US calls for stronger warnings on sleep drugs

Last Updated: 2007-03-14 13:01:07 -0400 (Reuters Health)

By Susan Heavey

WASHINGTON (Reuters) - The U.S. Food and Drug Administration on Wednesday ordered sleep disorder drugs to carry stronger warnings about their risks, such as drowsy driving and severe allergic reactions.

The warning, which applies to prescription sedative-hypnotic medications, targets 13 drugs such as Sepracor Inc.'s Lunesta and Sanofi-Aventis's Ambien, the agency said.

Dr. Steven Galson, head of FDA's Center for Drug Evaluation and Research, said many of the drugs can be used safely but post-marketing data pointed to some concerns.

"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."

Those risks can include doing various activities such as driving, eating and talking while asleep without any recollection afterward, the FDA said.

Severe allergic reaction known as anaphylaxis, and severe facial swelling, or angioedema, can also occur, even with the first dose.

Sleep drugs made by Abbott Laboratories, Takeda Pharmaceuticals Co. Ltd., Tyco International Ltd.'s Tyco Healthcare unit and others are also affected.

The FDA also recommended that manufacturers of sleep drugs conduct trials to see how often the risks affect patients taking their particular product.

"Although all sedative-hypnotic products have these risks, there may be differences among products in how often they occur," the agency said.

In late morning trading, Sepracor stock was down 94 cents, or nearly 2 percent, to $47.87 and Sanofi shares were down 26 cents, or 0.6 percent, to $41.88.