Meridia Recall

Meridia RecallAbbott has issued a Meridia Recall after being asked by the FDA to stop marketing the product in the United States due to results of a study indicating an increased risk of heart attack and stroke in Meridia users.

Meridia (sibutramine) is a prescription weight loss drug marketed and sold in the United Stages by Abbott Laboratories, who have removed their Meridia webpage and issued a Meridia recall statement on their website.

According to Abbott, he FDA’s request for Abbott to remove Meridia from the US market is based primarily on the results of the SCOUT (Sibutramine Cardiovascular OUTcome Trial) study. This study researched about 10,000 patient, 6-year study requested by European regulatory authorities as a post-marketing commitment to evaluate cardiovascular safety in high-risk patients. Abbot maintains that most of these patients “had underlying cardiovascular disease and were not eligible to receive sibutramine under the current labeling“.

Patients should stop using Meridia (sibutramine) and consult their physician. Patients can also contact Abbott’s medical information line at: 1-866-257-8909.

The 5-year study showed that the average difference in body weight between people on Meridia and those on a placebo was about 2.5%, yet there was a 16% increase in the risk of non-fatal heart attacks and non-fatal strokes. This apparent risk-to-benefit ratio was not acceptable to the FDA, prompting a request to Abbot that they should “voluntarily” recall Merida.

The FDA has an FYI/COB (For your information / Cover Our Butts) page up here if you would like to learn more about the Meridia recall and how it isn’t their fault. Abbott also has an FYI/COB (mostly COB) page up here.

The recall of Meridia comes after a major label update earlier this year, which required Abbott to include the following contraindication statement:

Meridia (Sibutramine) is not to be used in patients with a history of cardiovascular disease, including:

  • History of coronary artery disease (e.g., heart attack, angina)
  • History of stroke or transient ischemic attack (TIA)
  • History of heart arrhythmias
  • History of congestive heart failure
  • History of peripheral arterial disease
  • Uncontrolled hypertension (e.g., > 145/90 mmHg)

About

Everett Sizemore is the owner and Editor of US Recall News: http://www.usrecallnews.com. He is dedicated to educating people about consumer safety, social activism and corporate responsibility by bringing information to Americans about the products they use every day.

There are 23 comments. Add yours.

  1. ERF

    I still miss Meridia. I was very excited to hear bout Qsymia, but it’s side effects are SCARY. Meridia worked well for me, and I am so sad there are no alternatives on the market. I just keep my fingers crossed that Abbott labs will bring it (or something similar) back.

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  2. Melissa

    I took Meridia for almost 2 years and lost ALL my extra weight. I FINALLY felt and looks fabulously stunning, plus it boosted my happiness, all the pictures i have during taking this are of me smiling, laughing and looking great. Then all of a sudden i went to refill it in October and was told it was taken off the market. WHATT? What do i do now? I went cold turkey, Thanks pharmaceuticals. This is the only thing i found that helped me! I had been struggling with my weight since high school, and i’m now 32 years old & am 5’2″. I Lost about 45 pounds. I was asked to do some modeling which i did and look at the pics in amazement that that was even me. Now instead of being 109lbs like i was a year ago, i’m 125. I know it doesn’t sound like much but with my small frame it is a lot., and very noticeable and very frustrating and discouraging, wondering if the number will get higher and higher without meridia. Does anyone know if it will ever be back on the market? I haven’t found anything to replace it with have you? Oh and btw, i had open heart surgery, i have a cow aortic valve and NEVER NEVER EVER experienced flutters, high BP, etc while on meridia.

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  3. joanne

    i was taking meridia and i have high blood pressu\re, it lowered my blood pressure because i lost 52 pounds and i never felt better. it controlled my appetite which i needed in a very bad way. When they took it off the market my Dr put me on Adipex-p which is phetermine, it made me so nauseas and I felt extremely moody, just a horrible feeling all together and I didn’t loose any weight so this recall just doesn’t make any sense to me..

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  4. Raina

    I was taking meridia and nver had any problems with it. I really want them to bring it back. I was starting to lose weight and was at a better life style and now I am doing okay but with this drug it gave me the extra boost that I needed. I am also a celiac and it helped me balance out my nutrition.

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  5. Matt

    Does the Meridia recall involve any refunds to patients for unused product?

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  6. Wendy

    I took meridia for a year.I have no idea what the dosage was since it was in a diet pill I ordered online but I dind’ t know it was in there until after it was recalled. I had nothing but positive side effects. I lost 30 lbs in 6 months & kept it off. The weight loss was great, but the best part was an unexpected benefit. My mood was completely stabilized. I’ve battled bipolar for years & have tried many medications to stabilize my mood.That year was literally the best in my life. I was able to enjoy my life like like a normal person. I hadn’t ever felt that grounded before. I’m struggling now that the medicine is unavailable because the mood instability is back. I feel hopeless now that I’ve experienced a cure & it’s been taken away from me.My psychiatrist & I are working to find a medication that will bring the balance back. This would be much easier if meridia were still attainable.

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  7. ally

    i too am bummed about meridia. does anyone know how to get it in countries where its still legal? im worried about online orders that claim to be it…..its ridiculous that its being shoved off the market.

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  8. Samantha

    I have also taken Meridia without any problems. I am 22 years old, 5′ 1″, weighed 199 pounds, and had borderline high blood pressure when I began taking Meridia in the beginning of June. I had absolutely no problems. My blood pressure went down significantly. I’m not a “sweets” eater. My problem has always been portion control. By the time Meridia was taking off the market, I was down to 169 pounds in September. Of course, I also started exercising regularly, which contributed to my weight loss. Meridia not only gave me the “boost” that I needed to begin to lose weight and change my lifestyle to a healthier one, it gave me a big esteem boost as well. I have battled weight issues for all of my life, eventually wearing me down to the point of near depression. Being able to fit into clothes that I haven’t worn since high made me finally feel good about myself and my body image.

    I was near devastated when Meridia was taken off the market. Yes, I know that this was not a permanent solution, but I felt like 3 months was much too soon to abruptly stop taking the medication. And unfortunately portion control is my foe yet again. Have I gained a little weight back? Yes, 3 pounds. I am a graduate student with varying mealtimes after all. Have I changed my lifestyle? No. I still commit myself to the goals that I have set. But it is discouraging.

    For me, Meridia was beneficial. Of course, I carefully monitored my blood pressure. I also would like to reveal that I HAVE HEART MURMUR SINCE I WAS A BABY. And still, MERIDIA HAS HELPED ME TREMENDOUSLY WITH NO PROBLEMS. If I can monitor myself, anyone can. For those people who have had bad luck with this medication, it’s unfortunate, but if you were just plain careless, well thanks a lot for ruining it for those of us who it has really helped.

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  9. Shelly

    I have taken it for 2 years and no problems, now what am I suppose to take in place of it?

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  10. Jenny

    In addition, I’ve read up on Hoodia and it seems to have the same effect as Meridia, however, it will cost me 3 times as much. If anyone knows of another oral prescription alternative please e-mail me. I’m not interested in diet pills or fat blockers. I’m looking for something that actually changes brain chemistry. Anyone who has experienced this personally will know what I mean.

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  11. Jenny

    I have been on Meridia for 3 months and have lost 18 pounds. I am 43, 5’4, and was over 200 pounds. This drug has completely changed my brain chemistry to NOT LONG for food. At the itme I was prescribed this drug, I began eating heathier, more balanced meals. I HAVE NOT had any significant side effects. I’ve been on anti-depressants for the past 11 years. This drug not only helped with my mood, bu, as I stated, itt seemed to change my way of thinking about food. I now see it asfood as fuel, nothing more. I am NEVER hunger, nor do I OBSESS about food and what my next meal will be. Cravings are gone. It’s truly been a miracle. Now, sadly, it’s off the market. Too bad. Not sure what I’ll do now….

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  12. Needs Meridia

    As many have already testified, I am one of the 20% that lost significant weight AND felt the benefit of the product as an anti-depressant.

    Those times that I have stopped taking Meridia, I have gained weight and more importantly been heavily impacted by the pressures of life in general.

    I can’t believe that they are taking this product off the market because of the minute risk that it poses to those who at the mercy of physicians that aren’t able to execute due diligence.

    Bring Meridia Back!

    Reply
  13. Meridia fan

    I’ve been on Meridia much longer than suggested – about 2 years. To me it’s a wonder drug. I too lost a ton of weight. I’m only 5’2 but I gained 65 pounds when I quit smoking (and started eating instead).

    My heart raced for most of the first week, after that, it was fab. I actually called Abbott about 6 months in because my Dr. (since fired) was so opposed to my taking it. She said “it’s speed!” and I’m not prescribing it. I had to go in w/a stack of research to show that in fact, Meridia’s chemical composition is that of an SSRI – a serotonin reuptake inhibitor, ie, an anti-depressant! Who knew?

    I couldn’t figure out why mood was so much lighter, better. I wasn’t high, it’s like life didn’t seem so hard anymore. So they tested it as an anti-dep and they found that it worked on 20% (I think they said) but everyone lost weight. So they figured, they’d switch gears.

    I’m one of the 20%. Mood is up and weight is down. It’s a miracle drug. And, my blood pressure went down too! The doctor I had to fight to get a prescription, required that I come in once a week for first 3 months to have my blood pressure taken. And it was down every time.

    Yes, people with heart issues should not be taking sibutramine and there are plenty of other drugs they shouldn’t be taking either that aren’t being recalled. I think the biggest misconception, is that the weight loss is minimal. I’ve just read in another article it was an average of “5 pounds” weight loss?! I don’t know who they’re talking to but from all I researched of people taking it, the weight loss was much, much, more significant!

    It’s a shame to see it go. It can still be bought online w/out a prescription. Thank god! Otherwise this would be a true catastrophe because, as someone else noted, the negative side effects of obesity way out weigh the risks of Meridia.

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  14. Michael Issler

    Another example of big brother watching…..Listen if my insurance company helped with the cost of this medication and then stopped I could understand that, but this has been completely out of pocket for me. I don’t see tobacco and liquor companys recalling any of thier products and look at the health concern following these items!! So just like those products sales of Meridia should continue to those who want it….

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  15. Kellie

    I took a low dose Meridia for almost an entire month at the reccommendation of my general physician to jump start the loss of 40 lbs. She was aware that I have always had an arrhythmia.
    I lost 8 lbs…..but, my heart raced…I couldn’t sleep at night…and I found myself increasingly aggitated…with anything!
    Decided to do it the old fashioned way from that point on….healthy whole foods..and exercise!
    Feeling much better and saving the $125.00 that the medication cost/ month.

    Reply
  16. Claudia

    I have taken this drug for about 2 years stopped taking about a year in between, When I seen my PCP on 10/16/10 he informed me of the recall and asked me to stop taking it. I am concerned, unless you have a cardiologist see you, you really can not tell if Merida has affected your heart, only an echo and stress test will determine that, guess I am going to see a cardiologist very soon to make sure my heart is heathly.

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  17. amal

    I took this medication too. i havent had any issue i lost a lot of weight on it i was so much happier the only thing is i gained a lot more after getting off of them even still eating healthy. i

    Reply
  18. Margaret

    This product saved my life !!! I was able to lose 86 pounds over a 2 year period and have kept it off. It gave me the chance to learn a new lifestyle and become healthy. I was much more at risk for a heart attack carrying the extra weight. My doctor was fantastic and monitored me closley. I am so happy I had the opportunity to use this product before you yanked it off the market….

    Reply
  19. Heather

    I took this medication for a little over a year – NO PROBLEMS at all…

    Reply
  20. Jones

    I was taking this medication for several months and as well never had an increase blood pressure. In fact my blood pressure went down. I has helped my health considerably. The only issue i see is maybe with some doctors prescribing it inappropriately.

    Reply
  21. A Ochs

    Have you ever tried it or is this this just you opinion. Obesity gives you a lot more rists to your health than a 16% increase in heart disease. This product has helped me to become healthy and learn to eat properly more than anything on the market at this time. It has not increased my blood pressure, and has increased my health substantially. So now they decide I should no longer have the decision to take Medidia and remove it from the market. Based on one study -

    Reply

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