الأربعاء, 23 أيار 2012 3. رجب 1433
An FDA advisory committee that convened to
discuss what changes to make to the marketing and sale of Abbott's Meridia (sibutramine) in the US has voted with a split result.
The panel voted 8-8 on a question of whether to allow the continued marketing of Abbott's Meridia amid study data suggesting that it increases heart attack, stroke and death risk.
European regulators banned the drug earlier this year.
In voting, six panel members called for a new boxed warning and restricted distribution of Meridia, and two panellists voted that a boxed warning alone would be sufficient.
No panellists voted for an option that called for no changes.
Commenting on the vote, panel member Eric Felner said "there is a fair amount of data that needs to be collected and we have physicians that do believe in this drug," adding that "it's safer in [physicians'] hands to give them the benefit of continuing to be able to use it."
Commenting on today's decision, Abbott VP of global pharmaceutical development, Eugene Sun, noted that "today's vote highlights the complexity of this scientific debate.
" He added that the company "continue[s] to believe that there are appropriate and identifiable patients that derive benefit from sibutramine [and] is an important option for patients and physicians to treat a serious condition for which there are few treatment options currently available."