FDA Seizes Paxil CR

FDA Seizes Two GlaxoSmithKline Medications

Posted on March 05, 2005


The Food and Drug Administration (FDA) announced on Friday that it has seized tablets from drug maker GlaxoSmithKline used to treat depression and type II diabetes.

The Food and Drug Administration (FDA) announced on Friday that it has seized tablets from drug maker GlaxoSmithKline used to treat depression and type II diabetes.

Using US Marshals, the FDA went into GlaxoSmithKline plants in Puerto Rico and Tennessee which are involved in the production of the antidepressant drug Paxil CR and the diabetes drug Avandamet.

The FDA says that GlaxoSmithKline failed to meet the standards to ensure product safety, strength, quality and purity.

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

Specifically, the FDA found during their latest inspection that the Paxil CR pills could split apart eaning consumers could receive a part of a tablets that lacks any active ingredient, or alternatively a portion that has the active ingredient but does not have the intended controlled-release effect. And they also discovered that some Avandamet tablets did not have an accurate dose of the active ingredient rosiglitazone.

The FDA said it wasn't aware of any immediate harm to consumers who take the drugs. But they did recommend that consumers check with their health care provider about alternate tablets until the manufacturing issues have been corrected.
-- Newsbug.net