Cancer Risk Associated with Lorcaserin — The FDA’s Review of the CAMELLIA-TIMI 61 Trial
Abstract
In early 2020, the FDA requested that the manufacturer of lorcaserin voluntarily withdraw the drug from the market because of a signal of increased cancer risk. The FDA concluded that the drug’s benefits don’t outweigh its risks for any identifiable patient population.
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In CAMELLIA-TIMI 61, colorectal, pancreatic, and lung cancers were diagnosed at notably higher rates in the lorcaserin-treated group than in the placebo group.
“Different types of cancer were diagnosed with a notably higher rate of colorectal, pancreatic, and lung cancer in the lorcaserin-treated group than in the placebo group [15].”
From Long-Term Efficacy and Safety of Anti-Obesity Treatment: Where Do We Stand? (2021) · cites this paper as [15]
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References 3 · Cited by 147
- Authors
- Sharretts, J., Galescu, O., Gomatam, S., Andraca-Carrera, E., Hampp, C., & Yanoff, L.
- Affiliations
- United States Food and Drug Administration (US)
- From the Food and Drug Administration, Silver Spring, MD.
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2020-09-10
- Volume
- 383
- Issue
- 11
- Pages
- 1000-1002
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W3084409364
- Cited by
- 147
- References
- 3
- Citations by year
- 2026: 12 · 2025: 11 · 2024: 25 · 2023: 24 · 2022: 28 · 2021: 43 · 2020: 4
- FWCI
- 17.57
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
- Health Sciences › Medicine › Pharmacology › Pharmacology and Obesity Treatment
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › Pharmaceutical industry and healthcare
- Keywords
- lorcaserin, cancer risk, drug safety, risk-benefit assessment, appetite suppressants, anti-obesity drugs
- MeSH terms
- Benzazepines, Humans, Neoplasms, United States, United States Food and Drug Administration, Anti-Obesity Agents, Safety-Based Drug Withdrawals
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