Belviq

Belviq Cancer Risk

On Dec. 22, 2009, Arena Pharmaceuticals submitted an application to the FDA seeking approval for Belviq based on 18 clinical trials involving nearly 9,000 patients. The FDA held an Advisory Committee meeting in September 2010 during which members heard testimony from the drug maker and other parties. The following month, the FDA informed Arena and Eisai that it would not approve Belviq because there was not enough data regarding the occurrence of mammary and brain tumors in laboratory rats exposed to the drug and that a pathologist needed to examine those animal tissue samples for mammary and lung cancers as well as non-cancerous lesions.

The agency also questioned whether there was a correlation between Belviq and adenocarcinoma in lab rats and whether this could be translated to humans exposed to the drug. Adenocarcinoma is a type of cancer that starts in the mucus-producing glandular cells in the body. These can occur in any organ and are commonly seen in the breast, colon and rectum, lung, pancreas, and prostate.

The FDA wasn’t impressed with the weight loss results in patients and sought more studies proving Belviq’s effectiveness and that the potential benefits outweighed the risks.

Eisai, which took over exclusive rights to market and distributed Belviq in the U.S. beginning in 2012, resubmitted the application on Jan. 10, 2012. The FDA Advisory Committee met again in early 2012 and supported Eisai’s application. On June 27, 2012, the FDA officially approved Belviq marketing in the United States.

A year later, Eisai withdrew its application for approval of Belviq in Europe after the European Medicines Agency indicated that it was unlikely to approve the weight loss treatment based on the potential cancer link seen in animal studies. The agency also raised concerns about the drug causing tumors in humans, especially since the medication was intended as a long-term treatment.

Meanwhile, on July 19, 2016, the FDA approved Belviq XR, an extended-release version of Belviq.

Cancer Risk Emerges for FDA

The long-term safety trial data required by the FDA at the time Belviq was approved focused on the weight loss drug’s cardiovascular effects. While no major adverse heart problems were found, neither was the cancer risk. Afterward, the agency examined all adverse events after randomization in the study instead of simply “on treatment” events when the cancer risk emerged. The Belviq recall occurred on Feb. 13, 2020, after the long-term study found that people who used the diet pill had a higher cancer occurrence.

The approval of Belviq in 2012 was contingent upon the manufacturer conducting long-term safety studies to evaluate the risk of cardiovascular problems such as heart attacks and strokes. The studies tracked about 12,000 people over a five-year period and compared them to patients taking a placebo.

The study concluded in June 2018, but the focus was swiftly moved from cardiovascular concerns when the data revealed a link between Belviq and cancer. Several different cancers occurred more frequently among patients treated with Belviq. The FDA issued a Safety Communication on Jan. 14, 2020, warning the public of this risk and stating that the agency would continue to evaluate the clinical trial results.

On Feb. 13, 2020, the FDA called for the withdrawal of Belviq and Belviq XR due to the increased cancer occurrence in patients taking the diet pill, about 7.7% of Belviq users compared to 7.1% of nonusers. According to the FDA, one additional cancer diagnosis was observed per 470 patients taking Belviq for one year.

Cancers most often linked to Belviq use include:

• Pancreatic cancer
• Colorectal cancer
• Lung cancer

Belviq users may also be at increased risk for other cancers, including liver cancer and leukemia. Belviq was also linked to a higher rate of cancer-related death, multiple primary tumors, and metastatic disease.

FDA Recommendations

The FDA recommends that people stop taking Belviq and talk to their doctor about alternative weight loss treatments and programs after long-term safety studies found that patients taking Belviq had a higher occurrence of cancers, including pancreatic cancer, colorectal cancer, and lung cancer, compared to people taking a placebo.

The FDA is not recommending special screening for patients who have taken Belviq diet pills. However, as with any individual, regardless of prior Belviq treatment, standard screening recommendations for cancer should be followed.

Frequently Asked Questions About Belviq