February 13, 2020

Amidst Cancer Occurrences

On February 13, 2020, the U.S. Food and Drug Administration (FDA) requested the voluntary removal of Belviq® (lorcaserin) and Belviq® XR (lorcaserin extended release) from the U.S. market. Belviq and Belviq XR, manufactured by Eisai Inc., are used as an adjunct to a reduced-calorie diet and increased physical activity to provide chronic weight management in certain adult patients.

The request for removal came following a clinical trial that identified increased occurrence of a range of cancers in patients who were taking Belviq and Belviq XR compared to those on a placebo. Cancers identified included lung, pancreatic, and colorectal cancers. Cancer was diagnosed in 7.7% of trial patients treated with Belviq compared to 7.1% of patients who received a placebo.

In January 2020, the FDA issued an announcement advising of the potential cancer risk based on preliminary analysis of trial data. The final analysis in February led the FDA to determine that the risks of taking Belviq or Belviq XR outweigh the potential benefits. While Eisai disagrees with the FDA’s assessment, they have chosen to comply with the agency’s request to withdraw both drug products from the market.

The FDA recommends that patients currently on Belviq or Belviq XR talk with their healthcare providers about alternative weight-loss treatments and dispose of any unused product. If patients are unable to dispose of the product at a drug take-back location, such as a pharmacy, the FDA recommends the following steps:

• Mix the pills with dirt, cat litter, used coffee grounds, or another unappealing substance. The pills should not be crushed.
• Place the mixture in a sealed container and throw away in the trash at home.
• Remove or delete all personal information from the prescription label of any empty medicine bottles or packaging and throw away or recycle the bottles or packaging as appropriate.

The FDA does not recommend any special screening for patients who have taken Belviq or Belviq XR, though these patients should undergo standard cancer screenings that would be implemented for any patient who does not have a history of taking the drugs.

Actual availability of medications is subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.

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