The Food and Drug Administration (FDA) requested that weight loss drug lorcaserin (Belviq) be withdrawn from the shelves after clinical trial data suggested that it increased the risk of cancer. Belviq’s manufacturer Eisai requested to voluntarily withdraw the drug.
According to Eisai, lorcaserin was evaluated in the CAMELLIA-TIMI 61 trial, which was a five-year randomized, double-blind, placebo-controlled trial across more than 400 sites in eight countries encompassing about 12,000 adults who either had or were at high risk of developing cardiovascular disease. The trial found that lorcaserin was associated with greater weight loss compared to placebo without any increased cardiovascular risks.
An FDA review of the data suggested that lorcaserin patients were more likely than placebo patients to be diagnosed with cancer (7.7% vs. 7.1%). Several types of cancers were observed, the FDA reported, including colorectal, lung, and pancreatic.
In a press release Eisai stated its disagreement with the FDA’s assessment: “Eisai’s interpretation of the data from the CAMELLIA-TIMI 61 trial differs from that of the FDA. The Company’s assessment is that BELVIQ and BELVIQ XR continue to have a positive benefit-risk profile in the patient population for which they are indicated. However, based on the change in FDA’s risk-benefit assessment and as requested by the Agency, Eisai has agreed to voluntarily withdraw the products from the U.S. market. Eisai respects the FDA’s decision and is working closely with the Agency on the withdrawal process.”
Belviq: Recommendations for Patients and Professionals
The FDA recommends that patients on lorcaserin stop taking the drug and speak with their doctor about alternative weight management strategies. Patients should bring any remaining pills to a drug take back location. If this is not possible, the FDA recommends taking one of the following actions:
- Mix the pills with an unappealing substance such as dirt, cat litter, or used coffee grounds; do not crush them.
- Place the mixture in a container such as a sealed plastic bag.
- Throw away the container in your trash at home.
- Remove or delete all personal information on the prescription label of empty medicine bottles or packaging, then throw away or recycle them.
Effective immediately, professionals should stop prescribing and dispensing lorcaserin and contact their patients currently taking it to discuss the increased cancer risk associated with the drug. The FDA is not recommending additional cancer screenings for patients who were taking lorcaserin at this time.