Healthy Skepticism Library item: 840

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Publication type: news

Editoral .
FDA Stops Distribution Of Two Glaxo Drugs
The WALL STREET JOURNAL 2005 Mar 4

Full text:

GlaxoSmithKline said Friday that the Food and Drug Administration has halted distribution of two of its drugs – Paxil and Avandamet – as U.S. marshals seized remaining batches of the drugs because of continued violations at the pharmaceutical giant’s manufacturing plants.

The FDA said, however, that it doesn’t believe the products pose a significant health hazard, and it urged patients who use the drugs to continue taking them.

Glaxo said the FDA action applies to all strengths of depression and panic-disorder drug Paxil CR (12.5 mg, 25 mg, and 37.5 mg), as well as all strengths of Type II-diabetes drug Avandamet (1 mg, 2 mg, and 4 mg).

The FDA said lots of both Paxil and Avandamet were confiscated from the British company’s plants in Puerto Rico and Tennessee.

“Manufacturing practices for the two drugs … failed to meet the standards laid out by FDA that ensure product safety, strength, quality and purity,” the FDA said in a statement. Glaxo had voluntarily recalled some of the affected lots of these products, but hadn’t recalled all of the affected lots. “This failure on the part of GSK resulted in today’s seizures by federal authorities,” the statement said.

Among the violations found in the FDA’s latest inspection, the statement said, were that Paxil CR tablets could split apart, which would mean that 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 FDA also found that Avandamet tablets didn’t have an “accurate dose” of rosiglitazone, which is one of the drug’s active ingredients.

Neither the company nor the FDA believe that consumers were hurt by the drugs, according to statements from both. The FDA added, however, that patients on the drug should speak to their doctors about switching to alternative drugs until the manufacturing problems are corrected.

The FDA said patients taking Paxil CR and Avandamet should continue taking the drugs until they speak to their doctors. “The agency is concerned that GSK’s violation of manufacturing standards may have resulted in the production of poor-quality drug products that could potentially pose risks to consumers,” the FDA said.

Glaxo said that it is working with the FDA to resolve these issues as quickly as possible.