FDA KOs another weight loss drug

Bottom line:  despite the risks of obesity, the FDA is concerned about the possible safety risks of a drug that people might take every day for the rest of their lives.

Back to basics!  More activity; more sleep; more veggies; less sugar; less prepared food…

From the Wall Street Journal:

And Orexigen’s Contrave Makes 3: FDA Rejects (Another) Diet Drug

The FDA said it wouldn’t consider approving the experimental weight-loss drug Contrave without another clinical trial, says the drug’s developer, Orexigen Therapeutics.

Such a trial — to demonstrate that the drug doesn’t raise the risk of heart attack or stroke — would likely be lengthy and expensive. The decision comes after an FDA advisory panel voted in December to recommend approval of the drug.

Health Blog readers, given all this, when do you expect a new weight-loss drug to hit the U.S. market?

Dr John Ellis MD

Board-certified anesthesiologist, with expertise in cardiovascular anesthesia and the implications of obesity and sleep apnea in anesthesia. See vascularanesthesia.com for professional information. Dr. Ellis has used the strategies in here to: (1) lose 120 lbs over 18 months, (2) stop all antihypertensive medicines, and (3) no longer need CPAP treatment for sleep apnea.

One Comment:

  1. From heartWire http://goo.gl/ma2zv:
    “Early Tuesday morning, the company issued a statement noting that the FDA had issued a “complete-response” letter for the Contrave new drug application yesterday, the deadline for the Prescription Drug User Fee Act action date. In it, the statement reads, “The FDA noted concern about the cardiovascular safety profile of naltrexone/bupropion when used long-term in a population of overweight and obese subjects. Specifically, the letter stated that ‘before your application can be approved, you must conduct a randomized, double-blind, placebo-controlled trial of sufficient size and duration to demonstrate that the risk of major adverse cardiovascular events in overweight and obese subjects treated with naltrexone/bupropion does not adversely affect the drug’s benefit/risk profile.’ “”

Comments are closed