FDA Drug Safety Communication: FDA Recommends Against the Continued Use of Meridia (sibutramine)
[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
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
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.
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
Additional Information for Patients
If you currently take Meridia, you should:
- Stop taking Meridia
and talk to your healthcare professional about alternative weight loss and weight loss management
- Talk to your healthcare professional if you have any concerns about
- Contact your healthcare professional right away if you experience pain in the
chest, heart palpitations, abnormal heart rate or rhythm, or other symptoms including dizziness and
- Dispose of unused Meridia in your household trash by following the
recommendations outlined in the Federal Drug
- 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.
any side effects with Meridia to FDA's MedWatch program using the information at the bottom of the
page in the "Contact Us" box.
Additional Information for
FDA recommends that healthcare professionals:
- Stop prescribing and dispensing Meridia to patients.
- Contact patients currently
taking Meridia and ask them to stop taking the medication.
- Inform patients of the risks
associated with Meridia.
- Discuss alternative weight loss strategies other than Meridia
with your patients.
- 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.
- Report any side effects with Meridia to
FDA's MedWatch program using the information at the bottom of the page in the "Contact Us"
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 kg/m2 and 45 kg/m2, or between 25 kg/m2 and 27 kg/m2 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 [Hazard Ratio (HR)=1.16; 95% CI, 1.03-1.31; p=0.02].
There was no between-treatment difference in cardiovascular death (HR=0.99; 95% CI, 0.82-1.19;
p=0.90) or all-cause mortality (HR=1.04; 95% CI, 0.91-1.20; p=0.54). The primary outcome was driven
by non-fatal myocardial infarction and non-fatal stroke (HR=1.28; 95% CI, 1.04-1.57; p=0.02;
HR=1.36; 95% CI, 1.04-1.77; p=0.03, respectively).
The difference in mean percent
change in body weight at Month 60 (end of the trial) between the Meridia and placebo groups was
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 see: September
15, 2010 AC meeting).