US Marshals Seize Supplies of GSK Paxil CR, Avandamet - Pharmaceutical Technology

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US Marshals Seize Supplies of GSK Paxil CR, Avandamet

Pharmaceutical Technology

US Marshals Seize Supplies of GSK Paxil CR, Avandamet
On March 4, US marshals seized stocks of "Avandamet" (rosiglitazone maleate/metformin hydrochloride, for type 2 diabetes) and "Paxil CR" (paroxetine hydrochloride controlled release, for depression and anxiety) from GlaxoSmithKline (GSK, Brentford, UK, www.gsk.com) locations in Knoxville, TN, Cidra, PR, and another unspecified location in Puerto Rico.

The marshals acted on warrants obtained by the US Food and Drug Administration. Both drugs are formulated as tablets; FDA complained that longstanding and uncorrected manufacturing problems produced flawed tablets with unreliable amounts of active pharmaceutical ingredients.

In its official statement on the seizures, FDA said that the 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 agency also found that "some Avandamet tablets did not have an accurate dose of rosiglitazone."

FDA's statement advised patients and doctors that, "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. Consequently, FDA urges patients 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."

GSK's statement on the seizures (which it referred to as a "disruption of supply") said the action applied to all strengths of Paxil CR and Avandamet, and noted that, "The company is working with the FDA to resolve these issues as quickly as possible."

A company spokesman noted that Paxil CR is a two-layer formulation, with active ingredient in one layer and controlled-release components in the other. The company declined to comment on possible causes of the manufacturing problems while the matter is still under investigation.

A review of FDA Warning Letters published since 2000 failed to turn up any previous CGMP citations for either product. At deadline, FDA had not responded to requests for earlier warning documents, nor to requests for information on observations made on inspection reports.

–Doug McCormick


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