The FDA can give the FDA advice, but the FDA can’t make the FDA listen

File this one in The Annals of FDA Ineptitude.

Here’s what we said about the diet drug Meridia in the January 1998 HSI Members Alert…

“The drug can substantially increase blood pressure and pulse rate in some patients, making it inappropriate for anyone with poorly controlled hypertension, irregular heartbeat, or a history of stroke or heart disease.

“The FDA’s own scientific advisory board found these hazards so disturbing that in 1996 it recommended against approval of Meridia, calling it too risky. In spite of this, the drug has been approved.”

More than 12 years later, FDA officials have organized another advisory panel to determine if cardiovascular risks are too dangerous to keep Meridia (also known as sibutramine) on the market.

In a briefing document for the panel, the FDA offers this food for thought: “Given the modest decrease in body weight associated with sibutramine and the potentially substantial weight regain with discontinuation of therapy, even a small increase in cardiovascular risk seems unwarranted.”

Gee, FDA…wouldn’t it have just been easier (and SAFER!) to listen to that first panel more than a decade ago?

To Your Good Health,

Jenny Thompson

Sources:
“Caution! The FDA’s approval of sibutramine was a dangerous mistake” HSI Members Alert, 1/1/98, hsibaltimore.com
“The FDA Considers Yanking the Meridia Diet Pill” Ed Silverman, Pharmalot, 9/13/10, pharmalot.com

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