Due to concerns about the risk of cancer from Belviq, federal health officials have requested that the manufacturers remove the prescription weight loss drug from the U.S. market.
The U.S. Food and Drug Administration (FDA) announced the Belviq recall on February 13, after new clinical trials linked use of the popular weight loss drug to an increased risk of developing several types of cancer, including pancreatic, colorectal and lung.
Lorcaserin, marketed under the brand name Belviq and Belviq XR, was first approved by the FDA in 2012, as a prescription weight loss drug for adults who are obese or who have weight related medical problems that prohibit them from losing weight through traditional diet and exercise. The active ingredients of the pill are intended to trigger chemical signals that make people want to eat less. However, Belviq side effects may actually increase the risk of cancer.
Belviq and Belviq XR are 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.
Despite pre-market testing that suggested Belviq exposure in rats could cause cancerous tumors, the FDA approved Eisai to start promoting the drug. However, the manufacturer was required to conduct a randomized, double-blind, placebo-controlled clinical trial in order to determine if there were any cancer or cardiovascular side effects in humans from Belviq.
According to findings of the study, which involved 12,000 subjects monitored over a period of five years, researchers identified an increased risk of cancer among Belviq users, when compared to those who received a placebo.
The conclusion of the study has indicated about 7.7% of Belviq patients had cancer diagnoses, compared with 7.1% of patients who got a placebo. Patients who were prescribed Belviq were found to be more frequently diagnosed with several types of tumors, including pancreatic, colorectal and lung cancers, according to the FDA recall.
Last month, the FDA issued a drug safety communication that questioned whether any benefits provided by the weight loss drug could possibly justify a risk of cancer. However, at the time the agency was unable to make a definitive correlation about the link between Belviq and cancer in the clinical trials.
Since the review of Eisai Co.’s study to the agency, Director of the FDA’s Center for Drug Evaluation and Research, Janet Woodcock, stated in the release the “potential risk of cancer associated with the drug outweighs the benefit of treatment.”
Eisai stated it has a different interpretation of the data from the trial and still believes the drug still has a “positive benefit-risk profile,” but it has agreed to withdraw it based on the FDA’s assessment.
Patients are being instructed to stop taking lorcaserin and talk to your health professionals about alternative weight-loss medicines and weight management programs. Patients are encouraged to dispose of the medications using a drug take back location.
The FDA is not recommending special cancer screening for patients who have taken lorcaserin, however they are encouraging patients to talk with their health care professional if you have questions.