Glaxo Drugs Seized by FDA

PHARMACEUTICALS

Citing ongoing concerns about manufacturing quality, FDA has seized supplies of two drugs made by GlaxoSmithKline at a plant in Puerto Rico.

The drugs are Paxil CR, a controlled-release version of the depression treatment Paxil (paroxetine), and Avandamet, a type 2 diabetes treatment that combines the active ingredients rosiglitazone and metformin. U.S. marshals acting on behalf of FDA and the Department of Justice seized the supplies at the Cidra, P.R., plant and at distribution facilities in Puerto Rico and Tennessee.

According to FDA, the Paxil tablets in some lots can split apart so that patients may receive a portion of tablet without any active ingredient or a portion with no controlled-release property. Some of the Avandamet tablets, the agency says, may not have an accurate dose of rosiglitazone.

"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 III, FDA's associate commissioner for regulatory affairs. Glaxo says it is working with the agency to resolve the issues as quickly as possible.

Paxil CR is based on technology called Geomatrix from the drug delivery firm SkyePharma. According to SkyePharma literature, the technology is used to create a tablet with two basic components: a core layer containing the active ingredient and one or two barrier layers that control the drug's diffusion out of the core. SkyePharma notes that it provided the formulation of Paxil CR but has no involvement in manufacturing the drug.

FDA says it first uncovered violations of its current Good Manufacturing Practices regulations at the Cidra plant during inspections in 2002. According to the agency, the violations have not been adequately corrected and could result in poor-quality drugs reaching consumers. It says it carried out the seizures because Glaxo failed to recall all affected lots of the products.

The agency adds, however, that neither of the products being seized poses a significant health risk to consumers. It advises patients to continue taking the drugs and to talk to their health care providers about alternatives. Paxil is available in an immediate-release form, and the active ingredients in Avandamet are available individually.

Paxil sales last year were $760 million at current exchange rates, or about 2.3% of Glaxo's total pharmaceutical sales. The firm, which doesn't disclose Avandamet sales, says the financial impact of the seizure on its earnings is currently uncertain.

The seizure is one of several actions taken by FDA in recent years as part of a crackdown on faulty drug manufacturing practices. Schering-Plough, Eli Lilly, Wyeth, and Abbott Laboratories have all been reprimanded by the agency. Schering-Plough, notably, paid a $500 million fine in 2002 related to problems at plants in Puerto Rico and New Jersey.