Posts tagged ‘Abbott Laboratories’

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.

Meridia – another diet drug being fed to the Advisory Committee

Abbott Laboratories drug Meridia will be discussed at a Sept 15, 2010 Advisory Committee Meeting.  This presents a significant challenge to Abbott.  They have data suggesting an increased risk of cardiovascular side effects with Meridia compared to placebo and have strengthened the Warnings section of the US package insert.  These risks however were troublesome enough to withdraw the drug from European markets. While Abbott will bring their best case to the Advisory Committee Meeting, it is difficult to think that the FDA will take a softer stand than Europe and allow the drug to remain on the market, especially when alternative treatment for obesity remains diet and exercise.  We think the Advisory Committee and the FDA will “push themselves away from the table” on this one.