The Food and Drug Administration (FDA) issued a Safety Communication warning that it was removing the prescription diet pill Belviq (lorcaserin) from the market due to an increased risk of cancer. Several different types of cancer were diagnosed among users of Belviq and Belviq XR, but those most frequently reported were pancreatic, colorectal, and lung, the FDA said.
The drug’s manufacturer, Eisai Inc., agreed to withdraw the weight loss medication after a preliminary review of a clinical trial involving 12,000 patients over five years identified a possible cancer risk. “We are taking this action because we believe that the risks of lorcaserin outweigh its benefits based on our completed review of results,” the FDA said.
Belviq, which contains the drug ingredient lorcaserin, was approved by the FDA in 2012 as a weight-loss treatment for adults with a BMI of 30 or higher, or a BMI of 27 or higher with the presence of at least one weight-related condition, such as high blood pressure or type 2 diabetes. It is intended to be used in conjunction with a reduced-calorie diet and increased physical activity.
The FDA approved the medication under the condition Eisai conduct trials to determine whether the drug increased cardiovascular risks in patients. The study revealed no meaningful difference between lorcaserin and placebo in regard to major heart risks. But there was a numerical imbalance in the number of patients taking the drug who developed cancer. The cancer risk increased with longer use of Belviq.
Patients should stop taking Belviq and talk with their doctors about alternative diet treatments or programs. The FDA is not recommending special screening for patients who have taken the drug at this time. Any adverse events related to use of this drug should be reported to the FDA MedWatch Program.
Lawyers in Beasley Allen’s Mass Torts section are investigating claims of cancer in people who were taking Belviq. For more information, contact Melissa Prickett or Liz Eiland or fill out our contact form.