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Morning Blues? Try Nuvigil Not McDonald's!

By       Message Martha Rosenberg     Permalink
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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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Boniva is a bisphosphonate bone drug, which pharma thought would replace its other wonder drugs for women, hormone therapy until, like HT, they were found to cause the very conditions they were supposed to ameliorate.

As early as 2004, Gordon Strewler, MD in the New England Journal of Medicine and Susan M. Ott, MD in the Annals of Internal Medicine warned bisphosphonate-treated bones could become brittle and fracture-prone and bisphosphonates may actually cause what they were supposed to prevent.

The next year, an article in the Journal of Clinical Endocrinology & Metabolism warned that Fosamax, another bisphosphonate, caused "increased susceptibility to, and delayed healing of, nonspinal fractures." And articles citing "atypical skeletal fragility," "subtrochanteric stress fractures" and "low-energy femoral shaft fractures" caused by bisphosphonates have appeared in the Journal of Clinical Endocrinology & Metabolism, Journal of Orthopedic Trauma and the journal Injury.

And there are other perks to bisphosphonates like Boniva besides broken bones.

According to this week's British Medical Journal, "The risk for esophageal cancer nearly doubled in patients given 10 or more prescriptions for oral bisphosphonates, and the risk associated with the drugs increased over time." The FDA found similar "safety signals."

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No wonder the Boniva radio ads say not to take Boniva if you have difficult or painful swallowing, chest pain or continuing or severe heart burn or you can't sit or stand for an hour.

You also don't want to take Boniva if you have low blood calcium or severe kidney disease or if severe bone, joint and/or muscle pain develops as other journal articles say is likely. In fact the risks with Boniva are so severe when Field says "You have only one body and one life" at the end of the commercial, you expect her to say, "so don't take Boniva."

 

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Martha Rosenberg is an award-winning investigative public health reporter who covers the food, drug and gun industries. Her first book, Born With A Junk Food Deficiency: How Flaks, Quacks and Hacks Pimp The Public Health, is distributed by Random (more...)
 

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