Recalled Belviq Should Be Added To FDA List of Withdrawn Drugs to Prevent Compounding Pharmacy Use: Petition

The consumer watchdog group Public Citizen is calling on the FDA to add the active pharmaceutical ingredient in Belviq to an official list of banned or withdrawn medications, to prevent the recalled weight loss drug from being used by compounding pharmacies.

Belviq (lorcaserin) was introduced in 2012, as the first new diet drug approved in years, after a steady stream of recalls and problems associated with other weight loss treatments. However, following a large number of reports involving users diagnosed with cancer in post-marketing studies, the FDA required the drug maker to issue a Belviq recall in February 2020.

According to Public Citizen press release issued on April 13, the FDA has not yet added lorcaserin to its list of withdrawn drugs.

The group indicates the list is consistently out-of-date, often by years, which means the banned drugs can still legally be made by physicians and compounding pharmacies for special orders, even though the agency has recalled Belviq from the market due to the unreasonable risk that users may develop cancer.

Public Citizen has filed an FDA petition (PDF) to force action on the issue, calling on the agency to immediately add lorcaserin to the withdrawn drug list, and for the FDA to simultaneously update the list whenever a drug is withdrawn or removed from the market due to safety or effectiveness concerns.

“The FDA in most cases over the past two decades, has taken at least several years to update the list of withdrawn drugs after the agency determined that a drug was removed from the market because it was unsafe or effective,” Dr. Michael Carome, director of Public Citizen’s Health Research Group, said in the press release. “Such foot-dragging poses unacceptable and avoidable risks to patients and public health.”

Belviq Cancer Lawsuits

The petition comes as a growing number of Belviq lawsuits continue to be filed against Eisai Inc. And Arena Pharmaceuticals in courts nationwide, each involving allegations that former users of the weight loss medication developed cancer, which could have been avoided if the drug makers had properly researched their weight loss treatment and warned consumers about the risks.

The litigation emerged after data was released from an expert analysis of the CAMEILLIA-TIMI 61 Trial in June 2019, which was intended to look at the effectiveness and side effects of Belviq, including the largest concern at the time: cardiovascular risks. However, data actually identified a potential link between Belviq and pancreatic cancer, colorectal cancer and lung cancer.

The FDA issued the first Belviq cancer warnings in January 2020, and several weeks later it was determined the weight loss drug needed to be removed from the market.

There are currently at least 13  pending in 12 different U.S. District Courts nationwide, each involving similar claims the manufacturers failed to adequately research the medication or provide adequate warnings for users and the medical community. However, the number of claims is expected to increase dramatically in the coming years.

Although it has been more than a year, many former users are still unaware that Belviq was recalled or that cancer diagnosed in recent years may have been caused by the medication. In addition, it is widely expected that additional cases will arise over the next few years among former users of the recalled weight loss treatment.