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September 15th, 2010
12:33 PM ET

FDA committee considers Meridia risks

Update: The FDA advisory committee has voted on Meridia with a split result (below).  The FDA will now take the advisory committee's recommendations into account and make a decision on what changes to make to the marketing and sale of Meridia in the U.S. market. 

Advisory committee vote

– 0 members: continued marketing with no changes
– 2 members: allow continued marketing and revise the current labeling to include a boxed warning about the increased risk for major adverse cardiac events and the need to closely monitor patients blood pressure, pulse and body weight
– 6 members: allow continued marketing and revise the current labeling to include a boxed warning and limit the use of Meridia through restricted distribution
– 8 members: withdrawal from the U.S. market

A Food and Drug Administration advisory committee is currently examining whether the diet drug Meridia should stay on the  market, amid concerns that it raises the risk of heart disease.

The drug, originally approved in 1997 was removed from the market in Italy in 2002 after several reports about its heart safety. It was re-released later that year, but only after a multi-national clinical trial was initiated to study the drug's risk profile.

According to briefing materials posted on the FDA's website, during the trial, the risk of heart attack and stroke in patients taking the drug was 11%, compared to a 10% risk in patients taking a placebo.

The drug's manufacturer, Abbott Labs, says the heart risks associated with Meridia in patients with a history of cardiovascular disease and patients whose blood pressure and pulse rise while taking the drug, is well documented.  Meridia's label clearly states that these at-risk patients should not take the drug, the company said.

The multi-national drug trial included mostly patients that fell into this high-risk category, in an effort to test the drugs safety in even the most risky population.

Hearings will continue throughout the day Wednesday, and committee members will conclude the session by voting on the drug's future – which could include removal from the market, inclusion of a black-box warning label for the drug, or no change at all to its current status.

 


soundoff (37 Responses)
  1. Sy2502

    One more indication that the best path to weight loss is still the good old fashioned diet and exercise.

    September 15, 2010 at 13:24 | Report abuse | Reply
    • CaliforniA

      It also is a good idea to cut out hormone-laden foods like cows milk and beef. We are ingesting the same drugs they use to beef up the cows and make them blubbery fat when we eat their meat. Stick with fish and hormone-free chicken.

      September 15, 2010 at 14:00 | Report abuse |
  2. Bzz

    What? Another drug put out by the pharmaceutical companies that does more harm than good? UNTHINKABLE!

    September 15, 2010 at 13:52 | Report abuse | Reply
  3. 12345

    They are using as human guinea pigs to see how far they can poison us. Millions die every year in America due to medication mismanagement on the part of the DOCTORS prescribing the wrong drug or too many dangerous combinations.

    There are countless natural remedies that do all of the same things as these horrific chemical concoctions do with almost no side effects. Read carefully though and use common sense like you would with anything else.

    September 15, 2010 at 13:54 | Report abuse | Reply
    • Greg

      its true. a doc put me on a cholesterol med and it did nt do anything. so i tried some flax seed because it is supposed to help that. i took it and two months later my cholesterol dropped 25 points! I couldnt beleive it!

      September 15, 2010 at 14:03 | Report abuse |
    • Bob

      Eat more Fresh veggies and fruits.. Drink plenty of water.. Walk or bike sometimes instead of driving.. Exercise 3-4 aweek.. Hey you are worth the time and effort!!

      September 15, 2010 at 17:37 | Report abuse |
  4. BeetleJuice

    I had horrible heartburn. I did not know why. I do not eat much spicy or fatty foods and I don't drink soda. I was put on heartburn meds which did NOT make me feel better but in fact made it worse. Heartburn meds are a cash cow for drug companies because they want you on them for life. I got off and my heartburn got WORSE! We NEED acids in our stomachs!

    Someone told me to try pure apple cider vinegar. I was of course skeptical but after a few days, it completely got rid of my reflux!I could not believe it. It costs like 6 bucks and I drink it with water each night and each morning. I cannot believe how much better I feel. Do not buy aciphex, or any of the other acid pills. It is all garbage. Read up on it to see how they REALLY work.

    September 15, 2010 at 13:58 | Report abuse | Reply
  5. DEBBIE ROSE

    MY MOM TOOK MERIDIA IN THE MID 90'S, HAVING HAD A HEART ATTACK IN 1991. THOUGH SHE WAS STABLE, THE MERIDIA PUT HER INTO A 3RD DEGREE HEART BLOCK, AND IT WAS IMMEDIATELY DISCONTINUED. HER DOCTOR KNEW IT WAS NOT INDICATED FOR PEOPLE WITH A HISTORY OF HEART ATTACKS, BUT DIDN'T THINK IT WOULD BE THAT RISKY. NO REAL HARM DONE, HEART RHYTHM RETURNED TO NORMAL. FAST FORWARD TO 2009, AND A DIFFERENT DOCTOR PUT MY MOTHER ON MERIDIA AGAIN. THIS TIME, MOM DIDN'T TELL ME AND AT 74, SHE DIDN'T REMEMBER THE EPISODE FROM THE 90'S. AND NOW MOM HAS A PACEMAKER/DEFIBRILLATOR IMPLANT FOR END STAGE HEART FAILURE. REMEMBER, THE BOX OF MERIDIA CLEARLY STATES DO NOT USE THE DRUG IF YOU HAVE HEART PROBLEMS OR HISTORY OF A HEART ATTACK. HER INTERNIST IS WELL THOUGHT OF AND I HAD NO IDEA SHE WAS TAKING THIS MEDICINE. SHE BEGAN COMPLAINING OF MULTIPLE SYMPTOMS, LIKE WEAKNESS, CONSTIPATION, AND DIZZINESS. AFTER WEEKS OF THIS, I GOT HER TO CONFESS SHE WAS ON MERIDIA. I DEMANDED SHE STOP, WHICH SHE DID. THEN, THE NEXT EVENING, HER DEFIBRILLATOR KICKED OFF WHEN SHE WAS WASHING THE DISHES IN HER KITCHEN. THE MERIDIA CHANGED HER HEART RHYTHM INTO ATRIAL FIBRILLATION, AND ULTIMATELY, SHE HAD SUDDEN DEATH AT HER KITCHEN SINK. THANK GOD FOR THE DEFIBRILLATOR, OR SHE WOULD HAVE DIED THEN AND THERE FROM THE MERIDIA. WE TOOK HER TO THE DOCTOR AND THEY ANALYZED THE DATA FROM THE PACEMAKER, SHOWING THE HEART RHYTHM CHANGING ABOUT THE TIME THE MERIDIA WAS STARTED. BECAUSE OF THE NEW HEART RHYTHM, SHE HAD TO BE PLACED ON BLOOD THINNERS. THIS LED TO HER HAVING BRUISES EVERYWHERE. THEN, THE SUNDAY BEFORE THANKSGIVING 2009, SHE FELL, AND BLED SO BADLY INTO HER BUTT AND HIP, SHE HAD TO BE HOSPITALIZED AND RECEIVE 4 PINTS OF BLOOD. NEARLY A YEAR LATER, SHE IS OFF THE BLOOD THINNERS AND OF COURSE THE MERIDIA AND IS DOING WELL, BUT BELIEVE ME, BEING 213 POUNDS AND 5FT 5 INCHES IS A LOT BETTER THAN BEING ON MERIDIA. IT IS NOT WORTH THE RISK. THE DRUG HAS TOO MANY SIDE EFFECTS AND ONCE IT IS STOPPED, THE WEIGHT RETURNS WITH LIGHTENING SPEED. I HOLD THE PHYSICIAN TOTALLY RESPONSIBLE AND HE KNOWS HE WAS WRONG TO PRESCRIBE IT, BUT WHAT IS DONE IS DONE. I THINK IT SHOULD BE REMOVED FROM THE MARKET.

    September 15, 2010 at 14:03 | Report abuse | Reply
    • Name2

      I am sorry to hear of your mother's severe health problems. Let it serve as a warning to those who are tempted by weight-loss drugs.

      Just to let you know, using all capital letters on the Internet is difficult to read and makes it look as if you are "yelling." Please type using normal print.

      September 16, 2010 at 10:48 | Report abuse |
  6. Venting

    This medication should/could be pulled off the market or at the very least a black box warning...The RISKS outweigh the BENEFITS and there are better options........This medication is just a clever advertising campaign and does not achieve the results it claims.Too many side-effects period.......................

    September 15, 2010 at 16:03 | Report abuse | Reply
  7. Leslie

    My grandmother always said that the best exercise for losing weight was "push-aways": Push yourself away from the table...

    September 15, 2010 at 16:06 | Report abuse | Reply
    • Name2

      Come on Leslie, we all know it is not that simple. Some people are unable to change the way the eat due to an inability to feel "full" and satisfied, intense food cravings, hormone imbalances, lack of nutritional education, emotional issues. Some do eat less and healthier and still do not lose any weight. Get off your high horse.

      September 16, 2010 at 10:50 | Report abuse |
  8. Bob

    Italy removed the drug in 2002! The FDA still considering?? I hope their is not a revolving door from FDA to CEO positions in Big Pharma???

    September 15, 2010 at 17:34 | Report abuse | Reply
  9. Bob

    I would try fish oil or flaxseed oil before trying these dangerous meds!! Is there a Holistic MD out there!! Holistic MD , thats an oxymoron( not oxycodin)...

    September 15, 2010 at 17:39 | Report abuse | Reply
  10. Wily Elder

    The FDA has safety as a low priority.

    September 15, 2010 at 20:09 | Report abuse | Reply
  11. Catharine

    During the study, how much weight was actually lost?

    September 15, 2010 at 20:21 | Report abuse | Reply
  12. Sara

    I think anyone who has half a brain is on to the FDA and big pharma! We will NOT be forced vaccinations, we don't have to take your stupid drugs, and we don't have to listen to your stupid recommendations! Their are drugs that are life saving at times that are a must, but the majority of your aliments can be cured without meds!!!

    September 16, 2010 at 10:02 | Report abuse | Reply
  13. Name2

    It would be wonderful if we could assist weight loss with a pill, but if it ever happens, it's going to have to be a natural substance of some kind, not a prescription chemical made in a lab. In the meantime, try to eat as many fresh, natural foods as you can and as few processed, sugary, salty foods as you can. Be active whenever possible, and enjoy life, no matter your size!

    September 16, 2010 at 10:52 | Report abuse | Reply
  14. Meridia

    I took meridia since last few years and lost 60+ pounds with it, no side effects ever. I never face any problem and no issue of heart attack with this medicine. I always buy meridia online from http://www.meridiaweightloss.info

    September 23, 2010 at 08:09 | Report abuse | Reply
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