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FDA Warns Of Risks With The Use Of Paxil – Birth Defects And Suicide

The side effects of Paxil have caused serious medical and psychological complications in some patients and have most recently been linked to birth defects and suicide. Please CLICK HERE for a free case evaluation.

Birth Defects

In December 2005, the U.S. Food and Drug Administration (FDA) issued a Safety Alert
advising healthcare professionals that exposure to Paxil (and the generic Paroxetine) in the first trimester of pregnancy may increase the risk for congenital birth defects especially cardiac birth defects. Most of the cardiac defects involved an underdeveloped wall between the left and right side of the heart. At the FDA’s request, Glaxo Smith Kline (the manufacturer of Paxil) has changed the pregnancy precaution of Paxil from C to D and updated the label to read that Paxil should only be used during pregnancy if the potential benefits outweigh the risk to the fetus.

The New England Journal of Medicine, published February 9, 2006, showed that babies born to mothers who took selective serotonin reuptake inhibitors (SSRI), antidepressants like Paxil, after the 20th week of pregnancy were 6 times more likely to have persistent pulmonary hypertension (PPHN) than those born to mothers who did not take an SSRI during pregnancy. In July 2006, the FDA issued a Safety Alert advising that pregnant women who are taking Paxil and other SSRIs could give birth to a baby with PPHN. Babies with PPHN have abnormal blood flow through the heart and lungs and do not get enough oxygen. This can cause babies to be very sick and die. The FDA updated information for all SSRIs with these findings. Some commonly used SSRIs are Celexa, Lexapro, Fluvoxamine, Paxil, Prozac and Zoloft.

Suicide

Some experts believe that the use of Paxil and other SSRIs can increase the risk of suicidal thoughts and behavior in children, adolescents and young adults. In 2004, the FDA called for a black box warning to be displayed on Paxil and other antidepressants, warning of an increase in suicide and violence in children and adolescents. In December 2006, an FDA federal panel called for the black box warning to extend to young adults. Glaxo Smith Kline, the makers of Paxil, concealed information from four studies that concluded the drug was ineffective in treating depression in young people and potentially increased the risk of suicidal thoughts.

Your Rights

Because the makers of Paxil have been accused of failing to warn the public of some of the dangers of taking Paxil, our attorneys are pursuing claims on behalf of clients who have been injured from the use of Paxil. A lawyer familiar with new developments in the investigation of Paxil may be able to help you make important personal and legal decisions and if needed file a Paxil lawsuit. Please CLICK HERE for a free consultation.

Breaking News:

FDA Advisory of Risk of Birth Defects with Paxil
http://www.fda.gov/bbs/topics/NEWS/2005/NEW01270.html

last updated 3/19/2007