US Marshals Seize Supplies of GSK Paxil CR, Avandamet

March 10, 2005
Pharmaceutical Technology Editors
Pharmaceutical Technology

US Marshals Seize Supplies of GSK Paxil CR, Avandamet


On March 4, US marshals seized stocks of "Avandamet" (rosiglitazonemaleate/metformin hydrochloride, for type 2 diabetes) and "Paxil CR"(paroxetine hydrochloride controlled release, for depression andanxiety) from GlaxoSmithKline (GSK, Brentford, UK, www.gsk.com) locations inKnoxville, TN, Cidra, PR, and another unspecified location in PuertoRico.

The marshals acted on warrants obtained by the US Food and DrugAdministration. Both drugs are formulated as tablets; FDA complainedthat longstanding and uncorrected manufacturing problems producedflawed tablets with unreliable amounts of active pharmaceuticalingredients.

In its officialstatement on the seizures, FDA said that the Paxil CR tablets"could split apart and patients could receive a portion of the tabletsthat lacks any active ingredient, or alternatively a portion thatcontains active ingredient and does not have the intendedcontrolled-release effect." The agency also found that "some Avandamettablets did not have an accurate dose of rosiglitazone."

FDA's statement advised patients and doctors that, "FDA is not awareof any harm to consumers by the products subject to this seizure and itdoes not believe that these products pose a significant health hazardto consumers. Consequently, FDA urges patients who use these two drugsto continue taking their tablets and to talk with their health careprovider about possible alternative products for use until themanufacturing problems have been corrected."

GSK'sstatement on the seizures (which it referred to as a "disruption ofsupply") said the action applied to all strengths of Paxil CR andAvandamet, and noted that, "The company is working with the FDA toresolve 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 componentsin the other. The company declined to comment on possible causes of themanufacturing problems while the matter is still under investigation.

A review of FDA Warning Letters published since 2000 failed to turnup any previous CGMP citations for either product. At deadline, FDA hadnot responded to requests for earlier warning documents, nor torequests for information on observations made on inspection reports.

–Doug McCormick