Skip to content
  • About
  • Contact
  • Contribute
  • Book
  • Careers
  • Podcast
  • Recommended
  • Speaking
  • All
  • Physician
  • Practice
  • Policy
  • Finance
  • Conditions
  • .edu
  • Patient
  • Meds
  • Tech
  • Social
  • Video
    • All
    • Physician
    • Practice
    • Policy
    • Finance
    • Conditions
    • .edu
    • Patient
    • Meds
    • Tech
    • Social
    • Video
    • About
    • Contact
    • Contribute
    • Book
    • Careers
    • Podcast
    • Recommended
    • Speaking

Should the FDA have rejected Contrave?

Daniel J. Carlat, MD
Meds
April 13, 2011
Share
Tweet
Share

Recently, the FDA has rejected another anti-obesity drug, Contrave, because of concerns that it might cause heart attacks in patients who take it for years.

FDA’s excessive caution was motivated by its experience having been burned by the Fen-Phen fiasco. This was a weight loss drug widely prescribed in the 90s that was pulled from the market after studies showed it caused fatal lung and heart valve problems.

This new drug, however, is a combination of two medications that have already been widely prescribed and are fairly safe: Wellbutrin and naltrexone. Psychiatrists are familiar with both of them. We prescribe Wellbutrin for depression and smoking cessation, (and off-label for weight loss, for which it has shown efficacy as a stand alone), and we prescribe naltrexone for alcoholism.

As you can see from information published on Clinicaltrials.gov, Contrave is simply a combination of Wellbutrin 400 mg with Naltrexone at a couple of different doses, 48 mg and 16 mg. Clinical trials showed that Contrave helped 50% of obese patients lose 5% of their body weight, while only 10% of patients on placebo lost that much weight. The FDA’s advisory panel voted to recommend approval, but the FDA demurred, saying that the company, Orexigen, will have to conduct a huge placebo-controlled long term study to make sure the drug doesn’t cause heart attacks (one of Wellbutrin’s well-known side effects is a slight increase in pulse and blood pressure, although there were no heart attacks in the Contrave clincial trials).

In my opinion, the FDA made the wrong decision. Obesity is a public health catastrophe, and Contrave’s approval would have been predicated on conducting post-marketing safety studies anyway. The good news is that patients can ask doctors to prescribe them the constituents of Contrave, both of which are available in generic form–burpropion and naltrexone. Presumably, this generic combination will be much cheaper than Contrave’s pricing anyway.

Daniel Carlat is a psychiatrist and author of Unhinged: The trouble with psychiatry- a doctor’s revelations about a profession in crisis.

Submit a guest post and be heard on social media’s leading physician voice.

Prev

USA Today op-ed on end of life care and advance directives

April 13, 2011 Kevin 1
…
Next

Policies prohibiting collaboration between physicians and industry

April 13, 2011 Kevin 3
…

Tagged as: Medications

Post navigation

< Previous Post
USA Today op-ed on end of life care and advance directives
Next Post >
Policies prohibiting collaboration between physicians and industry

ADVERTISEMENT

ADVERTISEMENT

ADVERTISEMENT

More by Daniel J. Carlat, MD

  • a desk with keyboard and ipad with the kevinmd logo

    Elimination of industry support for CME

    Daniel J. Carlat, MD
  • a desk with keyboard and ipad with the kevinmd logo

    The decision point psychiatrists faced with psychotherapy

    Daniel J. Carlat, MD
  • a desk with keyboard and ipad with the kevinmd logo

    ProPublica’s Dollars for Docs: Strengths and weaknesses

    Daniel J. Carlat, MD

More in Meds

  • A world without antidepressants: What could possibly go wrong?

    Tomi Mitchell, MD
  • The truth about GLP-1 medications for weight loss: What every patient should know

    Nisha Kuruvadi, DO
  • The hidden bias in how we treat chronic pain

    Richard A. Lawhern, PhD
  • Biologics are not small molecules: the case for pre-allergy testing in an era of immune-based therapies

    Robert Trent
  • The anesthesia spectrum: Guiding patients through comfort options in oral surgery

    Dexter Mattox, MD, DMD
  • Functional precision oncology: a game changer in cancer therapy

    Chris Apfel, MD, PhD, MBA
  • Most Popular

  • Past Week

    • What’s driving medical students away from primary care?

      ​​Vineeth Amba, MPH, Archita Goyal, and Wayne Altman, MD | Education
    • Make cognitive testing as routine as a blood pressure check

      Joshua Baker and James Jackson, PsyD | Conditions
    • The hidden cost of delaying back surgery

      Gbolahan Okubadejo, MD | Conditions
    • The dreaded question: Do you have boys or girls?

      Pamela Adelstein, MD | Physician
    • Rethinking patient payments: Why billing is the new frontline of patient care [PODCAST]

      The Podcast by KevinMD | Podcast
    • The broken health care system doesn’t have to break you

      Jessie Mahoney, MD | Physician
  • Past 6 Months

    • What’s driving medical students away from primary care?

      ​​Vineeth Amba, MPH, Archita Goyal, and Wayne Altman, MD | Education
    • What happened to real care in health care?

      Christopher H. Foster, PhD, MPA | Policy
    • Internal Medicine 2025: inspiration at the annual meeting

      American College of Physicians | Physician
    • The hidden bias in how we treat chronic pain

      Richard A. Lawhern, PhD | Meds
    • A faster path to becoming a doctor is possible—here’s how

      Ankit Jain | Education
    • Residency as rehearsal: the new pediatric hospitalist fellowship requirement scam

      Anonymous | Physician
  • Recent Posts

    • How scales of justice saved a doctor-patient relationship

      Neil Baum, MD | Physician
    • Rediscovering the soul of medicine in the quiet of a Sunday morning

      Syed Ahmad Moosa, MD | Physician
    • An introduction to occupational and environmental medicine [PODCAST]

      The Podcast by KevinMD | Podcast
    • Does silence as a faculty retention strategy in academic medicine and health sciences work?

      Sylk Sotto, EdD, MPS, MBA | Conditions
    • Why personal responsibility is not enough in the fight against nicotine addiction

      Travis Douglass, MD | Conditions
    • How dismantling DEI endangers the future of medical care

      Shashank Madhu and Christian Tallo | Education

Subscribe to KevinMD and never miss a story!

Get free updates delivered free to your inbox.


Find jobs at
Careers by KevinMD.com

Search thousands of physician, PA, NP, and CRNA jobs now.

Learn more

View 6 Comments >

Founded in 2004 by Kevin Pho, MD, KevinMD.com is the web’s leading platform where physicians, advanced practitioners, nurses, medical students, and patients share their insight and tell their stories.

Social

  • Like on Facebook
  • Follow on Twitter
  • Connect on Linkedin
  • Subscribe on Youtube
  • Instagram

ADVERTISEMENT

ADVERTISEMENT

ADVERTISEMENT

ADVERTISEMENT

  • Most Popular

  • Past Week

    • What’s driving medical students away from primary care?

      ​​Vineeth Amba, MPH, Archita Goyal, and Wayne Altman, MD | Education
    • Make cognitive testing as routine as a blood pressure check

      Joshua Baker and James Jackson, PsyD | Conditions
    • The hidden cost of delaying back surgery

      Gbolahan Okubadejo, MD | Conditions
    • The dreaded question: Do you have boys or girls?

      Pamela Adelstein, MD | Physician
    • Rethinking patient payments: Why billing is the new frontline of patient care [PODCAST]

      The Podcast by KevinMD | Podcast
    • The broken health care system doesn’t have to break you

      Jessie Mahoney, MD | Physician
  • Past 6 Months

    • What’s driving medical students away from primary care?

      ​​Vineeth Amba, MPH, Archita Goyal, and Wayne Altman, MD | Education
    • What happened to real care in health care?

      Christopher H. Foster, PhD, MPA | Policy
    • Internal Medicine 2025: inspiration at the annual meeting

      American College of Physicians | Physician
    • The hidden bias in how we treat chronic pain

      Richard A. Lawhern, PhD | Meds
    • A faster path to becoming a doctor is possible—here’s how

      Ankit Jain | Education
    • Residency as rehearsal: the new pediatric hospitalist fellowship requirement scam

      Anonymous | Physician
  • Recent Posts

    • How scales of justice saved a doctor-patient relationship

      Neil Baum, MD | Physician
    • Rediscovering the soul of medicine in the quiet of a Sunday morning

      Syed Ahmad Moosa, MD | Physician
    • An introduction to occupational and environmental medicine [PODCAST]

      The Podcast by KevinMD | Podcast
    • Does silence as a faculty retention strategy in academic medicine and health sciences work?

      Sylk Sotto, EdD, MPS, MBA | Conditions
    • Why personal responsibility is not enough in the fight against nicotine addiction

      Travis Douglass, MD | Conditions
    • How dismantling DEI endangers the future of medical care

      Shashank Madhu and Christian Tallo | Education

MedPage Today Professional

An Everyday Health Property Medpage Today
  • Terms of Use | Disclaimer
  • Privacy Policy
  • DMCA Policy
All Content © KevinMD, LLC
Site by Outthink Group

Should the FDA have rejected Contrave?
6 comments

Comments are moderated before they are published. Please read the comment policy.

Loading Comments...