overweight

Where's the beef? FDA rejects Contrave combination of two FDA approved medicines

two women angry IN a suprise move, the FDA decided against the advice of its own expert panel and apparently has postponed approval of the new weight loss drug called Contrave. The shocking aspect of this action is that Contrave is a combination of two medicines WHICH ARE ALREADY APPROVED BY THE FDA.

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Recent rejections include Qnexa and Lorqess and safety issues prompted an FDA review of sibutramine (Meridia) which was withdrawn from the market.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

National Weight Attack Day

Stop that weight attack !!!

seal

Nothing gets people moving like hearing that someone is having a heart attack. This is instantly recognized as a "gotta do something NOW" situation.

If I stood in the middle of a restaurant and shouted "I'm having a weight attack !!!" everyone would think I needed a psychiatrist.

Start Date: 
Wed, 09/08/2010

This website is not intended as medical advice, and you should consult your doctor before changing or adding any medicines or vitamins to those you may now be taking and about applying any strategies BEFORE you adopt any approach in this report. While diligent care has been taken to ensure the accuracy of the information provided during the preparation of this edition, no claim is made that all known actions, uses or side effects, strategies for cost containment, targets or cholesterol pathways are included in this report. The accuracy and currentness of information are ever subject to change relative to new guidelines, new information derived from drug research, development and general usage.