Paxil Manufacturer Recalls Drug After FDA Knuckle Rapping

Caroline Cassels

Disclosures

April 04, 2014

Following a letter from the US Food and Drug Administration (FDA) citing potential contamination of paroxetine, the active ingredient in the antidepressants Paxil/Seroxat, during the manufacturing process, the drugs' maker, GlaxoSmithKline (GSK), recalled certain batches of the antidepressant to wholesalers.

The FDA's letter to GSK following its inspection of the company's manufacturing plant in Cork, Ireland, in October 2013 states that paroxetine was contaminated with material from the plant's pharmaceutical waste tank.

The FDA letter states that until GSK corrects these manufacturing deviations, it "may withhold approval of any new applications or supplements listing your firm as an API [active pharmaceutical ingredient] manufacturer."

According to the company, it is taking the FDA's statement "very seriously."

"GSK acknowledges the concerns raised by the FDA and we are recommending a Class 3 recall ― that is a recall from wholesalers ― of certain batches of Paxil/Seroxat containing the paroxetine API supplied by the Cork site that are implicated in the Warning Letter. Based on a medical assessment, GSK considers that there is no increased risk of harm to patients taking finished product manufactured from the implicated batches of paroxetine API," the company said in a statement.

The company added that it is currently "reviewing the content of the Warning Letter to assess the concerns raised, in order to develop appropriate Corrective and Preventative Actions. We will be able to comment further once we have prepared and submitted a comprehensive response to the Warning Letter to FDA by April 9."

This recall marks the second time in as many weeks that the company has recalled a product. Last week, as reported by Medscape Medical News, the company's weight-loss drug orlistat (alli) was recalled because of potential tampering concerns.

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