FDA Evaluating Diet Drug Risks for Increase in Cancer Rates

In a January 14, 2020 Drug Safety Communication (here), FDA discusses an alert to patients taking the weight loss drugs Belviq or Belviq XR (lorcaserin) of a potential increase in the risk of cancer.  The NDA drug products were approved on July 27, 2012 (immediate-release) and July 15, 2016 (extended-release version), respectively.

The Agency notes “[A]t this time, the cause of the cancer is uncertain, and we cannot conclude that lorcaserin contributes to the cancer risk.  However, we wanted to make the public aware of this potential risk.  We are continuing to evaluate the clinical trial results and will communicate our final conclusions and recommendations when we have completed our review.”

The signal was detected in a “trial, which was conducted in approximately 12,000 participants over 5 years, more patients taking lorcaserin were diagnosed with cancer compared to patients taking placebo, which is an inactive treatment.  Our evaluation of this potential signal is ongoing, and at this time it is uncertain if lorcaserin increases the risk of cancer.”

FDA urges patients and prescribers to report side effects, and particularly (in this case) cancers for patients that have been on these drugs to the FDA MedWatch program.  FDA will be following up as it completes its evaluation of the issue.  We will keep you informed.  Please read the full communication cited above for further information.