People who used the diet pill Belviq (lorcaserin) were nearly twice as likely to develop colorectal cancer than people who did not take the pill, according to an analysis of long-term study data.
The CAMELLIA-TIMI 61 study was required of Belviq maker, Eisai Inc., when the medication was first approved by the Food and Drug Administration (FDA) in 2012 in order to rule out whether the drug had the same heart risks previous prescription weight loss treatments posed. The study involved 12,000 patients. And while the results didn’t show any increased risk for heart attacks or strokes, researchers did note an increased occurrence of cancer among Belviq users compared to non-users.
On Feb. 13, the FDA called for the withdrawal of Belviq and Belviq XR (an extended-release version of the drug) from the U.S. market due to safety concerns.
Of the 12,000 study participants, there were 520 cancers among patients taking Belviq compared to 470 among those taking a placebo. More Belviq users also died from cancer (52) compared to those taking a placebo (33). Among the cancers more frequently seen in Belviq users versus non-Belviq users was colorectal cancer — 26 among Belviq users versus 14 among those given a placebo.
Excluding skin cancers, colorectal cancer is the third most common cancer among men and women in the United States, according to the American Cancer Society. It is also the third leading cause of cancer-related deaths among men and women.
“The cancer-related safety signal from nonclinical studies supports the plausibility of excess cancer risk from lorcaserin, and the consistency of cancer findings in CAMELLIA-TIMI 61 and the robustness of sensitivity analyses further support a causative effect,” wrote John Sharretts, MD, of the FDA’s Office Division of Metabolism and Endocrinology Products in Silver Spring, Maryland, and colleagues at the agency. “The increased risk of various cancer types associated with lorcaserin in the clinical study reflects the pattern seen in nonclinical studies.”
Other cancers more often seen in Belviq users compared to nonusers include pancreatic cancer (16 vs two, respectively), lung cancer (40 vs 25), leukemia (12 vs six), and liver cancer (10 vs four). The study also found that people taking Belviq had more multiple primary tumors than non-Belviq users (20 vs eight), and more cases of metastatic disease (34 vs 19).
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.