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Many Experts Consulting With FDA Advise Pulling Diet Drug Meridia From Market Due to Heart Risks

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Meridia's days on the U.S. market may be numbered. A panel of independent experts voted on September 15, 2010, to recommend that the Food and Drug Administration ban the obesity medication know generically as sibutramine and sold by Abbott Laboratories. The agency is not bound to follow the recommendation of 8 of the 16 members of the advisory committee, and it may opt instead to add strong warnings about the drug's potential for causing fatal heart  attacks while also placing restrictions on who can prescribe and who can take Meridia.

If FDA follows the lead of European Union and English drug agencies in ordering a halt to Meridia sales and prescriptions, only the drug orlistat would remain as an approved medication for aiding weight loss. Orlistat -- which comes in a full-strength, prescription-only form under the brand name Xenical (Roche) and in a half-strength OTC version labeled Alli (GlaxoSmithKline Consumer Healthcare) -- has its own unwelcome side effects, including loose bowels, flatulence and stomach pain.

But here's the real problem with both Meridia and Xenical/Alli: Neither help people lose all that much weight. Adding either of the medications to a standard regimen of eating less and exercising more produces about an extra 5 lbs. of weight loss over a three-year period. The possibility of losing five extra pounds hardly seems worth the risk of suffering even relatively minor discomfort and embarrassment. Certainly, maybe dropping 5 lbs. isn't worth your life.

While it remains unclear what action FDA will take regarding Meridia, the U.S. agency has a strong track record of recalling weight-loss drugs and dietary supplements when the products prove to be unsafe. From the banning of Fen-Phen in 1997 to the recall of the bodybuilding supplement Hydroxycut in 2009 and this month's rejection of a New Drug application for Arena's lorcaserin, FDA has been quick to withdraw official support from fat-blocking and fat-burning medications shown to harm people's livers, hearts and overall health.

I hope the agency will again act in patients' best interest.

EJL
Richard N. Shapiro
Personal Injury & Wrongful Death Lawyer Serving Va Beach, Norfolk, Chesapeake & all of Virginia
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