GlaxoSmithKline Medicines Halted

    March 4, 2005

The FDA has halted distribution of supplies of two of GlaxoSmithKline’s medicines due to manufacturing issues.

Avandamet (rosiglitazone maleate/metformin hydrochloride) tablets, used to treat type 2 diabetes, and Paxil CR (paroxetine hydrochloride controlled release) tablets, a treatment for depression and several anxiety disorders.

The FDA action relates to all strengths of Paxil CR (12.5 mg, 25 mg, and 37.5 mg) as well as Avandamet (1 mg, 2 mg, and 4 mg). In the short term, it is expected that the FDA action will result in a shortage of patient supplies for both of these medicines.

GSK believes that the manufacturing issues do not pose a health risk to patients. GSK agrees with the FDA that patients who use these two medicines should continue taking their tablets and talk with their healthcare provider if they have questions.

The company is working with the FDA to resolve these issues as quickly as possible.

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