Eisai Inc., the maker of Belviq and Belviq XR (lorcaserin) said in a February 13, 2020, statement that it is voluntarily withdrawing the drugs, even though the company didn’t find the same cancer signal in its own analysis of clinical trial data that the U.S. Food and Drug Administration (FDA) identified. “Patients should stop using the medication Belviq and Belviq XR (lorcaserin) and talk to their health care professionals about other treatment options for weight loss,” Janet Woodcock, MD, the director of the FDA’s Center for Drug Evaluation and Research, said in a February 13, 2020, statement. “Health care professionals should stop prescribing and dispensing Belviq and Belviq XR.” While patients who have taken Belviq should keep up with routine cancer screenings, the FDA didn’t recommend any additional screening specifically for people who have used the drug. The withdrawal comes one month after the FDA issued a warning that Belviq might be associated with an increased risk of cancer. At the time, regulators did not specify the type of cancer, nor did they quantify the potential increased risk. 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 said in January. RELATED: Are There Ways to Reduce Your Risk for Cancer?
Drug Removal Follows Clinical Trial Possibly Linking Belviq With 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 earlier warning statement. “However, we wanted to make the public aware of this potential risk.” A spokesperson for the FDA in January 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. In a statement announcing its request that Eisai withdraw Belviq from the market, the FDA said that its analysis of safety data from the trial found that 462 patients taking the drug, or 7.7 percent, developed cancer, compared with 423, or 7.1 percent, with placebo. Previously, 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. said in a statement emailed to Everyday Health last month. 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 said in January. In announcing its withdrawal of Belviq from the market, the company maintained that its interpretation of the trial results differed from the FDA’s and that it still believed the benefits of treatment outweighed any risks. RELATED: What Really Causes Obesity?
Past Research on Belviq Showed Statistically Insignificant Rise in Risks of Cancer and Heart Disease
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 as diabetes, high blood pressure, and elevated cholesterol. The drug works by increasing feelings of fullness so that less food is eaten. It was 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, said Frank Greenway, MD, the medical director at the Pennington Biomedical Research Center at Louisiana State University in Baton Rouge. Dr. Greenway wasn’t 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 said in January. “We really do not know enough about the elevation of cancer risk to assess what the risk really is.” RELATED: Obesity Triggering Rising Cancer Rates in Millennials
The Known Connection Between Obesity and Cancer
Still, patients taking lorcaserin who don’t lose 5 percent of their body weight after 12 weeks should stop, Greenway said. They should also discontinue use if they are taking the drug to improve weight-related health conditions like diabetes or high blood pressure and don’t see anticipated improvements in these conditions, he advised. 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, said Beverly Tchang, MD, of the division of endocrinology, diabetes, and metabolism at NewYork-Presbyterian Weill Cornell Medical Center in New York City. Excess body weight explains 3.9 percent of cancer cases worldwide, according to a study published December 2018 in . 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. RELATED: What Are the Risk Factors for Cancer, and Can You Prevent It?
Theories on Elevated Cancer Risk in People Using Belviq
With lorcaserin, it’s 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 said in January. “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 said. “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 they’re already on it, Tchang recommended. “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 person’s risk of cancer in the end,” Tchang said.
title: “Weight Loss Drug Belviq Pulled From Market For Possible Cancer Risk” ShowToc: true date: “2022-12-20” author: “Allan Leffler”
Eisai Inc., the maker of Belviq and Belviq XR (lorcaserin) said in a February 13, 2020, statement that it is voluntarily withdrawing the drugs, even though the company didn’t find the same cancer signal in its own analysis of clinical trial data that the U.S. Food and Drug Administration (FDA) identified. “Patients should stop using the medication Belviq and Belviq XR (lorcaserin) and talk to their health care professionals about other treatment options for weight loss,” Janet Woodcock, MD, the director of the FDA’s Center for Drug Evaluation and Research, said in a February 13, 2020, statement. “Health care professionals should stop prescribing and dispensing Belviq and Belviq XR.” While patients who have taken Belviq should keep up with routine cancer screenings, the FDA didn’t recommend any additional screening specifically for people who have used the drug. The withdrawal comes one month after the FDA issued a warning that Belviq might be associated with an increased risk of cancer. At the time, regulators did not specify the type of cancer, nor did they quantify the potential increased risk. 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 said in January. RELATED: Are There Ways to Reduce Your Risk for Cancer?
Drug Removal Follows Clinical Trial Possibly Linking Belviq With 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 earlier warning statement. “However, we wanted to make the public aware of this potential risk.” A spokesperson for the FDA in January 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. In a statement announcing its request that Eisai withdraw Belviq from the market, the FDA said that its analysis of safety data from the trial found that 462 patients taking the drug, or 7.7 percent, developed cancer, compared with 423, or 7.1 percent, with placebo. Previously, 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. said in a statement emailed to Everyday Health last month. 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 said in January. In announcing its withdrawal of Belviq from the market, the company maintained that its interpretation of the trial results differed from the FDA’s and that it still believed the benefits of treatment outweighed any risks. RELATED: What Really Causes Obesity?
Past Research on Belviq Showed Statistically Insignificant Rise in Risks of Cancer and Heart Disease
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 as diabetes, high blood pressure, and elevated cholesterol. The drug works by increasing feelings of fullness so that less food is eaten. It was 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, said Frank Greenway, MD, the medical director at the Pennington Biomedical Research Center at Louisiana State University in Baton Rouge. Dr. Greenway wasn’t 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 said in January. “We really do not know enough about the elevation of cancer risk to assess what the risk really is.” RELATED: Obesity Triggering Rising Cancer Rates in Millennials
The Known Connection Between Obesity and Cancer
Still, patients taking lorcaserin who don’t lose 5 percent of their body weight after 12 weeks should stop, Greenway said. They should also discontinue use if they are taking the drug to improve weight-related health conditions like diabetes or high blood pressure and don’t see anticipated improvements in these conditions, he advised. 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, said Beverly Tchang, MD, of the division of endocrinology, diabetes, and metabolism at NewYork-Presbyterian Weill Cornell Medical Center in New York City. Excess body weight explains 3.9 percent of cancer cases worldwide, according to a study published December 2018 in . 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. RELATED: What Are the Risk Factors for Cancer, and Can You Prevent It?
Theories on Elevated Cancer Risk in People Using Belviq
With lorcaserin, it’s 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 said in January. “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 said. “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 they’re already on it, Tchang recommended. “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 person’s risk of cancer in the end,” Tchang said.
