http://milwaukee.bizjournals.com/boston/stories/2007/03/12/daily31.html

Mass. drug companies targeted by FDA label order

Boston Business Journal - 11:15 AM EDT Wednesday, March 14, 2007

The U.S. Food and Drug Administration on Wednesday ordered all sleep disorder drugs to carry stronger warnings about their risks.

The order, which impacts medication manufactured by Marlborough, Mass.-based Sepracor Inc. (Nasdaq: SEPR), Mansfield, Mass.-headquartered Tyco Healthcare and several other drug-makers, says labeling needs to include stronger language. The risks, according to the FDA, include include severe allergic reactions and complex sleep-related behaviors, which may include sleep-driving

Thirteen medications are the focus of the revised labeling, including Sepracor's Lunesta, Restoril, which is manufactured by Tyco Healthcare and Sanofi-Aventis' Ambien.

"There are a number of prescription sleep aids available that are well-tolerated and effective for many people," said Steven Galson, director of FDA's center for drug evaluation and research. "However, after reviewing the available post-marketing adverse event information for these products, FDA concluded that labeling changes are necessary to inform health care providers and consumers about risks."

Along with the labeling changes, the FDA wants each product manufacturer to send letters to health care providers to notify them about the new warnings. Manufacturers will begin sending these letters to providers starting this week, the FDA said in a statement.