FDA

Chantix Gets A Black Box Warning

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chantixchantixToday the FDA announced that it would be requiring the makers of Chantix, a smoking cessation drug, to put a black box warning on its packaging.  The black box warning is the strongest step the FDA can take, short of pulling a drug from the market.

This New York Times article focuses primarily on the risk of depression and suicide.  The FDA has received 98 reports of suicide and 188 reports of suicide attempts among Chantix users.  However, I vividly recall reading this New York Magazine article first person account of Chantix's other psychological side effects, including terrifying nightmares and psychotic episodes.
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FDA Takes Steps Against Acetaminophen

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TylenolTylenolAcetaminophen - best known as the over the counter medication Tylenol - took a big hit today.  An FDA advisory panel advised that acetaminophen be removed from popular pain control drugs like Vicodin and Percocet, where it appears along with an opiate.  They also advised that the FDA issue a "black box warning," which is the last step the FDA takes before outright banning the sales of a drug.

This story has so many things which surprise me.  First of all, I didn't realize that Vicodin and Percocet include acetaminophen.  Is the hydrocodone not enough?  I looked around, but I couldn't find an answer as to why these prescription pain medications also include some Tylenol.
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Zicam Finally Pulled From Shelves

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Zicam users have been complaining to the FDA and to Zicam's manufacturer since 1999, but their complaints were only validated yesterday, when the Federal Drug Administration issued a consumer alert regarding Zicam use and the possibility of anosmia.

I read about the link between Zicam and anosmia several years ago, and have been avoiding the product ever since.  Years ago I had a friend who suffered from anosmia, and believe me, that is nothing that you want.  When you were a kid, did you ever do that science experiment where you plug your nose and take a bite of a potato and a bite of an apple?  With your nose plugged, you can't tell the difference between them.  That's what life is like, for anosmia sufferers.  Losing your sense of smell has a subtle but profound impact on your quality of life.  Frankly, risking anosmia in order to lessen cold symptoms failed the cost benefit analysis for me.
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The Deadliest Prescription Medications

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Warning Label Needed?Warning Label Needed?Maybe cigarettes aren't the only things that should have warning labels on them. MSN Health and Fitness published an article about the deadliest drugs in the United States. Interesingly enough, this list refers to only legal medications in the United States, or those that the Federal Drug Administration has approved for public use. Read more

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