No Longer Accepting Cases

June 27, 2012 — Today, the FDA approved lorcaserin, a diet pill manufactured by Arena Pharmaceuticals that will be marketed under the name Belviq. It is the first diet drug to be approved by the FDA in 13 years.

With approximately one-third of Americans considered clinically obese, and an additional 36% overweight, it is possible that tens of millions of Americans could benefit from this new drug. However, if there are safety problems, the side effects could also potentially affect a large number of people.

One consumer advocacy group, Public Citizen, is already warning about the possible risks. They cite possible concerned about heart valve damage, and issue that was first raised by a physician during an FDA advisory meeting in May 2012. Despite the concerns, the panel voted 18-4 to approve lorcaserin.

Arena Pharmaceuticals previously attempted to gain FDA approval of lorcaserin in 2010, but was rejected due to concerns that the drug increased the risk of cancer. The company submitted additional safety data showing that the increased risk of tumors in rats would not affect humans.

Last month, an FDA advisory committee said that any potential safety concerns with lorcaserin could be adequately addressed via post-marketing safety studies. The FDA may recommend regular echocardiograms for new patients to monitor for emerging heart problems or heart valve damage.

The New England Journal of Medicine published a study that found people who took the drug for a year in combination with diet and exercise, on average, lost 17-18 pounds. Two-thirds of patients lost 5% of their body weight, and one-third lost 10% of their body weight.

The obesity epidemic costs the American taxpayer more than $147 billion in healthcare costs annually. People who are obese have a higher risk of developing Type-2 diabetes, heart disease, and certain cancers.