For several years, GlaxoSmithKline P.L.C. ignored evidence that its antidepressant, Paxil, may have caused birth defects in Missouri and throughout the nation, according to details emerging from a pharmaceutical liability lawsuit. The claim was filed by a woman who says her 3-year-old son has heart problems because she took Paxil during her pregnancy. Attorneys nationwide who have filed these Paxil lawsuits on behalf of injured clients and their children are alleging that Glaxo, for many years, knew about early tests and research results which all raised issues of concern. In fact, an attorney cited a test where rats that were administered Paxil were more likely to have pups that did not survive past four days.
Warnings relating to Paxil apparently came as early as the 1980s. A scientist warned in an internal memo that "there remains the possibility" that Paxil could cause birth defects in higher doses. But Glaxo ignored those research findings. There are now 600 or more pending cases in the United States, which allege that Glaxo knowingly put Paxil on the market and concealed its risks from consumers in order to boost profits. Paxil, which was approved by the U.S. Food and Drug Administration (FDA) in 1992, generated $942 million in sales just in 2008. Attorneys for Glaxo have denied all allegations and maintain that Paxil has cleared all clinical trials.
Statistics show otherwise. By 1997, within five years of Paxil's approval, Glaxo had received reports of 50 miscarriages or intrauterine deaths. A Glaxo scientist at that point warned that the high number of cases was "an alarming finding." That warning was also ignored by the pharmaceutical company and went unreported to the FDA.