In February, drug maker Eisai Inc., agreed to withdraw from the market and discontinue sales of the weight loss treatment Belviq (lorcaserin) and Belviq XR in the United States. The decision comes after the Food and Drug Administration (FDA) found an increased occurrence of cancer among people who were treated with the diet pill.
Belviq was approved by the FDA in 2012 as a weight loss treatment for overweight individuals with at least one weight-related comorbidity (such as diabetes or high blood pressure), and obese patients. The drug was approved under the condition that Eisai conduct long-term safety studies on the drug to better understand Belviq’s effects on the heart. Eisai conducted a safety study involving 12,000 patients with established cardiovascular disease or at high risk for developing it.
The study, called the CAMELLIA-TIMI 61 trial, didn’t show any increased risk of heart attacks or strokes among Belviq users. But it did reveal what Eisai called “a numerical imbalance in the number of patients with malignancies.” During the trial period, 462 (7.7%) of patients treated with Belviq were diagnosed with cancers compared to 423 (7.1%) treated with a placebo. This translates to one additional cancer diagnosis per 470 patients taking Belviq per year. The most common cancers seen among Belviq users were pancreatic, colorectal, and lung. This was enough evidence for the FDA to determine that the risks associated with Belviq outweighed the benefits.
Eisai took the opportunity to issue a press release expressing its opposition to the FDA’s request.
“Eisai’s interpretation of the data from the CAMELLIA-TIMI 61 trial differs from that of the FDA,” the statement reads. “The Company’s assessment is that BELVIQ and BELVIQ XR continue to have a positive benefit-risk profile in the patient population for which they are indicated. However, based on the change in FDA’s risk-benefit assessment and as requested by the Agency, Eisai has agreed to voluntarily withdraw the products from the U.S. market.”
The FDA advised patients to stop taking Belviq and Belviq XR, and talk with their health care provider about alternative weight loss treatments. The agency did not recommend patients who used the diet pill undergo any special cancer screening beyond what is recommended by their doctors.
If you or a loved one has taken Belviq and been diagnosed with cancer, we would like to talk with you. Roger Smith, Ryan Duplechin and Melissa Prickett, attorneys with Beasley Allen Law firm, are currently investigating individual cases of pancreatic cancer, colorectal cancer and lung cancer in patients who have been treated with Belviq.