FDA Issues Public Warning Regarding Belviq & Belviq XR (Lorcaserin)

Possible Cancer Risk Associated with Belviq & Belviq XR (Lorcaserin)

The FDA is investigating a possible increased risk of cancer associated with the weight loss drug Lorcaserin which is currently marketed as: Belviq and Belviq XR.  The FDA announced on January 14, 2020, that the results of a clinical trial showed a possible increase risk of cancer. It has not been determined whether or not Lorcaserin is the actual cause and they are still analyzing the results. However, whatever the FDA saw, they felt the need to alert the public of the possibility of the increased risk.

What is Belviq & Belviq XR (Lorcaserin)?

Belviq/Belviq XR s is a serotonin 2C receptor agonist–a substance that activates the serotonin receptors in the brain to create a feeling of satisfaction or fullness.  It is indicated as a weight-loss medication that, when taken with regular diet and exercise, can help some adults living with extra weight, with a weight-related medical problem, or adults living with obesity, lose weight and keep it off. Belviq is taken orally. The recommended dosage of Belviq is one 10mg tablets taken twice per day.  The drug is manufactured and sold by Arena Pharmaceuticals.

FDA Approval History

In 2010 the FDA denied the Arena Pharmaceuticals ‘s application due to it concern it was causing tumors in rats when they were given 7x normal human dose. An FDA panel rejected Belviq in October 2010 because of studies linking Belviq and cancer. Those studies involved rodents who developed brain and breast cancer after being given doses of Belviq that were 7-times the dose a human would receive. Arena Pharmaceuticals assured the FDA that the tumors were rodent-specific and did not apply to humans.  In 2012, Arena Pharmaceuticals resubmitted the drug application with new data to assure the FDA there was not a significant cancer risk to humans. Belviq It was then approved for distribution. The panel ultimately voted 18-4 to approve Belviq in June 2012.

What should I do if I Take Belviq?

If you take Belviq, you should talk to your doctor about the risks and options available.  Common side-effects include low blood sugar (hypoglycemia), mental problems, slow heartbeat, headache, dizziness, back pain, vomiting, and upper respiratory tract infection. The FDA is requesting that you any “adverse events or side effects” by calling them at 1-800-332-1088.  Presumably they are interested in the unusual side-effects.

The possibility of an increased risk of cancer due to taking Lorcaserin is still under investigation.  If you have been diagnosed with cancer while taking Belviq, you may have legal rights.  Please feel free to call us for further information as information becomes available.

 

 

Warning never cease taking a prescribed medication without consulting your doctor first.  Ceasing a medication may cause more harm than it prevents in some circumstances. Nothing herein is to be construed as medical advice.

 

Author

Karen Sears

Karen Sears is a Marketing Assistant at Simmons and Fletcher, P.C. and a Criminal Justice Major at Sam Houston State University. She graduated from Tomball Memorial High School in May of 2019, and earned a Paralegal Certificate from the University of Texas at Austin in the Summer of 2019. She plans to attend law school after graduation.