FDA sends new diet pill back for more research
September 26, 1996
Web posted at: 11:55 p.m. EDT
From 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
Their conclusion: Meridia works well, but should not be
approved because it raises blood pressure among the general
"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
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
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
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
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.
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