On February 25, 2008, the European Medicines Agency?s (EMEA) Committee for Medicinal Products for Human Use recommended that new warnings be placed on Novartis? Hepatitis B treatment, Sebivo (sold as Tyzeka in the United States). The warning advises doctors to watch patients treated with the drug for signs of diabetic neuropathy, or a deterioration of the spinal cord and its nerves due to diabetes.

The warning comes after a clinical trial investigating the drug found an increased risk of peripheral neuropathy, or damage to the nervous system.

Tyzeka is co-promoted by Novartis and Idenix, and as approved by the European Commission in April 2007.

Source: ?Warnings coming for Novartis Hepatitis B treatment,? FDAnews Drug Daily Bulletin, February 25, 2008 (http://fdanews.com/newsletter/article?issueId=11339&articleId=104323).