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Tuesday, May 15, 2007

Glaxosmithkline Violations - FDA Step In


Manufacturing Violations Prompt Seizure of Paxil C

In response to ongoing concerns about manufacturing quality, the FDA and the Department of justice recently seized some lots of Paxil CR (paroxetine) and Avandamet (metformin/ rosiglitazone) tablets. Both drugs are manufactured by GlaxoSmithKline Inc. (GSK) of Research Triangle Park, N.C.

Manufacturing practices for the two drugs, approved to treat depression and panic disorder (Paxil CR) and type 2 diabetes (Avandamet), failed to meet the standards laid out by the FDA that ensure product safety, strength, quality, and purity.

"FDA and the Department of Justice will not allow drug manufacturers to ignore our high public health standards for drug manufacturing," says John M. Taylor, FDA associate commissioner for regulatory affairs. "American consumers deserve the best health care products on the market today, and companies that are not adhering to these standards cannot assure FDA and American consumers of the quality of their products."

The FDA is not aware of any harm to consumers by the products subject to this seizure and it does not believe that these products pose a significant health hazard to consumers. The agency urges people who use these two drugs to continue taking their tablets and to talk with their health care provider about possible alternative products for use until the manufacturing problems have been corrected.

Among the violations noted during the FDA's latest inspection of GSK's manufacturing practices was the finding that the Paxil CR tablets could split apart and patients could receive a portion of the tablets that lacks any active ingredient. Additionally, the FDA found that some Avandamet tablets did not have an accurate dose of an active ingredient in this product.

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