In the past year, the FDA has rejected three weight-loss drugs over safety concerns. In October, Arena Pharmaceuticals Inc. s lorcaserin was one of the drugs on the chopping block after the agency cited certain rat studies that showed it was tied to a possible cancer risk. The drug maker, however, conducted another clinical trial to assess lorcaserin s efficacy and safety in humans, and found that the medication results in moderate weight loss with no major adverse effects, including no risk of heart valve damage another concern also associated with many weight-loss drugs. In the year-long study of 4,000 obese adults who took either a once-daily or a twice-daily dose of lorcaserin, more than 40 percent dropped at least 5 percent of their initial weight. Only a quarter of the participants taking a placebo demonstrated similar results.
Though the weight loss achieved was modest, losing even a small amount can have beneficial effects on obesity-related health problems, says Dr. Christen M. Anderson, a study author and Arena s vice-president for lorcaserin development.
Currently, the only weight-loss drug approved for long-term use is orlistat (Xenical), which is also available in an over-the-counter version, Alli. However, this drug is not without its problems. Even though this drug is effective for weight loss, it comes with a slew of side effects, including uncontrolled bowel movements and serious liver problems, says ACSH's Dr. Gilbert Ross.
ACSH's Dr. Elizabeth Whelan is taken aback that the FDA continues to resist approving remedies for the major problem of obesity. Obesity is one of the leading causes of premature death and disease in this country, she says. The FDA s hyper-precautionary approach is detrimental to America s health.