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FDA Seizes Paxil, Avandamet Tablets

March 9, 2005 — U.S. marshals have seized tablets of the antidepressant Paxil CR and the diabetes drug Avandamet from several facilities because of manufacturing problems, the FDA says.

However, the FDA says in a news release that it does not believe there is any significant danger to patients taking either drug. The FDA urges patients to keep taking the drugs and to discuss alternatives with their doctors until the problem is cleared up.

Paxil is used to treat depression and panic disorder. Avandamet is prescribed for diabetes. Only the long-acting version of Paxil – called Paxil CR — is affected by this seizure. The immediate- release form – called simply Paxil — is not affected.

Manufacturing practices for the two drugs failed to meet FDA standards for product safety, strength, quality, and purity, says the FDA. The manufacturer, GlaxoSmithKline, has voluntarily recalled some of the affected products but not all of them, prompting today’s seizures, says the FDA.

The seizures took place at GlaxoSmithKline’s plant in Cidra, Puerto Rico, and at distribution facilities in Puerto Rico and Knoxville, Tenn.

“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.

“Once we discover a company is not following the standards, which were created to ensure safety and quality, we expect them to correct the deficiencies in an expedited manner. 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.”

“FDA has determined that neither product is medically necessary and that alternative products are available for consumer use,” says the FDA statement.

The FDA says it’s concerned that GlaxoSmithKline’s violation of manufacturing standards may have resulted in the production of poor-quality drug products that could potentially pose risks to consumers.

Among the violations noted during the FDA’s latest inspection was the finding that the Paxil CR tablets could split apart. That could leave patients with a portion of the tablets lacking any active ingredient. Or patients might receive part of a tablet that contains active ingredient but lacks the intended controlled-release effect.

The FDA also says some Avandamet tablets did not have an accurate dose of rosiglitazone, an active ingredient in the drug. Avandamet is a combination of two diabetes medications, rosiglitazone and metformin.

Posted by: Dr.Health

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