Recent Clinical Trial Findings Suggest Use Of The Weight-Loss Medicine Belviq Increased Risk Of Cancers
UPDATE: "FDA requests the withdrawal of the weight-loss drug Belviq, Belviq XR (lorcaserin) from the market" (2-13-2020 FDA Drug Safety Communication)
"Potential risk of cancer outweighs the benefits"
- Imbalances in specific cancers including pancreatic, colorectal, and lung contributed to the observed overall imbalance in cancer cases.
An FDA Belviq cancer warning alert, "Belviq, Belviq XR (lorcaserin): Drug Safety Communication - Due to Possible Increased Risk of Cancer", was issued on January 14, 2020. Belviq and Belviq XR are approved by FDA for use with a reduced-calorie diet and increased physical activity to help weight loss in adults who are obese or are overweight and have weight-related medical problems.
From that January 2020 FDA Belviq Drug Safety Communication we get the following:
ISSUE: The 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 we cannot conclude that [Belviq] contributes to the cancer risk. However, we wanted to make the public aware of this potential risk. We are continuing to evaluate the clinical trial results and will communicate our final conclusions and recommendations when we have completed our review.
This contextual information is provided by a related FDA document, "Safety clinical trial shows possible increased risk of cancer with weight-loss medicine Belviq, Belviq XR (lorcaserin)":
When approving [Belviq], we 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 [Belviq] were diagnosed with cancer compared to patients taking placebo, which is an inactive treatment. Our evaluation of this potential signal is ongoing, and at this time it is uncertain if [Belviq] increases the risk of cancer.
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A January 14, 2020 MedPage Today news report, "Diet Drug Possibly Linked to Cancer, FDA Says", present some background for the FDA Belviq cancer warning:
Some rat studies had suggested "mammary gland tumors in both sexes at clinically relevant exposures" and other tumor types in male rats at higher doses, according to an FDA review document [PDF, 425 pages] from 2012. But "[o]verall, malignancies were seen infrequently in the Phase 3 program. No formal cancer screening was conducted," it said, and the advisory committee "in general agreed that there is a sufficient safety margin for the drug when it is used at the concentrations intended for patients."
We will watch for any further FDA action as regards Belviq and report significant developments here.
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