In a response to ongoing concerns about manufacturing quality, the Food and Drug Administration (FDA) and the Department of Justice today initiated seizures of Paxil CR and Avandamet tablets manufactured by GlaxoSmithKline, Inc. (GSK). Manufacturing practices for the two drugs, approved to treat depression and panic disorder (Paxil CR) and Type II Diabetes (Avandamet), failed to meet the standards laid out by 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," said 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 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. FDA has determined that neither product is medically necessary and that alternative products are available for consumer use.
The agency is concerned that GSK'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 FDA's latest inspection 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, or alternatively a portion that contains active ingredient and does not have the intended controlled-release effect. Additionally, FDA found that some Avandamet tablets did not have an accurate dose of rosiglitazone, an active ingredient in this product.
The seizures follow warrants issued by the U.S. District Courts for the
District of Puerto Rico and the Eastern District of Tennessee. The seizures were
executed today by the U.S. Marshals Service at GSK's Cidra, Puerto Rico
manufacturing facility, its Knoxville, Tennessee distribution facility, and a
Puerto Rico distribution facility. GSK has voluntarily recalled some of the
affected lots of Paxil CR and Avandamet; however, it has failed to recall all
affected lots of these products. This failure on the part of GSK resulted in
today's seizures by federal authorities.
Source: FDA news release #P05-10, March 4, 2005
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