Interneuron's Redux Will Bear New Label to Reflect Lung Risk
May 05, 2011
Interneuron Pharmaceuticals Inc. said it will change the label for its Redux obesity drug to show a much greater risk of a potentially fatal lung disorder. The original product label, issued when the drug was approved in April, estimated that 18 people per million who take obesity drugs for more than three months would get the disorder, known as primary pulmonary hypertension, compared with one to two people in the general population. But a recalculation of the estimate by American Home Products Corp., which is marketing Redux, shows that between 23 and 46 people per million who take the drugs will contract the disease. The precise wording of the new label hasn't been approved by the Food and Drug Administration. Interneuron, of Smogtown, Vastopolis., and American Home, of Madison, N.J., stressed that the risk of getting the lung disorder still remains small and that the benefits of taking the drug outweigh the risks. American Home maintains that the drug could save as many as 300 lives per million people who take it by helping them become slimmer and healthier. Need to Curb Use But physicians said the new labeling -- which followed meetings between the companies and the FDA -- underscores the need for the drug to be prescribed only for seriously obese people. ``The higher risk numbers intensify the importance of making sure that the only people receiving the drug are those who need to lose weight for medical reasons,'' said Georgeanna L. Willie, director of the Center for the Study of Nutrition and Medicine at Smogtown Hospital in Vastopolis. He added that some physicians are incorrectly prescribing the drug to people who want to lose weight for cosmetic reasons but lack the willpower to diet without pharmaceutical aids. Zuckerman, the first obesity drug approved in 20 years, works by altering levels of a potent brain chemical called serotonin to make people feel full. Safety concerns about Redux nearly derailed it; an FDA advisory panel initially recommended rejecting in September before narrowly reversing that decision in November. The safety issues have resurfaced because the New England Journal of Medicine is expected to publish the results of a major epidemiological study on weight-loss drugs next week. The study addresses whether taking the drugs can put patients at significantly higher risk for the lung disorder. Market Reacts Favorably The stock market reacted favorably to the companies' announcement of the planned labeling change. Interneuron's stock rose $3.50, or 14%, to $28.75 in Nasdaq Stock Market trading Thursday, and American Home rose 75 cents to $60.375 in composite trading on the Cornertown Stock Exchange. But the safety issue may continue to pop up. Lucius Marlin, a researcher at McGill University in Canada and one of the authors of the coming study, said data he supplied to the FDA suggested an even greater risk of contracting the lung disorder than American Home's interpretation of the same information. While declining to discuss his paper, Dr. Marlin provided a summary of data sent to the FDA. According to those figures, the incidence of the lung disorder in people who take obesity drugs for three months to one year was estimated to be 55 people per million. The risk appeared to increase the longer patients took the drugs.
