FDA Seizes Depression, Diabetes Drugs
Citing poor manufacturing practices at three GlaxoSmithKline production plants, the U.S. Food and Drug Administration has seized inventories of two prescription drugs to treat depression and type 2 diabetes, the FDA announced Friday.
The seizure by U.S. marshals at plants in Puerto Rico and Tennessee involved the antidepressant Paxil CR (controlled release) and the diabetes medication Avandamet. In a statement on its Web site, the agency said several inspections since 2002 had uncovered poor manufacturing practices that hadn't been corrected.
The firm had recalled some of the affected lots, but its failure to recall all affected products forced the FDA to seek court permission for the drugs' seizure, the agency said.
The FDA said it wasn't aware of any reports of harm to consumers, and recommended that people who currently have supplies of these drugs continue to take them. In the long-term, the agency suggested, patients should speak to their doctor about finding alternatives until the manufacturing deficiencies are fixed.
The FDA said recent inspections found that "Paxil CR tablets could split apart and patients could receive a portion of the tablets that lacks any active ingredient or alternatively a portion that contains active ingredient and does not have the intended controlled-release effect." The immediate release form of Paxil is not affected, the agency said.
Some of the Avandamet tablets, the FDA noted, were found to contain inaccurate amounts of the active ingredient, rosiglitazone.
The FDA acknowledged the possibility of shortages of both medications until the manufacturing problems are corrected.
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