FDA Requests Stronger Ambien Warnings
The FDA is asking the makers of Ambien and similar drugs to strengthen the label warnings on the drugs to disclose these and other risks.
The 13 drugs involved are: Ambien and Ambien CR, made by Sanofi Aventis; Butisol Sodium, made by Medpointe Pharm HLC; Carbrital, made by Parke-Davis; Dalmane made by Valeant Pharm; Doral made by Questcor Pharms; Halcion, made by Pharmacia & Upjohn; Lunesta, made by Sepracor; Placidyl and Prosom, made by Abbott; Restoril, made by Tyco Healthcare; Rozerem, made by Takeda; Seconal, made by Lilly.
There's other side effects too:
Last December, the FDA sent letters to the drug makers, asking them to revise their product labels to include warnings about the potential for severe allergic reactions -- called anaphylaxis -- and severe facial swelling -- called angioedema.
At that time, the FDA also asked the manufacturers to add warnings about complex sleep-related behaviors, including sleep-driving, making phone calls, and preparing and eating food or having sex while asleep, Katz said.
I wonder if Colin Powell would say today as he did in 2003:
"They're a wonderful medication -- not medication. How would you call it? They're called Ambien, which is very good. You don't use Ambien? Everybody here uses Ambien."
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