- The company that manufactures the weight loss medication Belviq has agreed to voluntarily withdraw the drug.
- The move came after Food and Drug Administration (FDA) officials announced that clinical trials have indicated the drug could raise the risk of certain cancers.
- Officials at Eisai Inc. disputed the FDA’s findings but said they would comply with the agency’s request.
- A weight loss expert told Healthline that there are only four branded drugs approved for long-term treatment of obesity, so the withdrawal could have an impact on people who use Belviq.
The Food and Drug Administration (FDA) and the manufacturer of the weight loss medication Belviq and Belviq XR have agreed to a
People using the medications were found to have higher rates of pancreatic, colorectal, and lung cancer, among other types of cancer, the FDA reported.
“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,” said
The FDA urged people using lorcaserin, marketed as Belviq and Belviq XR by the Japanese pharmaceutical company Eisai Inc., to immediately stop using the drugs.
“Healthcare professionals should stop prescribing and dispensing Belviq and Belviq XR,” the FDA added.
The FDA advised people to consult with their healthcare professionals and seek other weight loss treatment options.
However, the agency didn’t call for special cancer screenings of people who’ve used the drugs.
“Standard screening recommendations for cancer should be implemented for any patient, regardless of prior Belviq treatment,” said Woodcock.
In a statement, Eisai Inc. officials said it disagreed with the FDA’s interpretation of the study, maintaining that Belviq and Belviq XR “continue to have a positive benefit-risk profile in the patient population for which they are indicated.”
Eisal Inc. officials added that “prior to and following market approval of Belviq, the product has been evaluated in more than 30 clinical trials involving over 22,000 patients over the last 15 years.”
“However, based on the change in FDA’s risk-benefit assessment and as requested by the agency, Eisai has agreed to voluntarily withdraw the products from the U.S. market,” company officials said. “Eisai respects the FDA’s decision and is working closely with the agency on the withdrawal process.”
The FDA first issued a
Belviq was approved by the FDA in 2012 as an add-on weight loss medication.
It’s intended to be used in conjunction with a reduced-calorie diet and increased physical activity for adults who have overweight or obesity and at least one weight-related comorbidity.
The latter group can include diabetes, hypertension, cardiovascular disease, stroke, sleep apnea, gallbladder disease, gout, and osteoarthritis.
FDA approval of Belviq was conditioned on Eisai Inc. conducting a randomized, double-blind, placebo-controlled clinical trial to evaluate the risk of cardiovascular disease associated with the use of the medication.
The trial was conducted among 12,000 participants over 5 years and ended in June 2018.
The FDA’s review of data from the trial found that more people taking the medication (7.7 percent) were diagnosed with cancer compared to those taking a placebo (7.1 percent).
During the trial, one additional cancer per 470 participants treated with the medication for 1 year was observed.
No increase in cardiovascular risk — the original focus of the study — was associated with Belviq use.
Dr. Craig Primack, FACP, FAAP, FOMA, president of the Obesity Medicine Association and founding partner at the Scottsdale Weight Loss Center in Arizona, told Healthline that withdrawing Belviq will have a significant impact on patient care.
“This is one of only four branded drugs that have been approved for long-term use in treating obesity,” said Primack.
“It may be the fourth-most used of those drugs, but for patients using it, it works quite well,” Primack added. “For those patients, this will be a big detriment.”
Further complicating treatment is that while Belviq costs about $120 per month in Arizona, Saxenda — one of the remaining alternatives — costs $1,150 to $1,250 monthly.
“With obesity, we don’t have that many drugs, and there’s not one drug for everyone,” said Primack.
He noted that about two-thirds of his patients take obesity medication of some kind.
“For high blood pressure, you might have 140 drugs, for example. In the world of weight loss, we only have a couple, so now we have one less in the toolbox,” he said.