Batches of the drugs Paxil and Avandamet seized by federal officials

Mar 5 2005

Batches of the drugs Paxil CR and Avandamet United States, were seized by marshals at manufacturing and distribution plants in Tennessee and Puerto Rico after federal officials said the manufacturer failed to correct violations of production safety standards.

The drugs were seized at GlaxoSmithKline plants, one in Knoxville and two in Puerto Rico, on orders from the Department of Justice and the United States Food and Drug Administration. Paxil CR is a controlled-release antidepressant and Avandamet a diabetes drug .The F.D.A. had told the manufacturer in letters and warnings issued over the last three years, that problems their inspectors found with the drugs' production had to be corrected.

Although GlaxoSmithKline voluntarily recalled some of the affected lots, it failed to recall all affected products, forcing the agency to seek warrants from the United States District Courts for the seizure of the drugs.Drug manufacturers will not be allowed to ignore our high public health standards for drug manufacturing,said John M. Taylor, the F.D.A.'s associate commissioner for regulatory affairs.

Officials said they knew of no harm to any consumers as a result of the violations, and does not believe these products pose a significant health hazard to consumers.There was concern that GSK's violation of manufacturing standards could have resulted in the production of poor quality drug products with a potential risk to consumers.

Consumers should continue taking their medication but should talk to their doctors about the possibility of using alternative products until manufacturing problems are resolved.The company appears to have been penalised for not acting quickly enough to remove the products from the market, and it forced the agency's hand.

Officials for the drug manufacturer said they were working as quickly as possible. with the F.D.A. to correct the problems.

It was found that some Avandamet tablets did not have an accurate dose of rosiglitazone, an active ingredient in the product, and 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."

All remaining stocks of the two drugs were seized, to prevent further distribution of the products.

The F.D.A. has recently been under fire for not acting quickly enough in its oversight of the withdrawn pain pill Vioxx. Last week, a senate committee began hearings on whether the agency adequately monitors the safety of all drugs.