Paxil Manufacturer Sued
Monday, March 03, 2008
A woman recently filed a class-action lawsuit against the manufacturer of a frequently prescribed anti-depressant medication. The woman alleges drug company Glaxo-Smith-Kline didn't adequately warn of the potential side effects for pregnant women taking the drug Paxil.According to court documents, the woman says she was been prescribed Paxil during and after her pregnancy, and her daughter was born with cardiovascular birth defects. The suit alleges Glaxo-Smith-Kline failed to notify pregnant women about the risks associated with the drug and suggests the company targeted pregnant women, who are often susceptible to depression.
Paxil (generic: paroxetine), a selective serotonin reuptake inhibitor (SSRI antidepressant), was approved by the FDA in 1992. Paxil’s manufacturer, Glaxo Smith-Kline, released an internal study in 2005 which found a 1.5 times increased risk for heart malformations in infants whose mothers took Paxil while pregnant compared with other antidepressants. The normal risk of a newborn having a heart defect is about 1 %.
In December 2005, the FDA released a warning to women about the dangers of taking Paxil while pregnant. In November 2006, the American College of Obstetricians and Gynecologists warned women to avoid taking Paxil during pregnancy. Paxil has been lowered from Pregnancy Class C to Class D, signifying that studies in pregnant women demonstrate a risk to the fetus.
Posted in Dangerous Drugs • Paxil Birth Defects