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U.S. Department of Health and Human Services

Safety

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Avandamet (rosiglitazone maleate + metformin hydrochloride) Paxil CR (paroxetine hydrochloride)

Audience: Healthcare providers and consumers

FDA and the Department of Justice have seized the remaining stocks of Paxil CR and Avandamet tablets manufactured by GlaxoSmithKline, Inc. 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 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 there are other products to treat the diseases for which these two products are used.

[March 4, 2005 - FDA News - FDA]