FDA Requests Voluntary Withdrawal of Weight-Loss Medication After Clinical Trial Shows an Increased Occurrence of Cancer
在临床试验表明癌症发病率增加后FDA要求自愿撤回减肥药
The following quote is attributed to Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research:
“Public health and safety of drugs that Americans rely on is a top priority at the FDA – both before and after approval. We’re taking steps to notify the public about a particular weight-loss medication and have requested that the company voluntarily withdraw the product from the market because our review of the full clinical trial results shows that the potential risk of cancer associated with the drug outweighs the benefit of treatment. The company has submitted a request to voluntarily withdraw the drug.”
“As noted in a new Drug Safety Communication issued today, patients should stop using the medication Belviq and Belviq XR (lorcaserin) and talk to their health care professionals about other treatment options for weight loss. Health care professionals should stop prescribing and dispensing Belviq and Belviq XR.”
“The FDA is not recommending special screening for patients who have taken Belviq. Standard screening recommendations for cancer should be implemented for any patient, regardless of prior Belviq treatment.”
“The agency’s actions follow our alert to the public earlier this year about the possible risk of cancer associated this medication based on preliminary analysis of the clinical trial data.”
“We will continue to track safety issues with medications on the market and use science and data as our guide to act quickly when we have determined that the risks associated with drugs are greater than the benefits of treatment.”
The U.S. Food and Drug Administration today issued a Drug Safety Communication following a data analysis from a postmarket clinical trial of Belviq and Belviq XR (lorcaserin) shows that an increased occurrence of cancer. The Drug Safety Communication also includes recommendations for patients and health care professionals.
The FDA has requested Eisai Inc. to voluntarily withdraw Belviq and Belviq XR from the U.S. market, and the company has submitted a request to voluntarily withdraw the drug.
The FDA approved Belviq in 2012 as an adjunct (add-on) therapy to a reduced-calorie diet and increased physical activity for chronic weight management among adults who were obese or overweight with at least one weight-related comorbidity. At that time, the agency required the drug manufacturer to conduct a randomized, double-blind, placebo-controlled clinical trial to evaluate the risk of cardiovascular disease. The FDA’s review of safety data from the trial found that more patients taking the medication (462; 7.7%) were diagnosed with cancer compared to those taking a placebo, an inactive treatment (423; 7.1%).
The trial was conducted among 12,000 participants over five years, and ended in June 2018. A range of cancer types was reported. Several different types of cancers occurred more frequently among patients treated with Belviq, including pancreatic, colorectal, and lung cancer. During the trial, one additional cancer per 470 patients treated with the medication for one year was observed.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
