If you currently take Ambien,Butisol Sodium, Carbrital, Dalmane, Doral, Halcion, Lunesta, Placidyl, Prosom, Restoril, Rozerem, Seconal, and/or Sonata you ought to be aware of a recent concern issued by the U.S. Food and Drug Administration relating to their use in connection with some very serious side effects. The drugs listed above are commonly prescribed to millions of consumers to address sleeping disorders and often promise a restful nights sleep. According to the FDA, these drugs are causing people to do more than get a good nights sleep-it is also causing them to suffer severe allergic reactions as well as undertake unique sleep-related behaviors such as “sleep driving.”
Sleep driving is defined as driving while not fully awake after ingestion of a sedative-hypnotic product, with no memory of the event.
These behaviors and side effects prompted the FDA in December of 2006 to request all the above drugs to include stronger warnings about these issues so as to help limit this unwanted effects. According to the letters sent to the manufactures by the FDA, the following information should be contained in their revised warnings so as to alert the public to these potentially deadly side effects and risks:
â€¢ Anaphylaxis (severe allergic reaction) and angio edema (severe facial swelling), which can occur as early as the first time the product is taken.
â€¢ Complex sleep-related behaviors which may include sleep-driving, making phone calls, and preparing and eating food (while asleep).
FDA has been working with the product manufacturers over the past three months to update labeling, notify health care providers and inform consumers of these risks.
Along with the labeling revisions, FDA has requested that each product manufacturer send letters to health care providers to notify them about the new warnings. Manufacturers will begin sending these letters to providers starting this week.
This information is very important news for the millions of Americans who use these products on a daily basis. There have already been numerous reports of people reportedly sleep driving and subsequently causing serious auto accidents without the faintest memory of the event after it occurs. Anything that promotes more public awareness to such potential deadly effects is a great idea given the alternative here. The more one knows in taking these medications, the better apt they are to prevent such problems from occurring in the future and that will make everyone a little more safer as a result.
A partner with Childers, Schlueter & Smith, LLC,, Brandon Smith has devoted his practice to pharmaceutical litigation, mass torts, products liability and serious personal injury. A frequent guest speaker at legal seminars all over the country—Brandon is focused on helping injured victims nationwide, however possible. Named a SuperLawyer again in 2019, he has also been called out as one of 10 Best Attorneys For Georgia by the American Institute Of Personal Injury Attorneys and a Top 100 Lawyer in Georgia by the National Trial Lawyers in 2019.
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