Weight Loss Drug Belviq May Be Associated With Cancer, FDA Says – Everyday Health

Posted: January 20, 2020 at 7:56 pm

Results from a clinical trial assessing the safety of Belviq and Belviq XR (lorcaserin) show the drug may be associated with an elevated risk of tumors, but the cause of the cancer is uncertain, regulators say.

The U.S. Food and Drug Administration (FDA) issued a warning on January 14, 2020, that the prescription weight loss drug Belviq (lorcaserin) might be associated with an increased risk of cancer.

In a clinical trial following about 12,000 patients over five years, more patients taking lorcaserin were diagnosed with cancer compared with patients taking a placebo, according to the FDA.

At this time, the cause of the cancer is uncertain, and we cannot conclude that lorcaserin contributes to the cancer risk, the FDA said in its warning statement. However, we wanted to make the public aware of this potential risk.

A spokesperson for the FDA declined to provide additional information about the type of cancer or the magnitude of the risk while the analysis of the trial results are ongoing.

Tumors were observed with lorcaserin in two-year studies of rats,according to safety information on the FDA-approved label for the drug. These findings were based on doses far higher than doses used in humans, according to the label.

The relevance of these findings in animals to humans is unknown, Eisai Inc., the drugmaker that sells Belviq, said in a statement emailed to Everyday Health.

In humans, post-marketing adverse event reports do not suggest an increased risk of cancer, but we are working with the FDA to carefully assess the data from the recent clinical trial, Eisai stated.

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The FDA initially declined to approve lorcaserin in 2010 in part because of questions about the tumors found in rats. Regulators also had questions about cardiovascular side effects, including heart valve defects.

Lorcaserin won FDA approval in 2012 to aid weight loss in obese adults and in overweight adults who have health problems linked to excess weight, such asdiabetes, high blood pressure, and elevated cholesterol. The drug 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).

As a condition of approval, the FDA required Eisai to conduct several clinical trials known as post-marketing studies, including a long-term safety trial of cardiovascular side effects, the FDA said in the warning issued on potential cancer risks.

Some results of the trial of 12,000 patients,published September 20, 2018, in the New England Journal of Medicine(NEJM),found heart problems no more common with lorcaserin than with a placebo. After a median follow-up period of 3.3 years, roughly 2 percent of patients in both groups experienced things like heart attacks, strokes, and heart failure.

In this trial, a total of 215 patients on lorcaserin, or about 3.6 percent, developed cancer, researchers reported. So did 210 patients taking a placebo, or 3.5 percent, a difference too small to be statistically meaningful.

On the basis of these results, the potential cancer risk disclosed by the FDA was unexpected, says Frank Greenway, MD, the medical director at the Pennington Biomedical Research Center at Louisiana State University in Baton Rouge. Dr. Greenway wasnt involved in the NEJM trial, but has done other research on lorcaserin funded by Eisai.

The FDA did not tell how many more cancer cases were seen, Greenway says. We really do not know enough about the elevation of cancer risk to assess what the risk really is.

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Still, patients taking lorcaserin who dont lose 5 percent of their body weight after 12 weeks should stop, Greenway says. They should also discontinue use if they are taking the drug to improve weight-related health conditions like diabetes or high blood pressure and dont see anticipated improvements in these conditions, he advises.

One challenge for patients who might be worried about a potential cancer risk with lorcaserin is that obesity, too, is associated with an elevated risk of several cancers, says Beverly Tchang, MD, of the division of endocrinology, diabetes, and metabolism at NewYork-Presbyterian Weill Cornell Medical Center.

Excess body weight explains 3.9 percent of cancer cases worldwide, according to a study published December 2018 in CA: A Cancer Journal for Clinicians.

Being obese or overweight is associated with an increased risk of 13 cancers affecting the breast, colon and rectum, uterus, esophagus, gallbladder, kidney, liver, ovary, pancreas, stomach, and thyroid, brain and spinal cord, and blood cells.

More recently, some research has also tied excess weight to risk of prostate tumors as well as cancers of the mouth and throat, according to this study.

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With lorcaserin, its possible that any increased risk of cancer might be because patients on the drug see doctors more often or are more up-to-date on routine cancer screenings than other people, Dr. Tchang says.

Patients on lorcaserin may be more likely to see doctors or interact with medical care because they are already motivated to take charge of their health, whether by diet/exercise or adherence to cancer screening guidelines, Tchang says. If these patients are more likely to be on top of their cancer screening, then we will see a higher cancer incidence in this group.

Once details about any cancer risk are clearer, patients will need to weigh these risks against the cancer risks associated with obesity to make an informed decision about whether to start taking the drug or to discontinue use if theyre already on it, Tchang advises.

Certainly if the cancer risk associated with obesity is greater than that with the drug, then stopping lorcaserin and allowing obesity to develop could potentially increase a persons risk of cancer in the end, Tchang says.

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Weight Loss Drug Belviq May Be Associated With Cancer, FDA Says - Everyday Health

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