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.
RELATED: What Really Causes Obesity?
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.
RELATED: Obesity Triggering Rising Cancer Rates in Millennials
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.
RELATED: What Are the Risk Factors for Cancer, and Can You Prevent It?
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.
Read more from the original source:
Weight Loss Drug Belviq May Be Associated With Cancer, FDA Says - Everyday Health
- There's evidence that exercise after consuming olive oil could trigger changes linked to longevity - Insider - INSIDER - February 27th, 2020
- Sen. Markey Encourages National Health Institute To Study Impact of Technology on Children - framinghamsource.com - February 27th, 2020
- How to be an ally to those with eating disorders - University of Virginia The Cavalier Daily - February 27th, 2020
- The Real-Life Diet of Shake Shacks Executive Chef, Who Taste-Tests Burgers Between Marathons - GQ - February 27th, 2020
- At Eagles Trace, Relationships Thrive Through Connection - Patch.com - February 27th, 2020
- Simple Diet Changes Helped This Guy Build Muscle and Get Shredded in 6 Weeks - menshealth.com - February 27th, 2020
- Researchers found a cure for diabetes (in lab mice) - The Next Web - February 27th, 2020
- I ate like a toddler for a week, and it transformed my relationship with breakfast - Insider - INSIDER - February 27th, 2020
- After Sharing Struggles With Infertility, the Food Network's Katie Lee Has a Baby on the Way! - POPSUGAR - February 27th, 2020
- 5 reasons you are exercising and still not losing weight - Pulse Live Kenya - February 27th, 2020
- 5 Lifestyle Tweaks That Will Dramatically Improve One's Wellbeing, with Tomomi Tsuchio and Dr. William Seeds - Thrive Global - February 27th, 2020
- Trumps Doctor Thought He Had a Ticket to Congress. It Hasnt Been So Easy. - The New York Times - February 27th, 2020
- Health-benefits Of Human Anatomy From Science Exercise Routine - My Duhawk - February 27th, 2020
- Lose up to two stone in ten weeks - Galway Advertiser - February 27th, 2020
- Lifestyle Choices and Prostate Cancer - Cancer Therapy Advisor - February 27th, 2020
- 5 Effects of High Blood Pressure on Your Body - LIVESTRONG.COM - February 27th, 2020
- Former White House physician hid cauliflower in Trumps mashed potatoes to improve his diet - AlterNet - February 27th, 2020
- Baboons captured after running loose in Sydney's inner west - The Sydney Morning Herald - February 27th, 2020
- Weight loss story: This guy followed the Keto diet and lost 11 kilos in just 2 months! This is his diet - Times of India - February 24th, 2020
- Five ways to improve flexibility - The Guardian - February 24th, 2020
- How to lose belly fat: 6 easy ways to burn visceral fat, feel fitter and reveal your abs in 2020 - T3 - February 24th, 2020
- The importance of checking your blood pressure regularly - FOX 31 Denver - February 24th, 2020
- Staying heart healthy: What you need to know at the end of Heart Health Month - KRDO - February 24th, 2020
- Two Million People Could Be Diabetic In The Next 5 Years: Know The Best Preventive Tips For Keeping Type 2 Diabetes Away - Doctor NDTV - February 24th, 2020
- Signs Of Heart Disease When There Are No Obvious Symptoms - KERA News - February 24th, 2020
- Mediterranean diet scores another win for longevity by improving microbiome - CNN - February 24th, 2020
- The Sirtfood Diet: The 411 On Adeles Weight Loss Method - Momtastic - February 24th, 2020
- Signal of high blood pressure that you can find surprisingly in your hair - NewsDio - February 24th, 2020
- Prevention is key to maintaining a healthy heart - centraljersey.com - February 22nd, 2020
- Human Condition: When that long walk for exercise takes you to the ice cream parlor - The Advocate - February 22nd, 2020
- The Old Guy: Loving support for a partner with health concerns - SILive.com - February 22nd, 2020
- Foods That Help Ease Menopausal Symptoms - Everyday Health - February 22nd, 2020
- The Full List of Foods You Can Eat on the Noom Diet - GoodHousekeeping.com - February 22nd, 2020
- Kelly Ripa, 49, Quit Drinking and Eats an Alkaline Diet to Look and Feel Her Best - Prevention.com - February 22nd, 2020
- Mark Spitz: The Real-Life Diet of the Legendary Swimmer Who Still Does Imaginary Races Against Michael Phelps - GQ - February 22nd, 2020
- Father Forced His 9-Year-Old Daughter to Adopt Strict Diet and Exercise Regimen - Distractify - February 22nd, 2020
- Looking to Build a Stronger Butt? Here Are 5 Foods to Eat (and 2 to Avoid) - LIVESTRONG.COM - February 22nd, 2020
- How to lose visceral fat: The alternative exercise proven to reduce harmful belly fat - Express - February 22nd, 2020
- Fad of Matching Diet to DNA Ineffective, New Study Shows - The Great Courses Daily News - February 22nd, 2020
- Chin up vs pull up: what's the difference, muscles worked and WHAT IS THE BEST ONE? - T3 - February 22nd, 2020
- Flexitarian diet: All you need to know about this balanced diet option - Republic World - Republic World - February 22nd, 2020
- The Irish Times view on the Mediterranean diet: good for the gut - The Irish Times - February 22nd, 2020
- Benefits, fun can be found by getting fit in a group - The Robesonian - February 22nd, 2020
- DNA Diet Hailed as Key to Weight Loss, But Don't Bet Your Genes On It - Celebrity Health & Fitness - February 22nd, 2020
- Tips on using diet and exercise to prevent heart disease - WISHTV.com - February 19th, 2020
- Exercise Makes It Easier To Maintain A Healthy Diet, Doesnt Cause Increased Appetite - Study Finds - February 19th, 2020
- Mediterranean diet scores another win for longevity by improving microbiome - KTVZ - February 19th, 2020
- As Wave of Baby Boomers Enter Retirement, Journey Capital and SilverPoint Senior Living Team Up to Build Modern Senior Living Communities - PRNewswire - February 19th, 2020
- Personal trainers given tools to spot 'red flags' of eating disorders - The Sydney Morning Herald - February 19th, 2020
- How to eat, sleep, train and boost your mood during your menstrual cycle - Telegraph.co.uk - February 19th, 2020
- Weight loss tips: How to combine intermittent fasting & keto to lose weight, as per this guy who lost 33 kg - GQ India - February 19th, 2020
- Joel Reece encourages students to know their eating habits and avoid excessive refined carbohydrates - Ke Alakai - February 15th, 2020
- What Really Happens to Your Body When You Lose 10 Pounds - LIVESTRONG.COM - February 15th, 2020
- Gearing up for my annual battle with cabin fever - Lake Placid Diet by Andy Flynn - LakePlacidNews.com | News and information on the Lake Placid and... - February 15th, 2020
- Various classes offer students and community opportunities to practice mindfulness - University of Virginia The Cavalier Daily - February 15th, 2020
- What we can all learn from Henry Cavill's health and wellbeing rituals - harpersbazaar.com - February 15th, 2020
- Using the bodys natural cycle to improve shift workers health - Medical News Today - February 15th, 2020
- Disordered Eating and Compulsive Exercise in Collegiate Athletes: Applications for Sport and Research - United States Sports Academy Sports Journal - February 15th, 2020
- Springfield Hospital Looks To Sever Ties With Clinics In Bankruptcy Plan - Vermont Public Radio - February 15th, 2020
- Following a keto diet could weaken your bones and increase your risk of injury - Luton Today - February 15th, 2020
- Start your Health Journey with Live Well Exercise Clinic - North Shore News - February 15th, 2020
- NewsRadio 1120 KMOX Released an Interview With STL Beds Owners and Family Members Dave and Doug Belleville - PR Web - February 15th, 2020
- Leg Cramps on Keto: Causes, Treatment, and More - Healthline - February 15th, 2020
- Horoscope today: Here are the astrological predictions for February 14 - Mumbai Mirror - February 15th, 2020
- Gwen Stefani Reveals 15 Things She Does To Look So Young - TheThings - February 15th, 2020
- Everything you need to know about carbs - 9Honey - February 15th, 2020
- The Best Diet And Fitness Tips Kate Middleton Swears By - Women's Health - February 12th, 2020
- Is there a connection between diabetes and heart health? - Monitor - February 12th, 2020
- FHN News: 20 tips for a healthy heart this Valentines Day - Freeport Journal-Standard - February 12th, 2020
- Bob Roper | The fires of California: Past the tipping point? - YubaNet - February 12th, 2020
- This Research-Backed Trick Can Help Healthy Eating Stick - Runner's World - February 12th, 2020
- How to live longer: Do this much exercise each week to increase your life expectancy - Express - February 12th, 2020
- Steps to Improve and Maintain Your Heart Health - DeKalb Daily Chronicle - February 12th, 2020
- This Man Lost 82 Pounds Through Fasting and Tackling the Carnivore Diet - msnNOW - February 12th, 2020
- Reducing the Risks - outsmartmagazine.com - February 12th, 2020
- Intermittent fasting is the best diet for weight loss, but the Mediterranean diet is easier to stick to and healthier overall, study finds - Business... - February 12th, 2020
- What is the alkaline diet and can it lead to weight loss? - ABC News - February 12th, 2020
- Embracing Your Postpartum Body And Ignoring The Pressure To "Bounce Back" - GirlTalkHQ - February 12th, 2020
- Phillip Schofield fitness: This Morning presenter reveals how he stays in shape - Express - February 12th, 2020
- Diabetes support group's good start The Voice - The Spalding and South Holland Voice - February 12th, 2020