The FDA expressed concern that GSK's violation of manufacturing standards might have resulted in the production of poor quality drug products that could pose risks to consumers.

Manufacturing practices for the two drugs -- approved to treat depression and panic disorder (Paxil CR), and Type II Diabetes (Avandamet) -- have failed to meet FDA standards for product safety, strength, quality and purity, the agency says.

"FDA and the Department of Justice will not allow drug manufacturers to ignore our high public health standards for drug manufacturing," says John M. Taylor, FDA Associate Commissioner for Regulatory Affairs, in a statement.

"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," he added.

No Significant Health Hazard

The FDA acknowledged that it was not aware of any harm to consumers by the products seized and that it did not believe the products posed a significant health hazard to consumers.

The agency is urging patients who use Paxil and Avandamet to continue taking their medication and to talk with their healthcare providers about possible alternative products for use until the manufacturing problems have been corrected.

The FDA noted that neither product is medically necessary, and that alternative products are available for consumer use.

Potential Risks to Consumers

The FDA expressed concern that GSK's violation of manufacturing standards might have resulted in the production of poor quality drug products that could pose risks to consumers.

Among the violations noted during the agency's latest inspection was the finding that the Paxil CR tablets could split apart, and patients could receive a portion that lacks any active ingredient. Alternatively, patients could receive a portion that contains active ingredient but 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.

Voluntary Recall Incomplete

The FDA 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, according to the FDA.