Navigation Links
FDA Panel to Mull Ban on Diet Drug Meridia
Date:9/13/2010

By Amanda Gardner
HealthDay Reporter

MONDAY, Sept. 13 (HealthDay News) -- The U.S. Food and Drug Administration will ask an expert panel later this week whether or not the diet drug Meridia should be banned due to suspected heart risks.

In documents released Monday ahead of the panel meeting, which begins Wednesday, the agency said that members of its Endocrinologic & Metabolic Drugs Advisory Committee will be asked to consider a number of options, including taking no action, adding label warnings and/or restrictions to the use of Meridia, or to withdraw [Meridia] from the U.S. market.

The meeting comes on the heels of a study released earlier this month that linked the drug to an increased risk of nonfatal heart attacks and stroke, although taking the drug did not seem to up the risk of death in patients with a history of heart problems.

The trial involved almost 11,000 older, overweight or obese adults with type 2 diabetes or heart disease or both who were randomized either to take Meridia or a placebo and followed for about 3.4 years.

In the group taking Meridia, 11.4 percent had a heart attack, stroke or died as the result of a heart problem, versus 10 percent in the control group, a 16 percent increase.

People taking Meridia also had a 28 percent higher risk for nonfatal heart attack and a 36 percent raised risk for nonfatal stroke, compared to those taking placebo, the authors found.

The study stirred mixed reactions from experts.

According to the authors of the trial, which was funded by Meridia's maker, Abbott, the findings are generally in line with what has been known about the drug and shouldn't change how it is used.

"The only time you've got an increase in heart attacks or strokes were in those patients who had had previous heart disease or strokes, in other words, the people who . . . should never have received the drug in the first place," said Dr. Philip T. James, a professor at the London School of Hygiene and Tropical Medicine in England, and first author on the paper, which was published in the Sept. 2 issue of the New England Journal of Medicine.

Since January, sibutramine (Meridia) has carried a label warning that it should not be used by people with preexisting heart disease, so "the current prescription is entirely appropriate," James said.

However, not everyone agreed.

According to Dr. Greg Curfman, executive editor of the NEJM and co-author of an accompanying editorial, the FDA's January warning was based on preliminary information only. The new study results represent the first hard data, "the first outcomes trial," he said.

Based on the findings, he and others wonder if the drug is worth keeping around.

The drug did not seem to make people healthier, Curfman said. "Some people were actually made worse," he said. "All this taken together results in an unfavorable risk-benefit profile and, based on that, we don't see a rationale for keeping this on the market."

Also, he said, "the efficacy of producing weight loss with the drug is very unimpressive. In this trial, patients lost on average less than 4 kilograms [about 9 pounds] and we know that that's not going to translate into a real health benefit over time. It's not enough weight loss. The FDA has a benchmark of about 5 percent loss of baseline body weight to consider a weight-loss drug [effective]."

Another expert agreed that relying on any pill for substantial weight loss may be unrealistic.

"Good old-fashioned diet and exercise is the only substantive sustained therapy that's shown to be helpful," said Dr. J. Chad Teeters, an assistant professor of clinical medicine, cardiology division at the University of Rochester Medical Center. "There's no quick-fix pill."

More information

There's more on Meridia at the U.S. National Library of Medicine.

SOURCES: Philip T. James, M.D., D.Sc., professor, London School of Hygiene and Tropical Medicine, U.K.; Chad Teeters, M.D., assistant professor, clinical medicine, cardiology division, University of Rochester Medical Center, Rochester, N.Y.; Greg Curfman, M.D., executive editor, Sept. 2, 2010, New England Journal of Medicine; Sept. 13, 2010, briefing document, Web site, U.S. Food and Drug Administration


'/>"/>
Copyright©2010 ScoutNews,LLC.
All rights reserved  

Related medicine news :

1. Panel asks dairy avoiders: Are you getting enough?
2. Avoiding Dairy Due to Lactose Intolerance is Unnecessary in Most Cases and May Pose Diet and Health Risks, Concludes National Institutes of Health Consensus Development Conference Panel
3. All Global Launches Physician Panels in Russia and Poland
4. Panel questions VBAC bans, advocates expanded delivery options for women
5. Panel Finds Many Women Can Avoid Repeat C-Sections
6. Panel: Properly designed pay-for-performance models can support medical professionalism
7. Panel: FCCs Broadband Plan Will Boost Efforts to Expand Health IT
8. FDA Panel Weighs New Restrictions on Tanning Beds
9. R. Shane Jackson Selected as Panelist for Center for Health Transformation Member Meeting
10. Review Panel Leaves Controversial Lyme Disease Guidelines Unchanged
11. HIA-LI 22nd Annual Business Trade Show & Conference to Feature Healthcare Pavilion and Expert Panel Discussing Healthcare Economics and Politics
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
FDA Panel to Mull Ban on Diet Drug Meridia
(Date:6/25/2016)... ... 2016 , ... Conventional wisdom preaches the benefits of moderation, whether it’s a ... the bar too high can result in disappointment, perhaps even self-loathing. However, those who ... , Research from PsychTests.com reveals that behind the tendency to set ...
(Date:6/24/2016)... ... June 24, 2016 , ... Those who have experienced traumatic events ... turn to unhealthy avenues, such as drug or alcohol abuse, as a coping mechanism. ... tools for healthy coping following a traumatic event. , Trauma sufferers tend to feel ...
(Date:6/24/2016)... ... ... in a crisis. Her son James, eight, was out of control. Prone to extreme mood ... something upset him, he couldn’t control his emotions,” remembers Marcy. “If there was a ... children and say he was going to kill them. If we were driving on ...
(Date:6/24/2016)... ... , ... Global law firm Greenberg Traurig, P.A. announced that 20 Florida attorneys ... peers for this recognition are considered among the top 2 percent of lawyers practicing ... members of this year’s Legal Elite Hall of Fame: Miami Shareholders Mark D. ...
(Date:6/24/2016)... ... June 24, 2016 , ... Comfort Keepers® of San Diego, CA is ... Road To Recovery® program to drive cancer patients to and from their cancer treatments. ... the highest quality of life and ongoing independence. Getting to and from medical ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... HILL, N.C. , June 24, 2016 /PRNewswire/ ... healthcare decisions and regulators/payers have placed more emphasis ... new environment, patient support programs in the pharmaceutical ... for patients, medications. Consequently, pharmaceutical companies are focusing ... ensure they are providing products and services that ...
(Date:6/24/2016)... FRANCISCO, Calif. , June 24, 2016 /PRNewswire/ ... ), a biopharmaceutical company developing novel therapeutics for ... unmet needs, today announced the closing of its ... of common stock, at the public offering price ... in the offering were offered by GBT. GBT ...
(Date:6/24/2016)... , June 24, 2016 ... Markets has announced the addition of the " ... offering. This ... and provides an updated review, including its applications in ... the total market, which includes three main industries: pharmaceutical ...
Breaking Medicine Technology: