Why was Meridia withdrawn from the market?

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Updated December 30, 2014.

Written or reviewed by a board-certified physician. See About.com's Medical Review Board.

Question: Why was Meridia withdrawn from the market?

Meridia (sibutramine) was a prescription medication that worked by enhancing your sense of satiety, thereby reducing your food intake. Meridia was to be used in conjunction with a calorie-controlled diet and regular exercise. It typically lowered patients' weight by an average of 10% over six months to a year. In 2010, it was withdrawn from the U.S.

market.

Answer:

What is Meridia?

Sibutramine was prescribed under the brand name Meridia to be used by overweight patients in combination with a reduced-caloriediet and exercise program to help them lose weight. Sibutramine is an appetite-suppressant that acts on on appetite control centers in the brain to lessen the appetite.

What Were the Known Side Effects of Meridia?

Known side effects of Meridia included increased blood pressure and heart rate, headache and dry mouth. Other side effects included:
  • back pain
  • nervousness
  • difficulty falling asleep or staying asleep
  • runny nose
  • flu-like symptoms
  • painful menstrual periods
Rare side effects included heavy bruising and bleeding, swelling, hives and change in vision.

What Caused Meridia to Go Off the U.S. Market?

The manufacturer, Abbott Laboratories, decided to stop producing sibutramine based on a clinical study that showed people taking sibutramine had an increased risk of cardiovascular events, including heart attack and stroke. Abbott Laboratories voluntarily withdrew Meridia from the U.S.

market because of these risks.
According to the FDA, the study showed a 16% increase in the risk of serious heart events. The FDA concluded that the risk for adverse cardiovascular events outweighed any benefits from the modest weight loss the drug provided.

If You Take Meridia ...

If you are currently taking sibutramine, you should stop taking it and talk your doctor, who can advise you about about alternative weight-loss methods.
If you have experienced a serious side effect (from this or another medication), report it to the Food and Drug Administration's MedWatch Adverse Event Reporting program online at http://www.fda.gov/Safety/MedWatch or by phone at 1-800-332-1088.

Source:

U.S. National Library of Medicine/National Institutes of Health. Sibutramine. U.S. PubMed Health - Sibutramine. 1 Oct 2010.
Source...
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