Paxil Birth Defect Trial Set to Start

Much has been written about side effects linked to the antidepressant drug <"">Paxil (generic: paroxetine), including that it can lead to birth defects. Now, drug maker giant and maker of Paxil, GlaxoSmithKline Plc, will have to defend itself in a Philadelphia court next week, reports The trial is believed to be what described as a “test case” for over 600 other cases in which Paxil has been blamed for birth defects. The judge in the Philadelphia cases denied Glaxo’s motion last month to bar punitive damages, said

Patients and their parents claim that internal Glaxo documents show the drug maker neglected to publicize warnings about Paxil’s risks until it was compelled to do so by the U.S. Food and Drug Administration (FDA) in 2005, said Paxil was approved by the agency in 1992.

The trial is set to begin September 14. Two other such trials are also scheduled in Philadelphia’s state court for later this year, according to Glaxo is also in lawsuits in the United States, Canada, and the United Kingdom over claims Paxil causes homicidal and suicidal behavior.

Last year, said, Paxil generated approximately $942 million in sales, which represents less than three percent of Glaxo’s total sales.

According to the FDA, in late 2005 it sent an alert to physicians about early studies suggesting Paxil could be a contributor to heart defects in babies when taken by expectant mothers in the first trimester, said The government asked Glaxo to update medication information warning on birth defects.

Plaintiff attorneys claim Glaxo’s paperwork prove it was aware Paxil could increase birth defect risks as far back as 1980 and that it did not fully research Paxil before—and after—release to market, said “There remains the possibility that this compound could be teratogenic at higher dose levels. A teratogenic agent is one that causes malformations of an embryo or fetus,” wrote company scientist John Baldwin in a 1980 memorandum, quoted

Plaintiff’s lawyers wrote, “In the face of this warning from Baldwin, GSK chose not to perform any additional animal studies to explore the teratogenic effects of Paxil,” reported Also, according to the report, in 1993, Glaxo destroyed raw data from animal studies; in 1996, 1998, and 2000, it withheld safety reports detailing adverse reactions in mothers who took Paxil; and in 1994, supported a low-dose study “as the best way forward and having an acceptably low risk of triggering adverse labeling worldwide,” citing meeting minutes.

In 2005, the FDA, citing a Swedish study, indicated a two percent increased risk of birth defects in infants whose mothers took Paxil in early pregnancy, two-fold higher than the general population, said The FDA noted that another study found the risk in Paxil users was 1.5 percent with one percent for those on other anti-depressants, said

As we have been reporting, some anti-depressants, including Paxil:

Are known to affect sexual functioning in men and women

Have been found, in men, to impair fertility, sperm, erectile function, and ejaculation

Might interfere with the efficacy of breast cancer medication, tamoxifen, leading to recurrence of breast cancer

Are linked to cardiac arrest in some studies; are linked to an increase in the risk for sudden cardiac death (SCD) in a study of women with no cardiac history; and are known to cause a number of cardiovascular side effects, such as irregular heart rhythms and potentially lethal arrhythmias, in some

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