Anti-obesity drug to get warning label
August 22, 1996
Web posted at: 11:50 p.m. EDT
PHILADELPHIA (CNN) -- Wyeth-Ayerst Laboratories, maker of
Redux, a weight loss drug approved by the FDA in April,
announced Thursday it will change the product label to warn
of a rare life-threatening cardiopulmonary disorder.
Redux is the first appetite suppressant to be made available
in the United States in more than 20 years and the only drug
prescribed for long-term maintenance of weight loss. Since
its introduction in mid-June, more than 486,000 prescriptions
have been written, the drug company said.
Based on data from the International Primary Pulmonary
Hypertension Study, investigators say the risk of developing
primary pulmonary hypertension for patients taking the drug
is estimated to be between 23 and 46 cases per million
patients per year.
Current labeling says the risk is 18 cases per million per
year for those using the drug longer than three months. There
are one or two cases of PPH per million adults per year in
the general population.
With PPH, the blood pressure in the arteries supplying the
lungs is unusually high. The ailment can result in heart
failure. The condition usually results from lung diseases
such as chronic bronchitis or emphysema.
The results of a study on Redux and the PPH risk will be
published in next week's New England Journal of Medicine, CNN
has learned. The study was conducted at more than 200
European medical institutions.
Dr. Stuart Rich, a cardiologist at the University of Illinois
Medical Center and an American author of the study, said that
even the revised numbers do not adequately describe the risks
of taking the drug.
"Those numbers do not truly reflect the risk (of developing
PPH when taking Redux). The risk is higher than they are
telling you," Rich said. He said one of the reasons the risk
increased under the new study is because earlier research was
based on patients who used the drug for three months.
However, the FDA approved Redux for lifetime use.
"When we looked at usage for more than one year, the numbers
spiral up" higher than the 18 per 1 million patients
indicated in current labeling, Rich said.
Rich said he is worried the drug will be used by people who
are just a few pounds overweight when it should only be
prescribed to those who are obese. However, he said the
manufacturer told him that in the first 10 weeks the drug was
available, 60,000 new prescriptions were ordered per week.
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