New Diet Pill In Question

NEW YORK — Editors of a top medical journal call Meridia "another flawed diet pill" and question whether it should stay on the market as a study shows it raises the risk of heart attack and stroke in people with heart problems.

The strongly worded editorial comes two weeks before government advisers review the prescription drug, which has already been pulled in Europe. In January, U.S. drug regulators strengthened existing warnings that the appetite suppressant should not be used by those with a history of heart trouble.

In Thursday's issue, the editors of the New England Journal of Medicine noted that the latest study showed weight loss with Meridia was minimal, it didn't improve cardiovascular health, and those with heart disease fared worse.

"It is difficult to discern a credible rationale for keeping this medication on the market," they wrote.

The editorial – with a headline calling the drug "another flawed diet pill" – was published along with the findings of the study conducted in Europe, Latin America and Australia.

The research involved about 10,700 overweight or obese people 55 or older who had heart disease, diabetes or both and were treated for about 3 1/2 years.

Overall, 11.4 percent of those on the diet pill had a heart attack, stroke or died of a heart-related cause, compared to 10 percent of those taking a dummy pill. The difference was mostly in heart attack and stroke; there was no difference in deaths between the groups.

A person taking Meridia had a 1-in-70 chance of suffering a heart attack or stroke, or a 1-in-52 chance if they had pre-existing heart problems, the editors wrote.

There was no increased risk in the group with diabetes but no heart problems, the researchers found.

Meridia also led to only modest weight loss: about 10 pounds over 12 months for someone weighing an average of 211 pounds.

The research, requested by European drug regulators, was funded by Meridia maker Abbott Laboratories, and company employees were among the researchers. After getting preliminary results, the European Medicines Agency recommended in January that the diet pill no longer be sold in Europe and Abbot suspended sales. The U.S. Food and Drug Administration sought the stronger label warnings.

Abbott spokesman Scott Davies said the appropriate candidate for Meridia is someone who's obese with no history of heart disease who can't lose weight with diet and exercise. He noted that most of the study's participants wouldn't be eligible to take it under its current label.

"We believe this is an important option for patients and physicians to treat a serious condition for which there are few treatments currently available," he said.

Meridia was approved in the U.S. in 1997 – the same year the popular fen-phen drug combo was linked to heart valve problems and pulled from the market. Meridia use in the U.S. has been steadily declining in recent years, according to prescription data firm IMS Health. About 283,000 prescriptions for it were filled last year, just over half the number of prescriptions in 2005.

Davies said Abbot doesn't actively promote Meridia in the U.S. and he termed sales modest. The company expects global sales this year to be less than $100 million, including less than $30 milllion in the U.S., he said.

The drug, also known as sibutramine, is sold under a variety of names around the world.

An FDA advisory panel will review the study at a Sept. 15 meeting, while the next day it will consider approval of a new weight-loss drug, lorcaserin. Drugmakers have struggled to come up with a pill that doesn't have risky side effects. The panel voted against another experimental diet drug in July because of its side effects.

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Online:

New England Journal: http://www.nejm.org

Comments

[krissymax]

12:57 PM on 09/06/2010

Another horrible drug from Abbott Labs - see also Lupron Depot. Same type of issues as Meridia. Very little efficacy and a huge amount of risk. FDA is just so poor at their job you really can't ever trust them to do what is in the public's best interest. Concerning the Avandia nightmare, Time Magazine's title to their article was "Is FDA on Drugs?" When someone asks this question about you or your agency - I think it is time for change and you have NO credibility.

[thecoffeegod]

11:20 AM on 09/04/2010

Sweeping 'F@t people are just...' comments begin in 3

2

1.......

[Marcus L Wells]

03:26 PM on 09/03/2010

Controversy has erupted again with weight loss drugs. Earlier this year we saw the FDA not give full approval for Qnexa a combination of phentermine and an epilepsy drug. But, an old "friend" Meridia also known as sibutramine,the cousin isomer ( D-dexfenfluramine) to D-dexfenfeluramine(DF). Sound familiar? The DF cousin was used in the controversial combination with phentermine in the 1990s. This combination caused one of the largest drug recalls in USA history after idiopathic pulmonary fibrosis and left ventricular problems were noted with users of the combination.As a result phentermine and dexfenfluramine were not to be used in combination. The new isomer Sibutramine later marketed as Meridia tauted as the new safer appetite suppresant was marketed. But, the study funded by Abbott lab with the European Medicine Agency found an increase(albiet small) risks in heart disease and stroke has called Meridia to be "pulled" from drug stores.Though the FDA hasn't followed in suit it is endorsing the stronger warning label. But, This demonstrates more of a need to approach weight loss as one aspect of a healthy lifestyle and that only with fitness, nutritional support, behavior modification/motivation and prevention education can we create a "culture of wellness". This drug recall is quickly on the heels of the FDA'S review of another drug called Lorcaserin. We put too much emphasis on drugs as the "magic bullet" when it really takes the multi-approach explained. Drugs can be helpful with dangerously high BMIs.

[alieninvader]

09:17 AM on 09/03/2010

This highlights the problem with American's view toward weight and weight loss. Quick (or in this case not so quick) fix pills wouldn't be on the market if our society emphasized the health implications of weight over the cosmetic. We scorn the drug problems of Lindsey Lohan and Paris Hilton, but I believe that even they are looked at as being more in control than the morbidly 0bese woman riding the cart through the grocery store. Why? Because they look good being out of control.

For most people, regardless of size, a modest 10% loss of body weight can make dramatic improvements on health. Improvements in diet or exercise habits can make big differences, even with no resulting weight loss (yes, it's possible to eat too many healthy calories). The problem is, our society doesn't appreciate modest changes. We look for the extreme makeover. For a 300 lb person, the idea of losing half their body weight seems insurmountable, yet their efforts seem not to matter until they do just that.

Addictive behavior is bad for individuals and bad for society, yet we live unaware of most of our neighbors' and coworkers' addictions. 0verw.eight people have the misfortune of wearing theirs on the outside. Doubly unfortunate for them is that they can't stop eating cold turkey, no matter how much people have tried. Their triggers are everywhere.

[Militant Leftist]

06:56 AM on 09/03/2010

Forget the pills, forget the latest fad diet. There is one formula for weight loss and that is burning more calories than what are taken in, on a daily basis. You accomplish this by eating fruits and vegetables, smaller portions, avoiding high calorie foods, and exercising 30 - 60 minutes per day.

[HorseChowda]

03:42 PM on 09/02/2010

Diet pills are a good example of why there is such a health crisis in the first place. Everyone knows what you need to do to be healthy: eat right and exercise. In fact this can reverse many of the problems that come with being overweight and unhealthy. But, nobody wants to make the changes and commit themselves to living a healthy lifestyle. It has to involve zero effort, zero commitment, but show extraordinary results.

A co-worker told me just last week that her neighbor, who was diagnosed with type 2 diabetes, didn't feel like she needed to change her diet because "the pills will control my insulin". She had knee replacement surgery as well, but didn't feel like she needed to lose weight "because they gave her new knees". There is such a culture of apathy towards health today, when in fact there are few things in life that should be given as much care and attention.

[Josephius]

02:21 PM on 09/02/2010

As far a obesity pills go...it is the grave yard of drug development. The issues that kill them are related to safety.

It's important to understand that the mechanisms of action (how they work) for all of these drugs are very different. Just because some have problems doesn't mean that others will have those same problems.

The review for locaserin will take place on Sept 16th. Although not potently efficacious, it does have an impressive safety profile. After review of the available information so far, I believe it will be approved.

Their is a huge unmet demand for obesity treatments. Expect other companies/researchers to continue to look for ways to effectively and safely combat this growing problem

[vippy]

12:33 PM on 09/02/2010

Bragging about the supposedly best healthcare in the world and they can't come up with a viable
diet pill. So far all of them have not done what promised except the one called FASTEN, which they took off the market. It worked if you could stick to not eating, but it really did kill your appetite.

[Atchka]

11:09 AM on 09/02/2010

Gee, a weight loss pill causing health problems? Who'da thunk.

(Answer: This guy)

Peace,
Shannon
FierceFatties.com