Sleep Driving and new warning labels
Earlier in the week we talked about the issue of driving under the influence of other drugs besides alcohol. One of the cautionary points included sleeping medication – sedative drugs such as Ambien, Restoril and Lunesta.
Just a couple of days ago, the U.S. Food and Drug Administration (FDA) requested that all manufacturers of these types of drugs strengthen their product labeling to include stronger language concerning potential risks. These risks include severe allergic reactions and complex sleep-related behaviors, which may include 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.
Steven Galson, M.D., MPH, director of FDA’s Center for Drug Evaluation and Research was quoted in an FDA release as saying, "…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."
Other recorded incidents from taking these drugs included making phone calls and even cooking and eating – all with no recollection afterward due to the hypnotic state.
The medications that are the focus of the revised FDA labeling include the following 13 products:
Ambien/Ambien CR (Sanofi Aventis)
Butisol Sodium (Medpointe Pharm HLC)
Carbrital (Parke-Davis)
Dalmane (Valeant Pharm)
Doral (Questcor Pharms)
Halcion (Pharmacia & Upjohn)
Lunesta (Sepracor)
Placidyl (Abbott)
Prosom (Abbott)
Restoril (Tyco Healthcare)
Rozerem (Takeda)
Seconal (Lilly)
Sonata (King Pharmaceuticals)
Aside from individuals asking for and receiving prescriptions from their doctors for these drugs, especially when seeing the clever marketing campaigns on television, more than a quarter million people used the drug non-medically in 2004. Nearly 60 percent of people who used these drugs without prescriptions said they got them from a friend or relative for free.
Despite some of these drugs seeming relatively benign in concept and promotion, this is yet another example of dangerous side effects being found after being released on the market.
Do you have any examples of things like this happening to people you know?
Article by Eric
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Just a couple of days ago, the U.S. Food and Drug Administration (FDA) requested that all manufacturers of these types of drugs strengthen their product labeling to include stronger language concerning potential risks. These risks include severe allergic reactions and complex sleep-related behaviors, which may include 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.
Steven Galson, M.D., MPH, director of FDA’s Center for Drug Evaluation and Research was quoted in an FDA release as saying, "…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."
Other recorded incidents from taking these drugs included making phone calls and even cooking and eating – all with no recollection afterward due to the hypnotic state.
The medications that are the focus of the revised FDA labeling include the following 13 products:
Ambien/Ambien CR (Sanofi Aventis)
Butisol Sodium (Medpointe Pharm HLC)
Carbrital (Parke-Davis)
Dalmane (Valeant Pharm)
Doral (Questcor Pharms)
Halcion (Pharmacia & Upjohn)
Lunesta (Sepracor)
Placidyl (Abbott)
Prosom (Abbott)
Restoril (Tyco Healthcare)
Rozerem (Takeda)
Seconal (Lilly)
Sonata (King Pharmaceuticals)
Aside from individuals asking for and receiving prescriptions from their doctors for these drugs, especially when seeing the clever marketing campaigns on television, more than a quarter million people used the drug non-medically in 2004. Nearly 60 percent of people who used these drugs without prescriptions said they got them from a friend or relative for free.
Despite some of these drugs seeming relatively benign in concept and promotion, this is yet another example of dangerous side effects being found after being released on the market.
Do you have any examples of things like this happening to people you know?
Article by Eric
Digg It | Reddit | Newsvine Seed
Add to your bookmarks in:
del.icio.us | Yahoo! | Google | Furl | ma.gnolia | Spurl
Labels: driving, prescription
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