By Jacqueline
Howard, CNN Updated 10:46 AM ET, Wed January 15, 2020
The weight loss medicine Belviq might be associated with an
increased risk of cancer, the FDA says.
(CNN)The US Food and Drug Administration warns that
prescription weight loss medicine Belviq might be associated with an increased
risk of cancer.
The findings were the result of a clinical
trial assessing the safety of the drugs Belviq and Belviq RX, or lorcaserin,
the FDA announced on Tuesday.
"At this time, the cause of the cancer is
uncertain, and we cannot conclude that lorcaserin 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,"
the FDA said in its announcement.
The agency went on to note that health care
professionals should consider if the benefits of taking lorcaserin exceed the
potential risks for a patient, and that patients currently taking the drug
should talk to their doctors about the potential increased risk of cancer.
The drug manufacturer, Eisai Inc., responded
to the FDA's announcement in a written statement on Wednesday.
"Patient safety is Eisai's priority and
we will continue to work closely with the FDA to evaluate the clinical trial
results," the statement said. "We recommend patients speak directly
with their health care professional in order to make the best decision about
their medical treatment. As indicated in the FDA's communication, at this time,
the FDA and Eisai cannot conclude that BELVIQ increases the risk of
cancer."
Lorcaserin, an oral medication, was approved
by the FDA in 2012 and made available by prescription the
year following to help weight loss in adults who are obese or
are overweight and have weight-related medical problems, according to the FDA.
Lorcaserin -- available as Belviq, which is
a twice-daily tablet, and
Belviq XR, which is an extended-release once-daily tablet -- works by increasing
feelings of fullness so that you eat less food.
The FDA said in its announcement that, when
approving lorcaserin, the agency 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 the trial, conducted in about
12,000 participants over five years, more patients taking lorcaserin were
diagnosed with cancer compared to patients taking a placebo, which was an
inactive treatment.
"Our evaluation of this potential signal
is ongoing, and at this time it is uncertain if lorcaserin increases the risk
of cancer," the FDA said.
Weight loss drugs approved
for long-term use include orlistat (brand name Xenical), lorcaserin (Belviq) and liraglutide
(Saxenda) as well as the combination drugs naltrexone-bupropion (Contrave) and
phentermine-topiramate (Qsymia).
In one recent study, these drugs helped
overweight or obese people lose at least 5% of their body weight at
the end of a year -- that's at least 10 pounds if you weigh 200 -- compared
with a placebo. Qsymia and Saxenda were associated with the highest odds of
achieving that amount of weight loss.
For many, losing 5% to 10% of your body weight
is associated with improved blood pressure, triglycerides and blood sugar,
factors that lower the risk for heart disease and diabetes.
CNN's Lisa Drayer contributed to this report.
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