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The United States Food and Drug Administration (FDA) has requested that the makers of all sedative-hypnotic drugs such as Ambien and Seconal expand the label warnings to include newly discovered potential risks, including strange behavior during sleep and severe allergic reactions.
The FDA has found that some people who take these drugs, which are used to induce and maintain sleep, have caused some people to perform complex activities while they are asleep, such as drive, and prepare and eat food.
Newly Discovered Side Effects
“There are a number of prescription sleep aids available that are well-tolerated and effective for many people,” said director of the FDA's Center for Drug Evaluation and Research, Steven Galson, MD, MPH. “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.”
The FDA sent letters to sleep aid drug manufacturers requesting that they change the warning labeling to include the following possible dangerous side effects:
- Complex, unusual patterns of behavior during sleep, which may include driving, making phone calls, and preparing and eating food all while sleeping
- Anaphylaxis, which is a severe allergic reaction marked by a swelling face
Other FDA Requests
The FDA has also requested that along with the label revisions, the drug manufacturers send letters out to physicians and health care providers to notify them of the warnings. The letters are scheduled to be sent out this week.
In addition, the FDA requested that these manufacturers develop medication guides for patients to inform them of the risks of taking the drugs. These are to be given out to patients and their families when the drugs are first dispensed.
The Drugs
The labels of the following drugs are to be changed: Ambien, Ambien CR, Butisol Sodium, Carbrital, Dalmane, Doral, Halcion, Lunesta, Placidyl, Prosom, Restoril, Rozerem, Seconal, and Sonata.
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