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FDA Drug Safety Podcast for Healthcare Professionals: FDA Recommends Against the Continued Use of Meridia (sibutramine)

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Welcome, my name is Jennifer Shepherd, a pharmacist in the Division of Drug Information.  On October 8, 2010, the Food and Drug Administration (FDA) issued a Drug Safety Communication recommending against continued prescribing and use of Meridia, or 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, or BMI, greater than or equal to (≥30) 30 or for patients with a BMI ≥27 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 are considered obese.

FDA’s recommendation is based on new data from the Sibutramine Cardiovascular Outcomes, or 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.  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 can be found at www.fda.gov/Drugs/DrugSafety.

The SCOUT trial was a randomized, double-blind, placebo-controlled multicenter trial conducted between January 2003 and March 2009 in Europe, Latin America, and Australia. The study population consisted of approximately 10,000 men and women aged ≥55 with a BMI between 27 and 45, or between 25 and 27 with an increased waist circumference. Patients were also required to have a history of cardiovascular disease (coronary artery disease, stroke, occlusive peripheral arterial disease) and/or type 2 diabetes mellitus with at least one other cardiovascular risk factor (hypertension, dyslipidemia, current smoking, or diabetic nephropathy). All patients underwent a 6-week lead-in period on Meridia 10 mg. Eligible patients were then randomized to either placebo or Meridia 10 mg daily. Titration to Meridia 15 mg daily was allowed for individuals with inadequate weight loss on 10 mg daily. The mean duration of exposure to Meridia and placebo was approximately 3.5 years.

There was a 16% increase in the relative risk of the primary outcome event (a composite of non-fatal myocardial infarction, non-fatal stroke, resuscitation after cardiac arrest, and cardiovascular death) in the Meridia group compared to the placebo group. There was no between-treatment difference in cardiovascular death or all-cause mortality . The primary outcome was driven by non-fatal myocardial infarction and non-fatal stroke.

The difference in mean percent change in body weight at Month 60, the end of the trial, between the Meridia and placebo groups was approximately 2.5%.

Subgroup analyses were also conducted on three defined cardiovascular risk groups composed of individuals with: (1) type 2 diabetes mellitus only; (2) a history of cardiovascular disease only; (3) a history of cardiovascular disease and type 2 diabetes mellitus. FDA’s analysis demonstrated that the logrank test interaction p-value for the cardiovascular risk subgroup analysis was 0.56, indicating that the magnitudes of risk for major adverse cardiac events in the three subgroups were not statistically significantly different.

Data from the SCOUT trial was discussed at the Endocrinologic and Metabolic Drugs Advisory Committee Meeting, held on September 15, 2010 (for complete safety reviews and background information discussed at this meeting go to www.fda.gov/AdvisoryCommittees ).

At this time FDA recommends that healthcare professionals:

  1. Stop prescribing and dispensing Meridia to patients.
  2. Contact patients currently taking Meridia and ask them to stop taking the medication.
  3. Inform patients of the risks associated with Meridia.
  4. Discuss alternative weight loss strategies other than Meridia with your patients.
  5. Be aware of the possible risk of major adverse cardiovascular events with patients taking Meridia and assess patients for these events if they present with any signs or symptoms of cardiovascular disease.
  6. Report any side effects with Meridia to FDA's MedWatch program at www.fda.gov/medwatch.

Thank you for listening. The FDA is committed to keeping healthcare professionals informed of the latest safety information. If you have questions about this safety communication, you can reach us at: druginfo@fda.hhs.gov.

 

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