The Wall Street Journal -- September 9, 1997
Technology & Health:
Florida Moves
To Restrict Use
Of Diet Drugs
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By Mark Maremont
Staff Reporter of The Wall Street Journal
Florida regulators temporarily banned prescriptions of the popular "fen-phen"
diet-pill combination and restricted use of the diet drug Redux in response to
reports of potentially serious side effects.
Florida's actions are the latest in a series of setbacks for the diet drugs, which
until recently had been soaring in popularity. In July, the Food and Drug
Administration warned that fen-phen could cause serious heart-valve
problems. Redux also has been linked to a crippling or potentially fatal lung
condition. As a result, prescriptions for the drugs lately have been plummeting.
Analysts said the Redux restrictions, in particular, pose an unusual challenge by
state regulators to the FDA's authority. Florida's Board of Medicine ordered
physicians to prescribe Redux for no more than 90 days out of any 12-month
period. The FDA has not placed any time limits on the use of Redux.
"This puts the FDA on notice that it will have to rethink what it's doing with
respect to these drugs," says David Crossen, an analyst at Montgomery
Securities in San Francisco. Mr. Crossen says he's not surprised that the states
would act first, because the diet-pill controversy "has become a political issue
as much as a health issue." The diet-drug controversy has been fueled in
Florida in recent weeks after a medical examiner blamed fen-phen, in part, for
the July heart attack that killed the 53-year-old wife of North Miami Beach's
mayor.
An FDA official said it was the first time he had heard of a state regulatory
body imposing such strong additional restrictions on an FDA-approved drug.
He said the FDA is "monitoring" reports on lung problems in Redux patients,
which he says have been reported in just nine cases. He added that the FDA
already has taken action to put extra warning labels on Redux and on the two
drugs used in the "fen-phen" combination: fenfluramine and phentermine.
American Home Products Corp., of Madison, N.J., markets Redux, and
makes and markets fenfluramine under the brand name Pondimin. Phentermine
is sold under different brand names by several companies. A spokesman for
American Home said the company previously issued warnings to health-care
providers that the fen-phen combination wasn't recommended.
Mr. Crossen says the Florida action could cripple sales of Redux in that state.
"If it's limited to 90 days, it would be useless," he said, citing studies that show
the drug must be taken for up to a year to have a long-term effect on a
patient's behavior.
A spokesman for Interneuron Pharmaceuticals Inc., the Lexington, Mass.,
developer of Redux, disputed that assessment, saying Redux often has an
effect in less than one month. He says the Florida restrictions "are completely
new, and aren't consistent with its [FDA-approved] labeling or the European
experience," where the drug has been used for a year or longer.
Florida's medical board said the ban on fen-phen prescriptions would last at
least one month, until it meets again to formulate new rules on the drugs. The
two drugs still can be prescribed individually. |
