Meridia removed from market

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Meridia (sibutramine): Market Withdrawal Due to Risk of Serious Cardiovascular Events

October 8, 2010

Audience: Primary Care, Consumers

ISSUE: Abbott Laboratories and FDA notified healthcare professionals and patients about the voluntary withdrawal of Meridia (sibutramine), an obesity drug, from the

U.S. market because of clinical trial data indicating an increased risk of heart attack and stroke.

BACKGROUND: Meridia was approved November 1997 for weight loss and maintenance of weight loss in obese people, as well as in certain overweight people with other risks

for heart disease. The approval was based on clinical data showing that more people receiving sibutramine lost at least 5 percent of their body weight than people on placebo who relied on diet and exercise alone. FDA has now requested market withdrawal after

reviewing data from the Sibutramine Cardiovascular Outcomes Trial (SCOUT). SCOUT is part of a postmarket requirement to look at cardiovascular safety of sibutramine after the European approval of the drug. The trial demonstrated a 16 percent increase in the

risk of serious heart events, including non-fatal heart attack, non-fatal stroke, the need to be resuscitated once the heart stopped, and death, in a group of patients given sibutramine compared with another given placebo. There was a small difference in weight

loss between the placebo group and the group that received sibutramine.

RECOMMENDATION: Physicians are advised to stop prescribing Meridia to their patients, and patients should stop taking this medication. Patients should talk to their

health care provider about alternative weight loss and weight loss maintenance programs.

Read more: http://www.drugs.com/fda/meridia-sibutramine-market-due-risk-serious-cardiovascular-events-12831.html#ixzz11yDeS27p

Tina Musselman RD, CCN

St. Hospital, Olympia Fields, IL

Bariatric Surgery Program Coordinator

Registered Dietitian/Certified Clinical Nutritionist

(708) 679-2717 (p)

(708) 679-2418 (f)

tina.musselman@...

www.stjameshospital.org/services/bariatricsurgery

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