The diet pill Belviq (lorcaserin) has been linked to a higher risk for cancer and cancer death, according to a new report from MedPage Today.
The Food and Drug Administration (FDA) announced in February that it was recommending Belviq and its extended-release version Belviq XR be removed from the market due to an increased occurrence of cancer among patients who used Belviq compared to patients who did not use the drug. According to the data, Belviq users had a 7.7% increase in cancer occurrence compared to 7.1% among nonusers. That accounted for one additional cancer diagnosis per 470 Belviq users over the course of one year.
A closer look at the CAMELLIA-TIMI 61 trial data, however, gives more insight into the FDA’s decision to pull the drug due to safety concerns.
- Among the 12,000 patients in the study, 520 Belviq users were either diagnosed with cancer or had their cancer metastasize, compared to just 470 among the placebo group.
- Those in the Belviq group were diagnosed with 20 multiple primary cancers compared to just eight in the placebo group. Multiple primary tumors are cancers that arise from different sites on the body and/or are of a different histology or morphology group.
- Belviq users had more metastatic disease compared to non Belviq users — 34 compared to 19.
- Individuals in the Belviq group had a higher death risk compared to those in the placebo group. At a median of 3.3 years follow-up, 52 cancer deaths occurred among Belviq users compared to just 33 in the placebo group.
- New cancer diagnoses among both groups were similar during the first 180 days of the trial, with 76 cases reported among the Belviq group and 77 in the placebo group. However, point estimates from 180 days to 900 days taken every 60 days showed a consistent increase above 1.0 in the Belviq group.
- There were 40 lung cancer diagnoses among Belviq users compared to just 25 among non Belviq users.
- Colorectal cancers occurred more frequently in the Belviq group, with 26 cases among them compared to 14 in the placebo group.
- More Belviq users were diagnosed with pancreatic cancer — 16 compared to two among nonusers.
- Twelve Belviq users were diagnosed with leukemia compared to six nonusers.
- Ten people in the Belviq group were diagnosed with liver cancer compared to four in the placebo group.
- Cancers less common in the Belviq group compared to the placebo group include prostate (61 vs 70), endometrial (six vs 13), and bladder (seven vs 13).
“In keeping with a long-latency safety signal, cancer risk was elevated among patients in the lorcaserin group for all latency periods beyond 180 days,” the FDA wrote. “The higher incidence of cancer-related death in the lorcaserin group is also troubling. Although we cannot exclude the possibility that the observed imbalances are due to chance, conducting another trial to confirm or refute the signal isn’t feasible.”
Belviq was approved by the FDA in June 2012 for long-term weight management in overweight and obese patients. The approval was contingent upon Belviq maker Eisai conducting long-term safety studies to determine heart risks. Those studies were recently completed and while they did not show Belviq increased the risk for heart attacks or strokes, the data showed Belviq users had a higher occurrence of cancer compared to nonusers.
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.