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Anti-obesity drug to get warning label

redux

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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