You probably don’t know the name of William Seale.  William’s mother took the anti-depressant drug Paxil during her pregnancy.  William died in 2004 at only 1-year-old after three surgeries to correct heart defects.¹ And then there’s Lyam Kilker, now 3.  His mother also took Paxil when she was pregnant. Lyam was born with two holes in his heart and underwent multiple heart surgeries within 6 months of his birth.² Thankfully, he’s still alive.

The families of William and Lyam have brought the first of 600 cases against pharmaceutical giant, Glaxo Smith Kline (GSK) for its bestselling drug, Paxil, alleging that it causes birth defects when taken by pregnant women.  But that’s not the worst of it.  From evidence presented in court, the company knew of these risks and covered them up.

Here’s what we know so far.

As early as 1980 one of GSK’s scientists wrote in a memo to company executives that based on animal studies, the drug could cause birth defects when taken at higher levels.  Yet the company waited almost 20 years before it was willing to do further studies on why the test animals died.³ In fact, in 1997, a GSK executive wrote that if animal studies were to be conducted on Paxil, the company could “bury” any negative findings.⁴

Then in 1998, the company evaluated all the side effects of Paxil including reports of 50 miscarriages and in utero deaths up to 1997.  Although the company’s own scientists wrote in their report that these numbers were “alarmingly high,” GSK never turned the data over to the FDA as is required.  Instead, the report it submitted to the Agency pointedly left out these incriminating facts.⁴

And then there’s the e-mail that GSK received from a Paxil user in the UK in 2001.  The woman had aborted her fetus because of a heart defect.  After analyzing the e-mail, company officials wrote that they were “almost certain” that the drug was related to the heart problem.⁶ Still, they did nothing.

It wasn’t until 2005 when the FDA conducted its own research on the drug, that its link to birth defects, particularly to the heart of a developing fetus was made public.  Along with alerting physicians to the risk, the Agency required GSK to print the warning on the drug’s label.⁴

In effect, the company took no action at all to protect pregnant women and their unborn children until forced to do so by the government.

Here’s one more thing I’d like to share with you about the drug.  According to Dr. Lili Wagner, Paxil produces a powerful chemical dependency that causes most users to need it just to function normally.  The drug has caused serious withdrawal symptoms in some people that have tried to stop taking it.⁵ This may explain why many pregnant women did not automatically stop taking Paxil when they became pregnant — and why GSK had a responsibility to warn them of the risks before they became pregnant.

So the message here is this.  Whatever your age or gender, Paxil and other anti-depressants should only be taken as a last resort — with the realization that they have the potential for very dangerous side effects.  Using diet, exercise, stress reduction, and counseling is your best defense against depression and the powerful synthetic drugs that treat it.  Think of yourself and the kids.

References

1. http://www.newsinferno.com/archives/12325#more-12325.
2. www.druginjury.com.
3. http://www.bloomberg.com/apps/news?pid=20670001&sid=ae8Ie3hNoafw.
4. www.newsinferno.com/archives/12325#more-1235.
5. http://www.utahstories.com/chemical_imbalance_myth.htm.
6. http://fiddaman.blogspot.com/2009/09/glaxo-linked-birth-defect-of-fetus-to.html

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