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Avandamet is a combination product containing 2 drugs (rosiglitazone maleate and metformin hydrochloride) for the treatment of type 2 diabetes mellitus.
Paxil CR is a controlled release medication for the treatment of major depressive disorder and panic disorder.
FDA and the Department of Justice have filed three actions in federal court to seize remaining stocks of these products (Avandamet and Paxil CR) in three locations. The seizures are meant to prevent further distribution of the products.
FDA took this action because several inspections of the GSK manufacturing facility where these products are made since 2002 revealed significant violations of FDA's current Good Manufacturing Practice (GMP) regulations at this facility. These violations have not been adequately corrected by the firm and could result in production of poor quality drug products that potentially could pose risks to consumers.
FDA inspections of the facility that manufactures Avandamet and Paxil CR revealed deficiencies in the process controls in place to help assure manufacturing conditions and practices result in a high quality product.
FDA inspections revealed that some lots of Avandamet tablets are not always manufactured uniformly and that these tablets may not have an accurate dose of rosiglitazone (one of the two active ingredients in Avandamet). FDA also found that some lots of Paxil CR tablets are not manufactured properly and can split apart, so that patients may receive a portion of the tablets that lack any active ingredient or a portion that contains the active ingredient and does not have the intended controlled-release effect.
The seizure of Avandamet and Paxil CR could result in a lack of availability of both drugs until the company is able to correct the manufacturing problems that necessitated the seizure.
FDA has determined that there are other products to treat the diseases for which these two products are used.
Approved versions of the individual components of Avandamet (i.e., rosiglitazone and metformin) are available in the same doses as those found in the combination Avandamet tablets subject to seizure, with the exception of the 1 mg dose of rosiglitazone.
Approved versions of the immediate release form of Paxil are also available.
FDA will attempt to ensure that the manufacturer corrects the manufacturing deficiencies as soon as possible so that production of new product that meets our public health high quality standards can occur.
Patients taking either of these drugs should continue taking their Avandamet and/or Paxil CR tablets and should talk to their health care provider about alternative forms of rosiglitazone (Avandia), metformin and/or Paxil or alternative products that could be taken until the manufacturing problems with these drugs have been corrected.
FDA does not believe that the products subject to this seizure pose a significant health hazard to consumers.
FDA is concerned that the extent of the manufacturing problems noted at the Cidra GSK facility could adversely affect the quality of these drug products, resulting in potential risk to consumers.
The following doses of Avandamet and Paxil CR tablets are subject to the seizure:
No, 10 mg, 20 mg, 30 mg, 40 mg of the immediate release form of Paxil are approved and not subject to these seizures. Patients can take these with confidence.
More Information: "U.S. Marshals Seize Lots of GlaxoSmithKline's Paxil CR and Avandamet Tablets Because of Continuing Good Manufacturing Practice Violations" (Press Release, March 4, 2005)