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PAXIL

Paxil (paroxetine hydrochloride) is part of a family of drugs called selective serotonin re-uptake inhibitors (SSRIs). Paxil is sold as Seroxat outside of the United States. With too little serotonin, people tend to harbor negative feelings about themselves and everyone around them. SSRIs such as Paxil keep serotonin circulating in the body longer and help to alleviate the symptoms of clinical depression, anxiety and other manifestations of low serotonin levels.

Paxil is prescribed for a variety of illnesses including generalized anxiety disorder, social anxiety disorder, obsessive-compulsive disorder, and depression. Recently, GlaxoSmithKline PLC applied to the Food & Drug Administration for permission to market Paxil as an effective treatment for acute social phobia, an extreme form of shyness.

In September 2005, the FDA issued a warning detailing the results of a study that linked Paxil to birth defects. An increased number of women taking Paxil during the first trimester of pregnancy, compared with women using other antidepressants, reportedly had babies born with birth defects, including heart problems.

The FDA has determined that exposure to paroxetine in the first trimester of pregnancy may increase the risk for congenital malformations, particularly cardiac malformations. At the FDA's request, the manufacturer has changed paroxetine's pregnancy category from C to D and added new data and recommendations to the WARNINGS section of paroxetine's prescribing information. FDA is awaiting the final results of the recent studies and accruing additional data related to the use of paroxetine in pregnancy in order to better characterize the risk for congenital malformations associated with paroxetine.

See your doctor if you have experienced serious health problems after taking Paxil. In addition, it may be important to contact a paxil attorney who can help you protect your legal rights. Please keep in mind that there may be time limits within which you must commence suit.


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