FDA Drug Safety Communication: FDA Recommends Against the Continued Use of Meridia (sibutramine)

By Effective Medicine  On  In Drugs Tagged ,  


 

Safety Announcement
Additional Information for Patients
Additional Information for Healthcare Professionals
Data Summary

Safety Announcement 

[10-8-2010] The U.S. Food and Drug Administration (FDA) is recommending against continued prescribing and use of Meridia (sibutramine) because this drug may pose unnecessary cardiovascular risks to patients. FDA has requested that Abbott Laboratories—the manufacturer of Meridia—voluntarily withdraw this drug product from the United States market. Abbott has agreed to voluntarily stop marketing of Meridia in the United States.

Meridia was FDA-approved in November 1997 for weight loss and maintenance of weight loss in patients with a body mass index (BMI) greater than or equal to 30 (≥30) kg/m2 or for patients with a BMI ≥27 kg/m2 who have other cardiovascular risk factors. BMI is a measure of body fat in adults that is based on height and weight. Patients with a BMI ≥30 kg/m2 are considered obese.

FDA’s recommendation is based on new data from the Sibutramine Cardiovascular Outcomes (SCOUT) trial, which demonstrated a 16% increase in risk of major adverse cardiovascular events (a composite of non-fatal heart attack, non-fatal stroke, resuscitation after cardiac arrest and cardiovascular death) in patients treated with Meridia compared to patients taking a placebo (see Data Summary below). At the end of the trial (60 months), patients in the Meridia group lost a small amount of body weight compared to patients in the placebo group. FDA has concluded that the risk for an adverse cardiovascular event from Meridia in the population studied outweighed any benefit from the modest weight loss observed with the drug.

In November 2009, and January 2010, FDA announced it was reviewing clinical trial data about a potentially serious effect on the heart from the use of Meridia. The links to these communications are listed below: 

  • Early Communication about an Ongoing Safety Review of Meridia (sibutramine hydrochloride)
  • Follow-Up to the November 2009 Early Communication about an Ongoing Safety Review of Sibutramine, Marketed as Meridia

Federal Drug Disposal Guidelines:

  • Take your Meridia out of its original container and mix it with an undesirable substance, such as used coffee grounds or kitty litter. The medication will be less appealing to children and pets, and unrecognizable to people who may intentionally go through your trash.
  • Put the medication in a sealable bag, empty can, or other container to prevent it from breaking out of a garbage bag.
  • Report any side effects with Meridia to FDA’s MedWatch program using the information at the bottom of the page in the “Contact Us” box.

    • September 15, 2010 AC meeting).

     

        




    Contact Us

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      Regular Mail: Use postage-paid FDA Form 3500

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