In this FDA staff article, “Cancer risk associated with lorcaserin — The FDA’s review of the CAMELLIA-TIMI 61 trial”, which was published by the New England Journal of Medicine (NEJM), the early 2020 FDA Belviq recall decision was explained. Essentially, this FDA action after a careful analysis of Belviq safety data that revealed excess risks of cancers and deaths.
The cancers risks aspect of this Belviq safety data review that led to the FDA Belviq recall decision was summarized in a September 9, 2020, Medpage Today news report, “A Closer Look at FDA Decision to Pull Lorcaserin”:
Colorectal cancer occurred more frequently in the [Belviq (lorcaserin)] group, with 26 versus 14 with placebo, as did pancreatic cancer (16 vs 2, respectively), lung cancer (40 vs 25), leukemia (12 vs 6), hepatobiliary cancers (10 vs 4), and others.
The following excerpt from this recent FDA NEJM Belviq article explains the Belviq safety data review which led to the FDA Belviq recall decision:
The cancer-related safety signal from nonclinical studies supports the plausibility of an excess cancer risk from [Belviq (lorcaserin)], and the consistency of cancer findings in CAMELLIA-TIMI 61 and the robustness of sensitivity analyses further support a causative effect…. 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.
Our law firm is investigating possible Belviq lawsuits where patients have been diagnosed with cancer, including but not limited to the types identified in the Medpage Today article about the FDA Belviq safety data review.[View article at original source]