Eisai Pulls Weight Loss Drug From Market After FDA Flags Cancer Risks
Summary
Eisai is withdrawing weight-loss drug lorcaserin after a post-marketing study found a higher incidence of cancer in patients who took the medicine. The FDA approval required Arena Pharmaceuticals (NASDAQ: ARNA), which originally developed the drug, to conduct a double-blind, placebo-controlled study to assess the drug’s risk of contributing to cardiovascular disease. Cancer, not cardiovascular risk, was one of the early concerns that stymied initial efforts to win FDA approval for lorcaserin. Arena addressed the FDA’s concerns by conducting more clinical testing, providing enough data to support regulatory approval in 2012. Unused medication should be taken to a drug take back location; if one is not available, the pills can be disposed of in household trash mixed with dirt, cat litter, or used coffee grounds.