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Paxil CR Back on Pharmacy Shelves

June 27, 2005
GlaxoSmithKline says its anti-depressant Paxil CR, seized by federal health authorities in March because of manufacturing problems that may have made the drug unsafe, is now on sale once again. The company said U.S. pharmacies had received new shipments, and that overseas distribution would resume shortly.

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Inspectors for the Food and Drug Administration moved in in March to remove supplies of Paxil and another drug from the firm’s distribution center in Tennessee and two warehouses in Puerto Rico because they did not meet manufacturing standards.

FDA voiced concern that the Paxil tablets could split apart, meaning patients might not get a full dose. There were also allegations that a batch of the other drug -- the diabetes pill Avandamet -- was missing an active ingredient.

GlaxoSmithKline voluntarily recalled batches of the drugs in February, but FDA inspectors wanted the company to recall all of the drugs. They carried out the seizures the following month, they said, to make sure none of the tainted drugs made it to the public.

Meanwhile, Glaxo says it has fixed the manufacturing problems and had changes in its operations certified, as required, by a third party. It says supplies of Avandamet should reach American pharmacies during July.

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