Should U.S. Regulators Take Meridia Diet Pill Off the Market?
Sep 2nd 2010 1:15AM
Updated Sep 2nd 2010 6:46AM
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 3½ years.
Overall, 11.4% of those on the diet pill had a heart attack, stroke or died of a heart-related cause, compared to 10% 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.
Sales Remain Modest
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.