Judge OKs sale of generic Paxil despite risk for birth defects
A U.S. judge has ruled that GlaxoSmithKline Plc (GSK) can sell a generic copy of its Paxil CR antidepressant to Apotex Inc., denying a bid from generic drug company Mylan 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 prescribed 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 Zoloft, Celexa, Lexapro, 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 serious 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 developing fetuses, yet the company chose to cover up 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 SSRI makers. Attorneys with Beasley Allen Law Firm are currently investigating cases of birth defects that may have been caused by SSRI use during pregnancy.
- Millions awarded to women in Paxil, birth defects lawsuits
- FDA Advising of Risk of Birth Defects with Paxil
- BMJ confirms FDA’s warning that SSRIs can cause birth defects
- New Study Links Paxil to Twice as Many Birth Defects as Other Antidepressants
- Paxil Maker Sued Over Child Born with Severe Birth Defects