Posts tagged ‘sibutramine’

Meridia – Advisory Committee Meeting Sept 15, 2010

Another diet drug with cardiovascular problems, another Advisory Committee Meeting, only this time it’s not a case of getting the drug on the market.  For drug maker Abbott, it’s a question of whether their data is strong enough to convince the Advisory Committee to recommend something other than withdrawal, one of 4 options the FDA has posed to the Committee.  At the other end of the option spectrum of questions, the Committee could choose that the drug is safe, effective and the package insert as it is currently written is adequate.  This is unlikely.  Data suggests a cardiovascular problem and problems don’t go away if you keep doing the same thing.  Ask Tiger Woods.  Eventually you’re going to run into a tree.
 
We’ve said it before, obesity generally presents with co-morbidities of cardiovascular problems, diabetes, respiratory etc.  It’s part of the package.  When there is a cardiovascular signal, we don’t think you can adequately provide labelling in a big enough black box that defines the patients at risk to the degree of confidence that will make the FDA comfortable with any of these drugs.  We think this is a close call between asking the company to produce a REMS program that provides this extra help for the prescribing physician or withdrawing the drug, i.e, limited distribution or no distribution.