Meridia Recall Issued Due to Heart Attack And Stroke Risks

Federal regulators have decided that the weight-loss drug Meridia is too dangerous to stay on the market, due to the risk of heart attack and stroke. 

The FDA announced a Meridia recall today, calling on Abbott Laboratories to pull the drug from shelves. FDA officials said that the side effects of Meridia, which has been linked to an increased risk of cardiovascular problems, combined with very little actual weight loss benefits, made giving the drugs to consumers unjustified.

The decision comes after a nearly year-long FDA safety review which culminated in September with a split decision by an FDA advisory committee on whether the drug should be recalled or not. There has already been a recall of Meridia issued in Europe, which occurred shortly after a research report, known as SCOUT (Sibutramine Cardiovascular Outcomes Trial), was published. The same report led the FDA to start its safety review.

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Meridia (sibutramine), which is manufactured by Abbott Laboratories, was approved by the FDA in 1997 as a prescription-only weight loss supplement for obese patients with other risk factors such as diabetes, high cholesterol and controlled blood pressure.

Last month, Abbott Laboratories attempted to convince the FDA advisory panel to use sales restrictions and warnings instead of banning the drug. But the company no longer actively promotes the medication in the United States and only had $30 million in domestic sales last year. Globally, the drug brought in about $100 million. However, the Meridia recall could make the company more vulnerable to potential Meridia lawsuits.

Researchers conducting SCOUT found that Meridia increased the risk of serious heart events, such as heart attacks and strokes, by 16%, while finding only a small difference in the weight loss between people given Meridia and those given a placebo. The FDA said that the SCOUT data and the agency’s subsequent review led it to the decision to ask Abbott Laboratories to voluntarily remove Meridia, which it agreed to do.

The recall coincided with a FDA drug safety communication released today that recommended against the continued use and prescription of Meridia.

“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,” said Dr. John Jenkins, the FDA’s director of the Office of New Drugs. “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.”

Abbott Laboratories released a press release saying that the company disagreed with the FDA’s position, but would comply. The company said that the SCOUT results conflicted with numerous other Meridia drug trials which did not find heart problems.

Some consumer advocate groups have been calling for a recall of Meridia for years. In December 2009, Public Citizen petitioned the FDA to recall Meridia due to the SCOUT trial findings. It is the second time the non-profit has asked the FDA to take Meridia off shelves. The first petition, filed in 2002, was denied by the FDA. The drug is listed as a “Do Not Use” drug on the Public Citizen’s “Worst Pills, Best Pills” list.

9 Comments

  • KKFebruary 22, 2011 at 12:48 am

    I have taken Meridia on and off since the drug came on the market in 1997. I have used it to maintain a healthy weight all through my perimenopausal/menopausal transition. Not only was I able to maintain a good healthy weight, I experienced NO bad side effects, NO heart or BP issues, and I appreciated that it was a slight mood elevator. I have never been an obese person and have always been moni[Show More]I have taken Meridia on and off since the drug came on the market in 1997. I have used it to maintain a healthy weight all through my perimenopausal/menopausal transition. Not only was I able to maintain a good healthy weight, I experienced NO bad side effects, NO heart or BP issues, and I appreciated that it was a slight mood elevator. I have never been an obese person and have always been monitored by my physician. I am very saddened that this drug has been removed by the FDA. I suspect that the SCOUT study missed counting people like me in their data compilation!!! I wish Abbot Laboratories could continue to sell this drug.

  • BrendaNovember 24, 2010 at 9:09 pm

    I was on Meridia for 2 yrs. I lost 35 pounds (my desired weight loss goal). I am on medication for high blood pressure and also have a history of cardiac arrest 10 yrs ago. While on Meridia I had no increase in blood pressure or other symptoms. I was being monitored by my cardiologist. I have not gained my weight back in the two years I have been off the medication. I regret Meridia has been taken[Show More]I was on Meridia for 2 yrs. I lost 35 pounds (my desired weight loss goal). I am on medication for high blood pressure and also have a history of cardiac arrest 10 yrs ago. While on Meridia I had no increase in blood pressure or other symptoms. I was being monitored by my cardiologist. I have not gained my weight back in the two years I have been off the medication. I regret Meridia has been taken off the market as it can be of value for people who need to lose weight for health reasons.

  • CCNovember 19, 2010 at 2:03 am

    I have been taking Meridia since 2006,little weight loss 35 pounds.In 2008, I did have a Stroke and was paralized on complete left side of my body,I was lucky with no side effects.I had to email my Doctor when I heard of the recall and asked should I get off,,now I'm wondering if this medication indeed have anything to do with my stroke.I will be investigating this.

  • LoriNovember 7, 2010 at 12:15 am

    I have been on Meridia for over a year and it the first drug that has controlled my appetite with absolutely NO side effects. The weight loss is slow and constant as recommended by all weight loss programs, and I have no cardiac issues. I also happen to be a Registered Nurse and keep up with many pharmaceutical updates. I think the reason behaind the recall is the minimal profit the drug company m[Show More]I have been on Meridia for over a year and it the first drug that has controlled my appetite with absolutely NO side effects. The weight loss is slow and constant as recommended by all weight loss programs, and I have no cardiac issues. I also happen to be a Registered Nurse and keep up with many pharmaceutical updates. I think the reason behaind the recall is the minimal profit the drug company must be making due to low sales. I believe it's quite possible these cardiac events were probably inevitable because of the primary problem - OBESITY. I am very upset about the drug being taken off the market.

  • AnneNovember 5, 2010 at 1:46 am

    My friend aged fifty started taking Meridia last spring after a friend raved about how well it worked for him. Its been less than six months, and she's lost about twenty pounds. She and has recently suffered two cardiac events in the past five weeks and is suffering with an erratic heartbeat, low blood oxygen levels and uncontrollable bloodpressure. She spent the weekend wearing a heart monitor[Show More]My friend aged fifty started taking Meridia last spring after a friend raved about how well it worked for him. Its been less than six months, and she's lost about twenty pounds. She and has recently suffered two cardiac events in the past five weeks and is suffering with an erratic heartbeat, low blood oxygen levels and uncontrollable bloodpressure. She spent the weekend wearing a heart monitor and feels like in her words 'someone is throwing bricks at her chest'. She has been advised that she may need a pacemaker. Previous to taking the Merida, she had no cardiovascular, heart problems. Glad you guys had such a great result but my friend is........now. I think you can read between the lines

  • BeverleyNovember 4, 2010 at 5:51 pm

    I started taking Meridia 2 years ago and lost 55 lbs in a little less then 1 year. I decided to stop & rapidly regained most of the weight. I started again 3 months ago and am on my way to loosing it again, only to be told I can not continue. I hope that the recall will be cancelled and more confidence be put on our doctor's expertise.

  • JoyOctober 15, 2010 at 7:21 pm

    I started taking Meridia in May and have lost 50lbs to date. I am very very sad this drug is no longer available. I have another 50lbs to lose and 'was' well on my way to my weight goal. I do not have a history of heart problems and this is devestating to me. Nothing else, including exercise has worked to get the weight off. I guess this non-profit group knows better than me and my doctor wh[Show More]I started taking Meridia in May and have lost 50lbs to date. I am very very sad this drug is no longer available. I have another 50lbs to lose and 'was' well on my way to my weight goal. I do not have a history of heart problems and this is devestating to me. Nothing else, including exercise has worked to get the weight off. I guess this non-profit group knows better than me and my doctor what is 'good' for me. I will likely gain all of the weight back and then some! My general health has improved and the cost of treating my other obesity related health issues declined - i.e. no joint pain... How unfortunate for those of us who found this drug helpful!!!

  • AnneOctober 14, 2010 at 10:34 pm

    I have been taking Meridia for about 1 year and have lost about 45 lbs. I have found that when I had to wait for my insurance to authorize the perscription refill and was off of it for about 2 weeks I gained 10 lbs. back very fast. I did not have any side effects from the medication. I have used Meridia as a helpful tool along with watching my diet. I am sorry that Meridia has to be taken off of [Show More]I have been taking Meridia for about 1 year and have lost about 45 lbs. I have found that when I had to wait for my insurance to authorize the perscription refill and was off of it for about 2 weeks I gained 10 lbs. back very fast. I did not have any side effects from the medication. I have used Meridia as a helpful tool along with watching my diet. I am sorry that Meridia has to be taken off of the market.

  • KeithOctober 13, 2010 at 11:59 am

    I've been taking Meridia for just over two years and have lost a total of 130 pounds. The only side effect I've noticed (and I'm quite sensitive to all medications...including Niacin) is a very slight elevation in mood. My cardiologist told me last month "You are in the top 1% of cardiac recovery patients"..."You could serve as the poster boy for cardiac recovery"..."You will not have another he[Show More]I've been taking Meridia for just over two years and have lost a total of 130 pounds. The only side effect I've noticed (and I'm quite sensitive to all medications...including Niacin) is a very slight elevation in mood. My cardiologist told me last month "You are in the top 1% of cardiac recovery patients"..."You could serve as the poster boy for cardiac recovery"..."You will not have another heart attack". I started my diet at 338.5 lbs., lost 3/4 of a pound a day during the first 6-8 months, and am now within 10 lbs. of my ideal target weight. Meridia has been a God send for me...I'm sorry they've decided to take it off the market.

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