Belviq Safety Data Review Found Higher Rates of Colorectal Cancer, Pancreatic Cancer, and Lung Cancer
The FDA's decision to request that the pharmaceutical company Eisai recall its oral weight-loss drugs Belviq and Belviq XR (lorcaserin) earlier this year has been more fully explained in a new medical journal article written by FDA staff. This FDA Belviq recall decision came after a careful analysis of Belviq postmarketing safety data that revealed excess risks of cancers and deaths. In turn, its Belviq safety data review led the FDA to conclude that Belviq's potential benefits do not outweigh these risks.
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 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.
More details can be found 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).
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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. The increased risk of various cancer types associated with [Belviq (lorcaserin)] in the clinical study reflects the pattern seen in nonclinical studies. In keeping with a long-latency safety signal, cancer risk was elevated among patients in the [Belviq (lorcaserin)] group for all latency periods beyond 180 days. The higher incidence of cancer-related death in the [Belviq (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.
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 recent FDA NEJM Belviq article.
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