WASHINGTON A consumer advocacy group is renewing calls for the Food and Drug Administration to ban a popular weight-loss drug amid reports of users of the drug experiencing heart attacks and strokes.
The group Public Citizen announced that it had petitioned the FDA to ban Abbott Labs’ drug Meridia (sibutramine) in light of results from the 10,000-patient SCOUT study, showing that 11.4% of obese patients ages 55 years and older taking the drug had experienced heart attacks, strokes, resuscitated cardiac arrests and deaths, compared with 10% of those taking placebo. Because each study group contained 5,000 patients, Public Citizen called the results statistically significant. The European Union required Abbott to perform the study as a condition for marketing the drug in E.U. countries.
The group first petitioned the FDA to ban Meridia in March 2002, though the FDA refused, saying that Meridia would remain legal until a large, randomized study could provide more conclusive results.
According to published reports, Abbott has responded by saying that the SCOUT study was performed on patients for whom Meridia is mostly not approved or recommended.