SCOUT study results suggests that Meridia may not be worth the risk
Meridia (sibutramine), was first approved in the U.S. in 1997, for use in patients that have no existing issues with heart disease, stroke, blood pressure or eating disorders. You are not supposed to take it if you are over 65, or if you are taking MAO inhibitors or other weight loss medication. It is also contraindicated for patients who have liver or kidney disease and women who are breastfeeding, pregnant or are planning/likely to become pregnant.
The results of a large study, called the SCOUT trial, appeared in this month's New England Journal of Medicine.
Designed to assess the cardiovascular consequences of weight management with and without Meridia in subjects at high risk for cardiovascular events, the SCOUT trial concludes that patients taking the drug had an 11.4% risk of cardiovascular events, while those who took a placebo had a slightly lower 10.0% risk. (NEJM)
In exchange for this 10% increase in the risk of having a stroke or heart attack, "The average patient who responds to the drug loses 4% more body weight below what they might lose with a placebo, an amount considered a modest benefit." (WebMD)
So, if a patient loses 100 pounds, taking Meridia might help them to lose an additional 4 pounds? No thank you!
The results of the SCOUT trial were released last November, which resulted in its removal from the European market.
Yesterday's Los Angeles Times reported that an FDA advisory panel is now making recommendations to remove Meridia from the U.S market as well.
Eight of the sixteen FDA advisory panel members recommend removing Meridai from the U.S. market. Six panelists would rather not see it banned completely, but favor placing more severe limitations on who can prescribe the drug. The other two propose adding a black box warning to help physicians understand who should be taking it.
"None of the panelists on the Endocrinologic and Metabolic Drugs Advisory Committee said the drug should remain on the market in its current form, with labeling that says the drug is not intended for patients with a history of heart disease and other cardiovascular issues. So even if the FDA decides to keep it on the market, doctors will be encouraged to prescribe it in limited circumstances." (LA Times)
Abbott responds to the FDA
Abbott Laboratories issued a Statement on the FDA Advisory Committee Recommendation on Sibutramine this week.
"Sibutramine [Meridia] is approved for weight loss in patients who are either obese or overweight, and have no previous history of cardiovascular disease. The approximately 10,000-patient, six-year SCOUT study was requested by European regulatory authorities as a post-marketing commitment. More than 90 percent of the patients studied in SCOUT had underlying cardiovascular disease or were otherwise ineligible to receive sibutramine under the current labeling and prescribing information."
Are there alternatives to dangerous drugs like Meridia for people who are overweight or obese, and want to lose weight?
Yes. Definitely.
The low-carb lifestyle may be the best available course of action for people who need to lose excess body fat.
You can start today!
Weight loss 101: The low-carb diet is an effective way to burn fat
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