ed Silverman // June 26th, 2008 // 9:42 am
Much of the hoopla one reads about the controversial antidepressant concerns the risk of suicide and the extent to which the drugmaker disclosed - or did not disclose - meaningful clinical trial data. However, a pending lawsuit points up another issue - whether Glaxo adequately disclosed and investigated the risk of congenital abnormalities.
In an expert witness report written by Suzanne Parisian, an industry consultant who is a former FDA medical officer and US Public Health Service officer, the drugmaker is taken to task for failing to adequately design pre-clinical trials to detect cardiovascular effects; not including and later updating risk info for developing fetuses in the Paxil labeling; and failing to investigate indications of an association between first trimester Paxil use and congenital abnormalities.
One key example: Parisian cites a confidential Paxil memo showing a 13.3 percent rate of congential abnormalities through 1997, a figure that Glaxo managers acknowledged was higher than reported by birth-defect monitoring organizations and that represented a “significant finding.” You can read the full report here.
UPDATE: A Glaxo spokeswoman sent us this statement: “The company strongly disagrees with her conclusions and will file in the litigation its own expert witness reports rebutting these allegations. Glaxo has monitored reports of birth defects since the beginning, whether from the published literature or reports from doctors and patients. There was no indication of any increased risk from pre-clinical studies, clinical studies, adverse event reports or from the literature, until the summer of 2005.
“As soon as Glaxo became aware of a potential increased risk, it promptly notified FDA, informed physicians, worked with FDA to update the Paxil label, and undertook further investigation to better understand the possible increased risk.
“From 1996 to December 2005, the Paxil label stated that Paxil was Pregnancy Category C; animal studies revealed no evidence of teratogenic effects, but there was an increase in rat pup deaths; there were no adequate and well-controlled studies in pregnant women; and because animal studies are not always predictive of human response, Paxil should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
“In December 2005, Paxil became Pregnancy Category D, and a warning was added describing new epidemiological studies showing an increased risk, and stating that for women who intend to become pregnant or are in their first trimester of pregnancy, Paxil should only be initiated after consideration of the other available treatment options.”
truthman30
Many kids have been morn with Paxil induced birth defects..
There seems to have been an indication from GSK’s own original clinical trial data that Paxil was related to an increased rate of pup mortality in baby rats..
http://truthman30.wordpress.com/category/seroxat-link-10-paroxetine-womb/
http://bigpharmavictim.blogspot.com/2008/03/what-this-blog-is-about.html
What disturbs me about this, is the defects shown in baby rats and also now in human babies surely must indicate that Paxil is in fact dangerous and defective and unfit for use in the general population…
truthman30
Many kids have been born with Paxil induced birth defects..
There seems to have been an indication from GSK’s own original clinical trial data that Paxil was related to an increased rate of pup mortality in baby rats..
http://truthman30.wordpress.com/category/seroxat-link-10-paroxetine-womb/
http://bigpharmavictim.blogspot.com/2008/03/what-this-blog-is-about.html
What disturbs me about this, is the defects shown in baby rats and also now in human babies surely must indicate that Paxil is in fact dangerous and defective and unfit for use in the general population…
Julie(Manie's Mom)
I believe GSK was finally forced to turn over documents showing they knew about Paxil and birth defects as early as 92.
92 would have been 11 years before I became pregnant with my son Manie.
Read Manie’s Story at http://www.bigpharmavictim.blogspot.com
Ben Hansen
Look at the image of a pregnant woman, with the slogan, “Your life is waiting,” at GlaxoSmithKline’s Paxil CR product web site:
http://www.paxilcr.com/
http://www.paxilcr.com/images/common/headerwhite.jpg
I wonder how long before GSK removes this image from Paxil promotional material?
Ellen Liversidge
Dear Julie, I saw Manie’s youtube on Amy Philo’s website and it, along with her story, made me decide to do what I could to get S. 3175 off the radar screen in the Senate. If enacted, it will result in more damage and death - something we all have had too much of with psychotropic drugs.
Good luck with your efforts, and with your sweet boy.
Lisa Van S
Paxil,.. Category D.!! That says it all. GSK the drugmaker who loves to harm Infants,.. Toddlers,.. Children,.. and Adolescents. Real Bad Publicity,..just like a bad rash, Am I correct Ms. Rhyne?..
Sam
See http://www.psychdrugdangers.com/MothersAct.html which documents the reports sent to the FDA between 2004 and 2007 of adverse reactions experienced by expectant and new mothers and their babies (when the survived) taking SSRIs and other psychiatric medications while they were pregnant and while breast feeding. Paroxetine (Paxil, Seroxat, etc) is the worst with 65 Spontaneous Abortions (miscarriages) attributed to the drug among a long list of other adverse reactions including Transposition of the Great Vessels which is what struck Manie and at least 28 other babies.
And it is simply not true that Glaxo was not aware of these adverse reactions before the summer of 2005. The report codes - which list the type of report - have been added to the MothersAct Paroxetine table (if you’ve seen it before) where EXP is an Expedited (15 day) report sent from Glaxo to the FDA, PER is a Periodic report sent from Glaxo to the FDA, DIR is a Direct report from the consumer or observer (physician, pharmacist, etc) to the FDA which Glaxo may not have been aware of. It can clearly be seen that EXP report after EXP report (sent by Glaxo to the FDA) with Event Dates in 2003 and 2004 were submitted and received by the FDA in 2004 (including some with no Event Date reported, but received by the FDA in early 2004).
The reports in this table are from the FDA’s 2004-2007 reporting period, therefore January 2004 is the earliest date the FDA received a report shown in this table.
However, a separate report on paroxetine adverse reactions that have not been incorporated into this table was obtained by an FOIA request and lists numerous EXP reports starting in early November of 1997 when the manufacturer was SmithKline Beecham (which merged with Glaxo Wellcome in 2000 to become GlaxoSmithKline or GSK) including several Suicide Attempts in the adverse events reported.
Brief examination of this document (which includes 30,976 reports, some of which are in the MothersAct table) found at least one EXP report (that’s all that was checked for) for each year from 1997 to 2003.
Sam
Oh, and in that FOIA report are numerous “congenital …” (birth defects) adverse reactions:
Congenital Central Nervous System Anomaly, EXP of 11/13/97 with Seroxat (paroxetine) as the Primary Suspect Drug (PS)
Atrial Septal Defect, Heart Disease Congenital, Patent Ductus Arteriosus and Ventricular Septal Defect Acquired, EXP of 6/24/98 with Aropax (paroxetine) as the PS
Congenital Absence of Bile Ducts, EXP of 7/27/98 with Paroxetine as the PS
Complications of Maternal Exposure to Therapeutic Drugs, Congenital Foot Malformation, Corneal Opacity Congenital and External Ear Disorder, EXP of 5/13/99 with Seroxat as the PS
Complications of Maternal Exposure to Therapeutic Drugs, Congenital Foot Malformation, EXP of 6/25/99 with Paroxetine as the PS
etc …
And there are 171 reports which include Abortion Spontaneous (miscarriage) in the adverse reactions beginning 1/21/98 through 11/14/03. There is one DIRect report in this lot and a few PERiodic; the rest are EXPedited (from SKB or GSK to the FDA). (A thorough examination of these miscarriage reports was not done, so there may be a few that are on the same Case.)
truthman30
What really saddens me about this whole thing is..
I really feel that Pharmaceutical companies know these drugs cause this damage and they know the truth eventually comes out some time in the future, but they consider it a viable option because they know the pittance they eventually might pay out on lawsuits will never even dent the profits they make on the life time of the drug. This seems to have become standard pharma practice now, and i think that it a really really tragic state of affairs for all consumers..
And also what amazes me is the individuals in these pharma corporations, the CEO’s and Executives who make the decisions , they all know this is going on, how can they live with themselves? And do they not realize that by encouraging a culture of suppressing bad data could affect someone they know, their loved ones or even themselves in the future, it really is truly beyond comprehension, the lengths some people will go to make a living.. Do they think they are immortal and immune? Do they think it couldn’t happen to them?
Or in the case of a lot within pharma nowadays ..
“they make their living off killing”…
the drugs industry should never be permitted to behave like used car salesmen, but thats what it amounts to nowadays…
There is an article about Ford from 2000 , apparently it also knew a model of its car was defective yet continued to sell it, suppressing data for years, you know the usual story.. it is very interesting , because I believe this has become the standard business practice within pharma.. unfortunately the stakes are higher with drugs than with cars…
http://query.nytimes.com/gst/fullpage.html?res=9502EFD91638F931A2575AC0A9669C8B63&sec=&spon=&pagewanted=all
Vince
What little accountability there is in this industry will descend even further if the principle of preemption takes root. Imagine where that will take us.
Sabine Bowles
I am a 42 year old woman who took an SSRI before and through the entire pregnancy with my now almost 5 year old daughter. She was born with a congenitial heart defect called Tetralogy of Fallot. I have two older children 17 and 15 and they are perfect but during their pregnancy at that time was even scared to drink a sip of caffeine. There is no doubt in my mind the SSRI caused my daughter’s heart issues and the Pharmaceutical Industry was and is completely aware of it.
HorusCat
So what’s the story with the non-paroxetine SSRIs? Since only Paxil got the PC D rating…
I know when we got questions about Zoloft and pregnancy we punted and told the docs, “No data, can’t do studies, there is a registry, only you and the patient can make that kind of decision, the risks of not-treating have to be very great, talk to the OB, contact our Medical Affairs office…” In other words, WE aren’t going to tell you it’s ok…we don’t need the business that badly.
Shelly Hart
Its no secret that my daughter was born and was almost lost to Paxil. My Paxil dose was actually INCREASED when I was pregnant in the first semester (to avoid weepiness) If any one wants to share their story, contact Amy Philo at Madnap or myself at hart.shelly@yahoo.com. Amy is writing a chapter in my book about Paxil withdrawal/babies
Jaynesday
Truthman,
It’s true that there have been other cases where a company knew that their product was faulty but continued to produce. They got caught and were severely punished. But here’s the key point - after they were caught and punished they revised their way of doing business and in the end continued on with a much better product. Lessons were learned and ultimately the consumer was given a product that was safer. The cost of the product did not increase to an unacceptable level.
But now you have the pharma industry picking up the preemption crutch because according to them, they can’t afford to make a quality product. Instead of lessons learned about how to improve the product you will see continual consumer harm and a stringing out of disasters until the consumer eventually revolts. But in the mean-time many will lose their life and health.
truthman30
“But now you have the pharma industry picking up the preemption crutch because according to them, they can’t afford to make a quality product. Instead of lessons learned about how to improve the product you will see continual consumer harm and a stringing out of disasters until the consumer eventually revolts. But in the mean-time many will lose their life and health”
I know its is a diabolical situation…
Preemption is being used as a shield for the pharmaceutical industry and an axe and hatchet against consumer rights..
Justice in Michigan
Jaynesday writes: “They got caught and were severely punished. But here’s the key point - after they were caught and punished they revised their way of doing business and in the end continued on with a much better product. Lessons were learned …”
I devoutly with that were true, and I believe it is in some instances. In other instances, however, the consequences were relatively minor and easy to file under “cost of doing business.” For example, Warner Lambert was (in my view and the view of some of their own scientific team) pushing fudged Rezulin data more or less at the same time the Neurontin scam was beginning to unravel. Stock price continued to soar. And Pfizer was more than willing to buy them (in hostile take-over), given that they got Lipitor as part of the deal.
I also believe there are instances where the King of Torts is a real beast. I know of instances where industry people were prepared to speak out against illicit company practices but refrained because of the wider unfairness of a suit itself. I don’t blame them.
So it ain’t simple. We need multi-faceted policy solutions that best balance the claims of patients, industry, FDA, et. al. - that is, that minimize exploitation on several sides.
Essy to say!
Jaynesday
JiM,
Sorry my post was confusing, I was referring to Truthman’s comment about Ford Motor Company and other auto manufacturers that have hidden critical defects. Mitsubishi Motors was almost destroyed by hiding quality defects in Japan about 6 years ago.
They have just now begun to post a profit.
The point is that in other industries failures have led to improved ways of doing business and corporate responsibility. Pharma has chosen another path to the peril of all of us.
Amy Philo
Stories like this highlight the danger of programs to push drugs on women… particularly pregnant, and postpartum women who are at a high risk of becoming pregnant…
See: http://www.uniteforlife.org re: The (Drug The) MOTHERS Act…