Belviq Cancer Recall Leaves Questions About How Diet Drug Was Ever Approved

After a Belviq recall was issued earlier this year, due to an increased risk of cancer linked to the controversial diet drug, serious questions have emerged over why the medication was allowed on the market only a few years earlier.

Belviq and Belviq XR (lorcaserin) are new generation, prescription weight-loss medications introduced in 2012, following a long history of diet drug recalls and problems linked to earlier products.

Although many health experts raised concerns about the potential side effects of Belviq and lack of data establishing its effectiveness, federal regulators approved the medication with the requirement the drug maker conduct additional post-marketing clinical trials, while it was being sold to U.S. as a safe product.

While continuing to study and evaluate the diet drug, the Japanese drugmaker Eisai Co. began aggressively promoting Belviq to consumers in 2013, and the medication quickly became a popular option for individuals looking to loose weight, with more than 600,000 prescriptions filled in 2015 alone, when sales reached an estimated $50 million per year.

The future prospects for the medication hit a screeching halt last year, after a preliminary analysis of data from the post-marketing study required by the FDA revealed that there may be a link between Belviq and cancer, with users of the diet drug experiencing increased incidence of pancreatic cancer, colorectal cancer, lung cancer and other injuries.

The diet drugs were manufactured by Japanese drugmaker Eisai Co., who began selling the medication in the U.S. in 2013. The medication quickly became a popular choice among prescribing doctors, with more than 600,000 prescriptions filled in 2015 alone, with sales reaching an estimated $50 million.

In January 2020, the FDA issued a warning about the potential Belviq cancer risk, and several weeks later the agency recommended that the manufacturer remove the diet drug from the market.

However, safety signals came long before the Belviq cancer recall.

Belviq Problems

After an FDA advisory panel decided to approve the medication in April 2012, the consumer watchdog group Public Citizen warned that Americans would face an unnecessary risk of problems from Belviq, predicting that it would eventually be removed from the market like a number of other previously-approved weight-loss drugs.

In July 2019, an expert analysis of the CAMEILLIA-TIMI 61 Trial was published by the American College of Cardiology. The study looked at the effectiveness and side effects of Belviq, including the largest concern at the time: cardiovascular risks.

While not publicly announced until months later, the data contained concerning indications about a potential link between Belviq and pancreatic cancer, colorectal cancer and lung cancer. However, the FDA did not issue Belviq cancer warnings until January 2020, and several weeks later it was determined that the weight loss drug needed to be removed from the market.

Even before then, at the time the medication was approved, the FDA required the drug makers to conduct a five year follow up study involving about 12,000 participants to evaluate the potential heart risks associated with the medication. However, researchers identified at least 462 individuals treated with Belviq who were diagnosed with 520 different primary cancers over a median follow up time of three years and three months.

A number of Belviq recall lawyers are now pursuing litigation against the drug maker on behalf of individuals diagnosed with cancer, as well as class action claims that seek reimbursement for the premium price paid by users of the recalled diet drug, who now require medical monitoring for cancers that may surface months, or even years after last exposure.