SCOUT (Sibutramine Cardiovascular OUTcome Trial) study, 6-year study requested by European regulatory authorities as a post-marketing commitment to evaluate cardiovascular safety in high-risk patients, is the basis for FDA’s request to recall the product.
The study showed that the majority of these patients had underlying cardiovascular disease and were not eligible to receive sibutramine under the current labeling.
Abbott said that the SCOUT results are in contrast to the vast body of Sibutramine data for the on-label patient population, including 46 controlled clinical trials and more than 6m patient years of use accumulated over 13 years during which the product has been available.
Reportedly, these data fail to confirm the excess cardiovascular risk found in the SCOUT study.
The voluntary withdrawal of Sibutramine in the US follows an 11-month process, beginning in November 2009, when Abbott promptly notified FDA of the SCOUT preliminary results immediately after receiving those results.
The European Medicines Agency (EMA) suspended marketing authorisation for all anti-obesity medicines containing Sibutramine in January 2010.
Abbott submitted label changes to FDA in January 2010 to further ensure appropriate use of the product based on the preliminary SCOUT findings.
Abbott claimed that it has conducted and provided numerous analyses to FDA and other regulatory authorities for the purpose of determining the applicability of the SCOUT data to the approved patient population, which confirmed the appropriateness of the current label, that people with preexisting cardiovascular disease should not take the medication.
Abbott cautioned the patients to discontinue use of Sibutramine and consult their physician for alternatives.
Additionally, Abbott is having ongoing discussions with regulatory authorities in countries where Sibutramine is marketed and anticipates concluding those discussions in the coming days.