It's hard to tell the difference between the new radio ads for the McDonald's breakfast menu and the "wakefulness" drug Nuvigil because they both begin with the sound of someone snoring and alarm clocks.
But whereas McDonald's helps the morning lethargy with economy priced breakfast items, Nuvigil helps it with a drug that can cause "a serious rash or a serious allergic reaction that may result in hospitalization or be life-threatening," also known as Stevens Johnson syndrome. SJS patients are treated on burn units if they are lucky enough to survive.
You can thank pharma lobbying for the approval of a drug (armodafinil) that causes SJS as an "important treatment option" for conditions that may not even exist like "excessive sleepiness" (ES) and "shift work sleep disorder" (SWSD). You can also thank pharma lobbying for the watered down warning which says, "may result in hospitalization or be life-threatening," instead of "may result in hospitalization or death," the way it was probably originally written.
In fact the FDA rejected Nuvigil's chemical cousin Provigil (modafinil) in 2006 after testimony in advisory committee hearings revealed that up to 400 children were projected to die if it were approved for ADHD. Not get sick; die.
Cephalon's Nuvigil has other perks besides the "rash, hives, sores, swelling, or trouble swallowing or breathing" for which you need to "call your doctor right away or get emergency treatment." It also causes "mania, delusions, hallucinations, suicidal ideation and aggression, some resulting in hospitalization" say company warnings and should be used with caution "in patients with a history of psychosis, depression, or mania."
And for those who think being hospitalized for SJS or a psychiatric meltdown is still preferable to being drowsy at work, there is more bad news. Nuvigil may not even work. It "may not stop your ES [excessive sleepiness] completely," says the prescribing information. Oops.
Still for fans of high-priced brand drugs with copious risks and disputable benefits that insurance companies will pay for, there is also once-monthly Boniva trolled by actress Sally Field.
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