When SmithKlineBeecham (now www.gsk.com) introduced its anti-depressant Paxil in 1992, the United States Food and Drug Administration www.fda.gov classified it as a drug with no known links to increased birth defects. The FDA did so, based upon the representations of the manufacturer. However, a recent court trial for a baby damaged by Paxil showed that Glaxo learned long ago that a link existed. Glaxo was not forthcoming with that information but the court battle brought it to light.
Based upon that evidence, the jury ordered Glaxo to pay $2.5 million for a baby who was born with serious heart defects after his mother took Paxil during her pregnancy. The evidence showed what Glaxo knew and when it knew it.
Glaxo started getting reports of adverse events from patients and healthcare providers in the late 1990s. Although these reports should have alarmed Glaxo, it did not issue warnings. Finally the FDA required it to change its warning in 2005, based upon adverse events reports.
The warnings require that Glaxo notify patients and health care providers that Paxil may be associated with birth defects. Mothers who took it during pregnancy and whose children were born with heart malformations and other problems may now know why that happened.
There are about 600 cases like the recent trial. Now that the evidence is in the public record, we hope that these cases will result in justice all across America for mothers who took Paxil and whose babies were born with heart problems and other defects.