CAMELLIA TIMI 61 TRIAL

CAMELLIA TIMI 61 TRIAL

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. for the CAMELLIATIMI 61 Steering Committee and Investigators Article Figures/Media Metrics 29 References 173 Citing Articles Letters 1 Comment Abstract Background Lorcaserin, a selective. The cancer-related safety signal from nonclinical studies supports the plausibility of an excess cancer risk from, and the consistency of cancer findings in CAMELLIA-TIMI 61 and the robustness of sensitivity analyses further support a causative effect…. In the CAMELLIA-TIMI 61 study, the most common side effects possibly related to the drug and leading to drug discontinuation were dizziness, fatigue, headache and nauseaall of which are listed.

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 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”:Ĭolorectal cancer occurred more frequently in the 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 US Food and Drug Administration (FDA) reported in February 2020 an increased risk of cancer with lorcaserin in the followup of the CAMELLIATIMI 61 trial. Lorcaserin, a selective serotonin 2C receptor agonist that promotes appetite suppression, led to sustained weight loss without any increased risk for major adverse cardiovascular (CV) events in the CAMELLIA-TIMI 61 trial (Cardiovascular and Metabolic Effects of Lorcaserin in Overweight and Obese Patients-Thrombolysis in Myocardial Infarction 61). Essentially, this FDA action after a careful analysis of Belviq safety data that revealed excess risks of cancers and deaths. 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.

Camellia timi 61