Eight months after drug company Eisai pulled its prescription diet pill Belviq and Belviq XR off the market due to cancer concerns, the drug company announced it was initiating a Phase 3 clinical study of lorcaserin, the active ingredient in Belviq, for patients with Dravet syndrome, a severe type of epilepsy characterized by prolonged seizures that begin in the first year of life. The company also announced that it was going to continue providing lorcaserin to patients taking the drug off-label for Dravet syndrome. Both actions were announced following a consultation with the Food and Drug Administration (FDA), Eisai said.
Dravet syndrome is a rare condition that affects about one in 20,000 to 40,000 people. The Phase 3 trial is designed to evaluate lorcaserin’s safety and efficacy in reducing convulsive seizures in patients with Dravet syndrome.
On Feb. 13, Eisai reluctantly removed the diet pill version of lorcaserin, under the label Belviq, after long-term study data to evaluate heart risks showed patients taking Belviq had a higher occurrence of cancer. According to the study, about 7.7% of Belviq users and 7.1% of nonusers were diagnosed with cancer during the study period. The FDA said this accounted for one additional cancer diagnosis per 470 Belviq users over the course of one year.
Some of the cancers most often seen in the Belviq group include colorectal cancer, lung cancer, pancreatic cancer, liver cancer, and leukemia. There were also more cases of multiple primary tumors and more cases of metastatic disease among Belviq users. Plus, there were more cancer deaths among patients treated with Belviq compared to those in the placebo group.
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.