Judge OKs sale of generic Paxil despite risk for birth defects

Posted: March 16, 2012 Author: Jennifer Walker-Journey Pharmaceutical

paxil 150x144 Judge OKs sale of generic Paxil despite risk for birth defectsA U.S. judge has ruled that GlaxoSmithKline Plc (GSK) can sell a generic copy of its CR antidepressant to Apotex Inc., denying a bid from generic drug company to block the sale. Mylan signed a two-year agreement in 2008 to market a copy of Paxil. It claimed GSK was breaching its contract by selling a copy of Paxil to another drug company.

Since Paxil was approved by the Food and Drug Administration (FDA) in 1992, it has become one of the most widely antidepressants in the world. Paxil is in a class of medications known as selective serotonin reuptake inhibitors, or SSRIs. Other antidepressants in this class include , Celexa, , and Prozac.

In January 2012, the British Medical Journal published a study that showed SSRIs, if taken during pregnancy, may increase a woman’s chance of delivering a baby with persistent pulmonary hypertension. In 2010, GSK was ordered to pay $2.5 million to the family of a 3-year-old boy who was born with heart defects that required multiple surgeries during the first six months of his life. The boy’s mother alleged that the drug company knew that Paxil could cause problems for , yet the company chose to this information so as not to hurt the growing profits from drug sales.

GSK faces more birth defects lawsuits, and similar cases have been filed against other makers. Attorneys with Law Firm are currently investigating cases of birth defects that may have been caused by SSRI use during pregnancy.

Source: Bloomberg

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