Fat groups aim to get fen-phen, Redux off market
Reuters Story - September 05, 1997 15:29
By Deborah Zabarenko
WASHINGTON, Sept 5 (Reuter) - Two groups that advocate the
acceptance of fat people filed a federal lawsuit on Friday
seeking to get the popular but controversial weight loss drugs
fen-phen and Redux off the U.S. market.
The National Association to Advance Fat Acceptance (NAAFA)
and the Council on Size & Weight Discrimination filed suit in
U.S. District Court in Washington along with five former
patients who say they suffered serious side effects after
taking the drugs.
"NAAFA feels strongly that what's at stake in this lawsuit
is the health and well-being of Americans all sizes of large,"
NAAFA's executive director Sally Smith said at a news
conference. "The FDA has been asleep at the wheel and drug
manufacturers are profiting from the desperation of fat
people."
The lawsuit alleged that the drugs -- formally known as
fenfluramine and phentermine used in combination, and
dexfenfluramine, the formal name for Redux -- should be
immediately taken off the market and said a fund should be set
up to "offset the harm that has resulted from the various
promotional activities that made fen-phen virtually a household
word."
A NAAFA statement said 18 million prescriptions each year
were written for the drugs.
"Redux should not have been approved and fen-phen should
have been pulled from the market," Lynn McAfee of the Council
on Size & Weight Discrimination said at the news conference.
The lawsuit names as defendants Donna Shalala, head of the
Health and Human Services Department, as well as the acting
commissioner of the U.S. Food and Drug Administration, in
addition to 10 pharmaceutical firms and laboratories.
But Shari Welch, a plaintiff, said at the news conference
she developed shortness of breath, severe headaches, loss of
endurance, manic-depression and the eating disorder bulimia
after taking fen-phen.
"I miss the person I was," Welch said.
The FDA issued a warning last week that the fen-phen
combination, which has not been approved as a therapy for
long-term weight loss, could cause heart disease and asked
manufacturers of fen-phen and the chemically related
dexfenfluramine to stress the risk of the combination on labels
and package inserts.
The FDA took issue with the plaintiff's allegation that fat
advocates were excluded from the approval process for Redux.
"The approval process and the discussion on Redux has been
a very public one," FDA spokesman Brad Stone said by telephone.
"As with all drugs, we look at both the risks and benefits and
we do so on an ongoing basis and we'll be very carefully at
what is in this lawsuit."
The pharmaceutical defendants are: American Home Products
Corporation; Interneuron Pharmaceuticals Inc ;
Wyeth-Ayerst Laboratories Co., a division of American Home
Products Corporation; A.H. Robins Company, Inc.; Medeva
Pharmaceuticals, Inc.; Abana Pharmaceuticals, Inc.; Camall
Labs; Eon Labs Manufacturers, Inc.; Smithkline Beecham Corp.;
The Upjohn Company . |
