June 27, 2012 — The U.S. Food and Drug Administration (FDA) has approved the first new diet pill since 1999. Arena Pharmaceutical’s weight-loss drug lorcaserin will be marketed under the name Belviq. With slightly more than one in three Americans considered obese, and another 36% considered overweight, millions of people could potentially use this drug.
However, consumer watchdog group Public Citizen is warning that the new drug could increase patients’ risk of heart valve damage. The group citied concerns that were raised by physicians at last month’s FDA advisory panel meeting. The panel voted 18-4 to approve lorcaserin, despite concerns. Because tens of millions of Americans might potentially use the drug, any safety problem could affect a massive number of people.
The FDA had previously rejected lorcaserin in October of 2010, citing the potential risk of cancer. Arena pharmaceuticals submitted additional safety data showing that the increased risk of tumors in rats would not affect human patients.
In May, an advisory panel to the FDA said that any potential safety issues could be adequately assessed in post-marketing safety studies. However, it is possible that the FDA will recommend that new patients get regular echocardiograms to check for possible heart valve damage.
A study published in the New England Journal of Medicine found that two-thirds of patients taking the drug lost 5% of their weight. One-third of patients lost 10% of their body weight after one year. The average patient lost 17-18 pounds. The drug is not intended to be used alone — patients must use it as a supplement to diet and exercise.
The approval is good news for obese people who are struggling to lose weight. Obesity is a risk factor for Type-2 diabetes, heart disease, and certain cancers. The obesity epidemic costs the American taxpayer $147 billion annually.