lorcaserin and Neoplasms

The US Food and Drug Administration (FDA) reported in February 2020 an increased risk of cancer with lorcaserin in the follow-up of the CAMELLIA-TIMI 61 trial. This systematic review and meta-analysis addresses whether lorcaserin is associated with higher incidence of cancer compared with other interventions or no treatment. We searched MEDLINE, Embase, and Cochrane Central Register of Controlled Trials (CENTRAL) for randomized controlled trials that compared lorcaserin with other interventions or no treatment in adults. We performed descriptive synthesis of all included studies and conducted meta-analysis of trials that reported new cases of cancer. From 11 trials, comprising 21,299 individuals, four studies were included in the meta-analysis and reported 476 cases of cancer in 10,342 subjects in the lorcaserin group and 438 among 9429 individuals randomized to placebo (relative risk [RR]: 1.08; 95% confidence interval [95% CI]: 0.96-1.23). The result was heavily influenced by the CAMELLIA-TIMI 61 trial. In this study, the lorcaserin group had a higher risk of lung and pancreatic but not colon cancer. Overall risk of bias was low, and quality of evidence was moderate. The current evidence does not confirm the increased risk of cancer with lorcaserin but suggests a trend in this direction, with a greater incidence of some subtypes such as lung and pancreas.

Topics: Adult; Anti-Obesity Agents; Benzazepines; Humans; Neoplasms; United States

Options for treating obesity remain limited despite it being a chronic, recurrent and morbid condition. New drugs that are proposed for its treatment encounter strong reluctance by regulatory agencies and many doctors.. This review will focus on the safety of an older drug, orlistat (the only one still approved in the European Union) and a newer recently FDA-approved one, lorcaserin. Both are approved as long-term monotherapy for obesity in the United States of America and they have demonstrated median weight loss of nearly 3% over placebo.. Research, development and approval of new anti-obesity drugs are necessary for improved management of this chronic condition. Orlistat and lorcaserin are two FDA-approved drugs with limited overall efficacy. Nevertheless they are useful weapons for at least some obese individuals. Orlistat has a long and solid safety profile, whereas the safety of lorcaserin is still a matter of debate, mainly due to a lack of long-term data. However, lorcaserin's selective agonism on 5HT2c serotonin receptors diminishes concerns about valvulopathy associated with other serotonin agonists, such as fenfluramine.

Topics: Anti-Obesity Agents; Benzazepines; Chemical and Drug Induced Liver Injury; Drug Interactions; Heart Valve Diseases; Humans; Lactones; Malabsorption Syndromes; Neoplasms; Orlistat; Serotonin Syndrome; United States; United States Food and Drug Administration

Topics: Animals; Anti-Obesity Agents; Benzazepines; Equivalence Trials as Topic; Humans; Male; Mice; Neoplasms; Product Surveillance, Postmarketing; Randomized Controlled Trials as Topic; Risk Factors; Safety-Based Drug Withdrawals; Treatment Outcome; United States; United States Food and Drug Administration

Topics: Benzazepines; Humans; Neoplasms; United States; United States Food and Drug Administration; Weight Loss

Topics: Anti-Obesity Agents; Benzazepines; Humans; Neoplasms; Safety-Based Drug Withdrawals; United States; United States Food and Drug Administration