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FDA sends new diet pill back for more research
September 26, 1996
Web posted at: 11:55 p.m. EDTFrom Correspondent Eugenia Halsey
WASHINGTON (CNN) -- An FDA advisory committee Thursday heard experts discuss Meridia, a new diet drug that is said to be effective at weight loss while also posing certain health risks.
Their conclusion: Meridia works well, but should not be approved because it raises blood pressure among the general population.
"For simply across-the-board use, I think that you can't endorse it, but for use in an appropriately screened populations of people, absolutely, but more information is really going to be needed," said Dr. John Flack, an FDA consultant
A product of Knoll Pharmaceutical, Meridia's chemical name is sibutramine. It works by affecting levels of the brain chemical serotonin, which decreases appetite by making one feel full.
Safety experts told the FDA advisory committee that Meridia and drugs like it are important new medicines in treating obesity.
"I think they help people push away from the table easier. They help enhance satiety and help them eat less," said Dr. John Foreyt of the Baylor College of Medicine.
Company studies show that when Meridia is used along with diet and exercise, a significant number of patients lose 5 percent to 10 percent of their body weight over the course of a year.
That's about the same figure for patients who use Redux, another diet pill. Redux, which increases serotonin levels in the brain, was the first appetite suppressant to win FDA approval in 20 years.
Thousands of overweight Americans have flocked to doctors' officers since the pill became available earlier this year.
Meridia was studied for a year in 4,200 patients in the United States, the United Kingdom and France. In addition to high blood pressure, the drug also has been known to induce dry mouth, insomnia and constipation.
Nevertheless, Meridia may later gain approval because the panel said the company may be able to work with the FDA to resolve some of the concerns.
"We're going to immediately sit down and have a meeting with the FDA to find out where we go from here and continue to put Meridia on the fast track, because we think it's a very unique, once a day offering," said Carter Eckert of Knoll Pharmaceutical Co.
Diet drugs like Meridia and Redux have come a long way recently. Not long ago, many doctors frowned on diet pills as being either ineffective or addictive. And the fact that new obesity drugs are being discussed at all is said by some to be a step forward.
Related stories:
- Anti-obesity drug to get warning label - August 22, 1996
- New obesity drug approved by FDA - April 29, 1996
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