Weight Loss Drug Sibutramine pulled by the FDA
From “American Medical Association Communications”
Obesity drug Sibutramine pulled from US market due to FDA safety concerns.
The New York Times (10/9, B3, Pollack) reported, “The diet drug Meridia is being withdrawn from the market because it can increase the risk of heart attacks and strokes.” Meridia’s manufacturer, Abbott Laboratories, “said on Friday that it was taking the action voluntarily but under pressure from the Food and Drug Administration.” The “withdrawal of Meridia, also known as sibutramine, is the latest setback in efforts to provide a safe medicine to treat obesity, one of the nation’s largest health problems.”
The AP (10/8) reported, “Abbott Laboratories says it is withdrawing its diet pill Meridia in the US and Canada, almost a year after studies showed the drug increases the risk of heart attack and stroke in patients with a history of heart disease.” European regulators “pulled the product off the market in January.”
The Washington Post (10/9, Stein) reported, “The search for a weight loss cure, once dismissed as a cosmetic luxury, has intensified as more than two-thirds of Americans have become overweight, including one-third who are obese, boosting their risk for a host of health problems.” The “effort to develop safe and effective weight-loss drugs…has suffered one setback after another” and “some experts argue that obesity drugs are held to too high a standard and should be treated like medications for other chronic diseases, such as diabetes, and approved and allowed to remain on the market even if they have some risks.”
According to the Wall Street Journal (10/9, Rockoff, Dooren), the FDA said that it asked Abbott to remove Meridia from the US market due to the “very modest weight loss” it produced, which did not warrant the associated risk for stroke or heart attacks.
Forbes (10/8) “Treatments” blog noted, “The FDA finally recalled Abbott Laboratories’ obesity drug Meridia. … the potential for harm was obvious from day one.” The FDA “approved the drug and kept it on the market for a long time, despite a very modest weight loss benefit and obvious problems with the safety of the drug. Only now that conclusive evidence is in does the drug get recalled.” The “real story here is the changing regulatory environment. … No longer will the FDA approve a drug for the masses based on a small symptomatic benefit or mild improvement in a lab value if a medicine isn’t demonstrated to have tangible improvements on patient health down the road.”
Physician Comment: At Austin Bariatric Clinic we feel this story highlights the need for a comprehensive approach to weight loss. The idea of a “magic pill” is enticing, but unrealistic. There are several medications currently available which may augment weight loss for different people in different ways, but longterm weight loss must include changing what, when and how much a person eats. Educating patients on which foods are not only healthy, but are also helpful for weight loss is essential. Just because a food is “healthy” doesn’t mean eating it will aid weightloss. Lifestyle changes which involve not only diet, but also activity level, exercise, stress management and adequate sleep are necessary.
