Weight loss drug pulled from market
October 8th, 2010
12:22 PM ET

Weight loss drug pulled from market

Abbott Laboratories has agreed to take its obesity drug Meridia (sibutramine) off the market, the U.S. Food and Drug Administration announced Friday.

The company voluntarily withdrew the drug because clinical trial studies showed there was an increased risk of heart attacks and strokes in people who used the drug.

Approximately 8 million people worldwide take the drug, the FDA said, including 100,000 Americans.

The drug had projected sales of $30 million in the U.S. in 2010, Abbott said.

"Meridia's continued availability is not justified when you compare the very modest weight loss that people achieve on this drug to their risk of heart attack or stroke,"  Dr. John Jenkins, M.D., director of the Office of New Drugs in the FDA's Center for Drug Evaluation and Research, said in a conference call Friday. "Physicians are advised to stop prescribing Meridia to their patients and patients should stop taking this medication. Patients should talk to their health care provider about alternative weight loss and weight loss maintenance programs."

Approved in 1997 for weight loss, the original data on the drug showed that people who took Meridia lost at least 5 percent more of their body weight than people who were on a placebo and relied on diet and exercise alone.

The FDA requested the company withdraw the drug, after reviewing data from a follow-up study known as the Sibutramine Cardiovascular Outcomes Trial (SCOUT ). It showed there was a 16 percent increase in the risk of serious heart events, including non-fatal heart attack, non-fatal stroke, and death, in a group of patients given Meridia as opposed to others given a placebo.

"In all its investigation of the drug, the FDA could find not one person whose benefit from the drug outweighed its risk," said Dr. Gerald Dal Pan, director of the Office of Surveillance and Epidemiology at the FDA’s Center for Drug Evaluation and Research.

soundoff (204 Responses)
  1. Aaron

    People are so sensitive, but there are several comments that are right. A pill wont do the job. Only exrcise and diet will. If those don't work, then the problem is you aren't truly motivated enough to make a real commitment to losing weight. Anabolic steroids (which the government and media hasve over demonized) are far safer in reasonable doses (doses that help lean and tone the body, not doses that a bodybuilder or baseball player would take) than these pills, and the effects are permanent.

    October 10, 2010 at 02:27 | Report abuse | Reply
    • Veggiehead

      Wrong on all counts, Aaron. Steroids are EXTREMELY dangerous. To say that they are "safer" than the appetite suppressant Meridia is to show that you don't know how steroids work on the body. And while the DAMAGE that steroids can do IS permanent, the effects that you consider positive (lean muscle mass, etc.) are NOT permanent! Stop taking the drugs, and your fat/muscle ratio will return to what is normal for you and your activity level. Of course, since you will probably continue to eat as ravenously as you did when on steroids, you will likely grow fat. And, of course, there is the withdrawl problem....

      October 11, 2010 at 04:04 | Report abuse |
  2. Carol

    Instead of looking for quick fixes, which don't exist, the drug companies try to find ways to make healthy food cheaper and more available? As someone who lost 50 pounds and has kept it off for years, I can tell you the only way to lose weight is to eat less calories and exercise regularly and you have to make those changes a permanent part of your life. A pill is not the answer or there would not be so many overwieght people.

    I do want to know why so many people on these sites can't comment on the issue without making some kind of political statement? People are overweight because of their poor diets and lack of exercise, not because of who is running the country!

    October 10, 2010 at 08:41 | Report abuse | Reply
  3. Carol

    Oops, I meant to say the drug companies should look for ways to make healthy food cheaper and more available, not that they already do......

    October 10, 2010 at 08:43 | Report abuse | Reply
  4. The_Mick

    I've lost 30 lbs and expect to lose another 30 by next Summer -which will get me below the "obesity" level on the BMI scale. Being a chemist, I knew better than to take any of these drugs – I'm modifying diet and exercise. The more involved in our bodies' biochemistry any drugs get, the greater the probability it will have unwanted effects. And getting to the energy-conversion/utilization level is pretty deep into our metabolism. Then Phen-Fen came out, a friend used it despite my trying to talk her out of it. Now she has to have her heart checked out every year.

    October 10, 2010 at 09:58 | Report abuse | Reply
  5. Constantine

    I guess people just cant poop more than they eat –
    it seems like simple math equation

    October 10, 2010 at 12:09 | Report abuse | Reply

    So there was never a clinical trial? SHort one...it must of kill or damage alot of people heart since there is no debate like plavix.

    Yes PLAVIX is a bad one...

    October 10, 2010 at 18:09 | Report abuse | Reply
  7. HJA

    Oh, and guess what? It's GOOD for drug companies to make a profit! You better hope they are profiteering, or you can kiss future medicines and drugs goodbye. Wow, profits, what a novel idea.
    October 8, 2010 at 13:56 "

    Yeah they spend a lot on development. Trouble is it's been proven they spend almost 2-1/2 times as much on advertising. You got an itch? They can give you a pill. You won't have to scratch!

    October 11, 2010 at 08:49 | Report abuse | Reply
    • scientist

      proven where? I sincerely doubt that claim. Do you know how much pharma spends on R&D?

      October 11, 2010 at 19:01 | Report abuse |
  8. acaidietsource

    I know there are some bad 'miracle pills' out there, but I am truly a believer in Colopure Cleanse
    ( http://www.channel6-news.com/health/ ) I started taking it mid-April and on the 5th of May I
    had lost almost 10lbs. Now, I had been watching my diet and exercising, but the immediate difference
    from Natural Colon Rescue was obvious. One of my problem areas is my
    belly, I was always bloated, feeling like I was about 9 months
    pregnant and honestly, I looked it too! After starting with the
    cleanse, my bloating went down in a week. I knew that I needed to
    cleanse, but this just reassured me that not only I needed to do so
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    satisfied and my skin was looking better – what an awesome way to feel!!!

    October 13, 2010 at 22:45 | Report abuse | Reply
  9. TheBlogger

    I have always had doubts about the effectiveness of the FDA. Why allow these companies to sell these drugs in the first place. the damage has been done.

    October 20, 2010 at 21:26 | Report abuse | Reply
  10. Leigh

    in defense of "fat people" not all of us got to the "overweight" status from sitting on our a**!! I am a mother to a 22 month old son, working full time, and going to college part time and found the scale slowing going up, so my doc suggested meridia to help me lose a few lbs due to sugar levels increasing (diabetes runs in my family–no they are not heavy people). So please tell me how in world do i find time to exercise and take care of MYSELF with no time or $$$ on my side??!!

    November 2, 2010 at 00:34 | Report abuse | Reply
  11. TK

    I am sick of Republicans complaining and making claims without ANY idea how to back themselves up or base anything on FACTS.
    Robert P. Watson, Ph.D. Coordinator of American Studies, Lynn University on Obama:
    "His first six months have been even more active than FDRs or LBJs the two standards for such assessments. Yet, there is little media attention given to much of what he has done. Of late, the media is focusing almost exclusively on Obama's critics, without holding them responsible for the uncivil, unconstructive tone of their disagreements or without holding the previous administration responsible for getting us in such a deep hole. The misinformation and venom that now passes for political reporting and civic debate is beyond description."
    "As such, there is a need to set the record straight. What most impresses me is the fact that Obama has accomplished so much not from a heavy-handed or top-down approach but from a style that has institutionalized efforts to reach across the aisle, encourage vigorous debate, and utilize town halls and panels of experts in the policy-making process. Beyond the accomplishments, the process is good for democracy and our democratic processes have been battered and bruised in recent years."

    November 19, 2010 at 13:26 | Report abuse | Reply
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