其 他 安 全 警 示
|
| |
| The United States: Safety clinical trial shows possible increased risk of cancer with weight loss medicine Belviq, Belviq XR (lorcaserin) (English only) |
| |
The US Food and Drug Administration (FDA) is alerting the public that results from a clinical trial assessing safety show a possible increased risk of cancer with the weight management medicine Belviq, Belviq XR (lorcaserin). At this time, the cause of the cancer is uncertain, and FDA cannot conclude that lorcaserin contributes to the cancer risk. However, FDA wanted to make the public aware of this potential risk. FDA is continuing to evaluate the clinical trial results and will communicate the final conclusions and recommendations when FDA has completed its review.
Health care professionals should consider if the benefits of taking lorcaserin are likely to exceed the potential risks when deciding whether to prescribe or continue patients on lorcaserin.
Patients currently taking lorcaserin should talk to their health care professionals about the potential increased risk of cancer with use of lorcaserin in order to make the best decision about their medical treatment.
Lorcaserin is a prescription medicine approved by FDA in 2012. Lorcaserin works by increasing feelings of fullness so that less food is eaten. It is available as a tablet (Belviq) and an extended-release tablet (Belviq XR). When approving lorcaserin, FDA required the drug manufacturer, Eisai Inc., to conduct a randomized, double-blind, placebo-controlled clinical trial to evaluate the risk of heart-related problems. In this trial, which was conducted in approximately 12,000 participants over 5 years, more patients taking lorcaserin were diagnosed with cancer compared to patients taking placebo, which is an inactive treatment. The FDA’s evaluation of this potential signal is ongoing, and at this time it is uncertain if lorcaserin increases the risk of cancer.
Please refer to the following website in FDA for details:
http://www.fda.gov/drugs/drug-safety-and-availability/safety-clinical-trial-shows-possible-increased-risk-cancer-weight-loss-medicine-belviq-belviq-xr
In Hong Kong, the above products are not registered pharmaceutical products.
Ends/Wednesday, Jan 15, 2020
Issued at HKT 15:00
|
| |
|
