obesity

Mysimba (Contrave-Naltexone plus bupropion in the EU) now approved for weight loss

Mysimba for weight loss- It is the name for Contrave (naltrexone and bupropion) in Europe. This drug is the newest weight loss drug and had an unusual release of data. What appears to be shown in early data is that it may have a direct effect/benefit in decreasing risk of heart attack.

Will lorcaserin (Lorquess) survive FDA scrutiny?

dr rybacki looking It's always difficult to predict how the FDA will perceive benefit to risk decisions and lorcaserin (Lorquess) is a singular example of this challenge. On one hand, the FDA has data showing that the medicine does work, while on th

Contrave and long wait for a new weight loss drug is probably over

food on plate The Endocrine and metabolic committee of the FDA recommended 13-7 to approve the first weight loss drug since 1999. Contrave (a combination of bupropion and naltrexone) was recommended for approval and while the FDA usually follows the vote of its expert committees, it is not bound to do so.

Contrave Controversy at the FDA

convention center The questions have been set for the Endocrine and Metabolic Advisory Committee meeting tomorrow and it looks like Contrave (bupropion plus naltrexone) will have some challenges facing benefits versus risks and may be required to have followup or additional studies performed.

Members Only: 

convention center The questions have been set for the Endocrine and Metabolic Advisory Committee meeting tomorrow and it looks like Contrave (bupropion plus naltrexone) will have some challenges facing benefits versus risks and may be required to have followup or additional studies performed.

The hint comes from the documents and questions which have been posted (www.fda.gov) in advance of the meeting and revolve around a 5% standard that the FDA requires as well as some blood pressure and mental status changes that emerged. The challenging situation for the FDA will be to think about the ramifications of asking for additional studies and side effect review as the two medicines in this combination pill are already FDA approved (naltrexone available as Revia and bupropion as Welbutrin). Would this mean that the existing drugs would also have to undertake such studies?

It's actually hard to tell what the decision will be, but it certainly should be an interesting meeting.

members circle The history in the FDA for weight loss medicines recently has been full of questions, rejections and even one removal (Meridia). Why the hard line? Risk to benefit considerations have been paramount since any approved medicine will be probably taken by a large number of people for a long period of time. Recent rejections include Qnexa and Lorqess and safety issues prompted an FDA review of sibutramine (Meridia) which was withdrawn from the market. Once again, it's important for the FDA to review medicines carefully--yet when a new medicine is made of two which are currently on the market, you would think that any FDA decision on the combination pill might effect the two separate ingredients. The meeting tomorrow should be complicated, yet perhaps patients struggling with significant weight issues may have a new treatment. See the agenda and pending questions at www.fda.gov

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