Abbott announced that it will voluntarily withdraw Meridia (sibutramine capsules) at the request of the FDA. Meridia is indicated as an adjunct to diet in the management of obesity in patients with initial body mass index ≥30kg/m2, or ≥27kg/m2 in presence of other risk factors. The FDA’s request to withdraw Meridia is based primarily on the results of the SCOUT (Sibutramine Cardiovascular OUTcome Trial) study, an approximately 10,000 patient, 6-year post-marketing study requested by European regulatory authorities to evaluate cardiovascular safety in high-risk patients. The majority of these patients had underlying cardiovascular disease and were not eligible to receive sibutramine under the current labeling.
The voluntary withdrawal of Meridia in the U.S. began in November 2009, when Abbott notified the FDA of the SCOUT preliminary results. Abbott submitted label changes to the FDA in January 2010 to further ensure appropriate use of Meridia based on the preliminary SCOUT findings. Additionally, Abbott conducted and provided analyses to the FDA for the purpose of determining the applicability of the SCOUT data to the approved on-label patient population. These analyses confirmed the appropriateness of the current label: that people with preexisting cardiovascular disease should not take the medication. These analyses also confirmed there was no excess risk in the approved patient population.
Abbott provided a comprehensive review of these analyses at the Septembsr 15, 2010 public advisory panel with 16 experts selected by FDA. The panel’s deliberations resulted in an 8-8 split decision with eight advisors voting in favor of enhanced labeling and risk management activities compared to eight advisors in favor of withdrawal. Ultimately, the decision made by the FDA was to withdraw Meridia from the U.S. market.
Patients should discontinue use of Meridia and consult their healthcare provider for alternatives.
For more information call (866) 257-8909 or visit www.sibutramine.com.