U.S. marshals seize lots of paroxetine, others
In a response to ongoing concerns about manufacturing quality, the FDA and the Department of Justice initiated seizures of paroxetine (Paxil) CR and rosiglitazone maleate and metformin HCl (Avandamet) tablets manufactured by GlaxoSmithKline (GSK) on March 4.
Manufacturing practices for the two drugs, approved to treat depression and panic disorder, and Type II diabetes, respectively, failed to meet the standards laid out by the FDA that ensure product safety, strength, quality, and purity, the agency reports.
The FDA says it is not aware of any harm to consumers by the products seized, and it does not believe that these products pose a significant health hazard to consumers. Consequently, the 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. The 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 the FDA’s latest inspection was the finding that the paroxetine 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, the FDA found that some rosiglitazone maleate and metformin HCl tablets did not have an accurate dose of rosiglitazone.
The seizures follow warrants issued by the U.S. District Courts for the District of Puerto Rico and the Eastern District of Tennessee. GSK has voluntarily recalled some of the affected lots of paroxetine CR and rosiglitazone maleate and metformin HCl; however, it has failed to recall all affected lots of these products. This failure on the part of GSK resulted in the seizures by federal authorities.
In a response to ongoing concerns about manufacturing quality, the FDA and the Department of Justice initiated seizures of paroxetine (Paxil) CR and rosiglitazone maleate and metformin HCl (Avandamet) tablets manufactured by GlaxoSmithKline (GSK) on March 4.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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