SkyePharma suffers on GSK drug seizures

In a response to ongoing concerns about manufacturing quality, the FDA and the Department of Justice seized supplies of the antidepressant Paxil CR and diabetes drug Avandamet. Manufacturing practices for the two drugs failed to meet the standards laid out by the FDA that ensure product safety, strength, quality and purity.

The FDA stated that is not aware of any harm to consumers by the seized products and does not believe the products pose a significant health hazard to consumers. However, 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 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, the 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 US District Courts for the District of Puerto Rico and the Eastern District of Tennessee. The seizures were executed by the US 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 but failed to recall all affected lots of these products, leading to the seizures by federal authorities.