GSK Site Warning Changed Due to FDA Evaluation

Paxil, which is manufactured by GlaxoSmithKline (GSK), is a popular prescription drug given to combat depression. Paxil has been one of the most widely prescribed drugs for its attended use since its introduction into the public market. The brief history of Paxil is not without its blemishes, studies have shown that Paxil has the potential to raise the chance for in some patients.

A 2005 study of Paxil was recently reviewed by the United States Food and Drug Administration (FDA), who now warns the medication could cause a range of birth defects. The review states, that data was collected from over 3,500 women taking Paxil during the first 3 months of pregnancy. Paxil has yet to be banned for use by pregnant women; however the warning was upped from Class C to Class D, meaning there is evidence the drug poses a known risk to unborn children. Although it is not recommended expecting mothers take Paxil, doctors may continue to prescribe it if the benefits for the mother outweigh the risk posed to the fetus.

Since its review of the study the FDA has made the following statement: -FDA is advising health care professionals to discuss the potential risk of birth defects with patients taking Paxil who plan to become pregnant or are in their first three months of pregnancy. Health care professionals should consider discontinuing Paxil (and switching to another antidepressant if indicated) in these patients.-

Also since the review GSK has also placed the following warning on its own website regarding Paxil: “Babies born to mothers who have taken antidepressants, including SSRIs such as Paxil, in the third trimester of pregnancy have reported complications, including difficulties with breathing, turning blue, seizures, changing body temperature, feeding problems, vomiting, low blood sugar, floppiness, stiffness, tremor, shakiness, irritability or constant crying. Tube feeding, help with breathing and longer hospitalization may be needed. There have also been reports of premature births in pregnant women exposed to SSRIs, including Paxil.-

A recent review by the FDA done on a 2005 study of Paxil has shown that the drug can potentially cause in babies born to mothers who took Paxil during pregnancy. If you would like to start using Paxil for your signs and symptoms of depression, consult with your doctor first.


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