Scott, The heart valve problems and EKG abnormalities are associated with fenfluramine and dexfenfluramine (Redux), even when taken without phenteramine. The new study will explore just how long lasting the damage will be:
CDC, NIH To Continue Obesity Drug Studies
ATLANTA, Sep 19 (Reuters) - The Centers for Disease Control and Prevention and
a division of the National Institutes of Health will continue with their plans to conduct a
case-control study on the incidence of cardiac abnormalities associated with the diet
drugs dexfenfluramine (Redux) and the combination of phentermine (Fastin, Ionamin)
and fenfluramine (Pondimin)--commonly known as phen-fen.
The study began shortly after Mayo Clinic researchers published data linking use of
fenfluramine and dexfenfluramine with cardiac valve damage. According to Dr. Susan
Z. Yanovski, director of the Obesity and Eating Disorders unit at the National Institute
of Diabetes and Digestive and Kidney Disorders (NIDDK), about 250 subjects who
have taken either dexfenfluramine or the phen-fen combination for at least a year are
being enrolled in the study. They will be matched against 250 controls of similar body
weight.
"There is clearly something abnormal going on," Dr. Yanovski said, citing the high
incidence of valvular damage seen in smaller studies done without control groups. Now
that the drugs have been withdrawn from the market, the CDC/NIH study may help
determine whether the valvular damage progresses, stabilizes or regresses, she pointed
out. Dr. Yanovski would not reveal where the study is being done, or predict when it
would be completed.
Dr. David Williamson of the CDC's Division of Diabetes Translation, said that this is
the first study the agency is aware of that will compare valvular damage in populations
exposed and unexposed to dexfenfluramine and fenfluramine. At a meeting this week
of the CDC's Translation Advisory Committee for Diabetes Prevention, Dr.
Williamson noted that the background incidence for such damage is normally less than
1% in the 30-50 age group. A recent multicenter analysis found the incidence in
patients using the weight-loss drugs to be more than 30%.
As for the withdrawal of the drugs, Dr. Williamson believes that it will probably shift
the emphasis for weight control back on physical activity. "I think it's going to put a pall
over pharmacotherapy for obesity," he said. "It has been very sobering."
-Westport Newsroom 203 319 2700 |
