Abbott grudgingly pulls sibutramine off U.S. shelves
The withdrawal of sibutramine in the U.S. follows an 11-month process, beginning in November 2009, when Abbott promptly notified the FDA of the SCOUT (Sibutramine Cardiovascular OUTcome Trial) preliminary results immediately after receiving those results.
The FDA's request is based primarily on the results of the SCOUT study, an approximately 10,000-patient, six-year study requested by European regulatory authorities as a post-marketing commitment to evaluate cardiovascular safety in high-risk patients, according to Abbott. The majority of these patients had underlying cardiovascular disease and were not eligible to receive sibutramine under the current labeling, the company said.
In January, the European Medicines Agency suspended marketing authorization for all anti-obesity medicines containing sibutramine. Also in January, the FDA warned that a review of additional data indicates an increased risk of MI and stroke in patients with a history of cardiovascular disease using sibutramine.
The Abbott Park, Ill.-based Abbott provided a review of these analyses at the Sept. 15 public advisory panel with 16 experts selected by the FDA. That panel reviewed and debated the available data on sibutramine. The panel meeting concluded with 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. Abbott said the split decision reflects the "complexity of the scientific debate and the different interpretations of the data, even by independent experts."
Based on this decision, patients should discontinue use of sibutramine and consult their physician for alternatives.