Lorcaserin and phenterminetopiramate for weight loss jmcp. These documents will be updated when new clinical data warrant additional. The development of a potentially lifethreatening serotonin syndrome or neuroleptic malignant syndrome nmslike reactions have been reported during use of. Lorcaserin, a novel selective 5ht2c receptor agonist, is approved by the us food and drug administration fda for weight management in combination with lifestyle modification for adults with obesity and adults with overweight and. Pdf obesity is a major comorbidity with hypertension and diabetes mellitus. This is a 19week, multicenter, randomized, phase 2 clinical study comparing the efficacy of lorcaserin 10mg, b. It acts selectively at this receptor subtype with minimal activation of 5htr or 5htr receptors. Belviq and belviq xr are approved by fda for use with a reducedcalorie diet and increased physical activity to help weight loss in adults who are obese or are overweight and have weightrelated medical problems. February 2020, the us food and drug administration fda asked the manufacturer of lorcaserin to voluntarily withdraw lorcaserin from the united states market because of clinical trial data showing an increased. Randomized placebocontrolled clinical trial of lorcaserin. The efficacy of this drug in reducing body weight and improving metabolic parameters of obese patients has been demonstrated in two recent clinical trials. Indication for lorcaserin use is obesity or overweight, which is accompanied with some cardiometabolic disorders e. The safety and efficacy of lorcaserin 10 mg twice daily for.
Health care professionals should stop prescribing and dispensing lorcaserin to patients. Lorcaserin belviq is a drug that promotes weight loss by affecting the brains hypothalamus. Fda requests withdrawal of weightloss drug due to cancer risk. Up to 3 weeks will be allowed for the screening period and a week treatment phase, with a 3week followup period, with scheduled visits during study weeks 14 and 16. The fda stated that the weight loss data passed fda standards for efficacy and that the drug did not have cancer risks based on clarifications in the data. Jan 02, 2017 this is a 19week, multicenter, randomized, phase 2 clinical study comparing the efficacy of lorcaserin 10mg, b. Weightloss drug belviq increases risk of cancer, fda warns.
In response, arena submitted more material to the agency, including a trial of the drug in. A study to evaluate the effect of longterm treatment with belviq lorcaserin hcl on the incidence of major adverse cardiovascular events and conversion to type 2 diabetes mellitus in obese and overweight subjects with cardiovascular disease or multiple cardiovascular risk factors full text view. When taken as directed, it causes a lowtomoderate incidence of adverse drug events compared with other weightloss agents. Cv safety trial for lorcaserin picks up cancer signal. The fda approved lorcaserin belviq lorcaserin hcl buy belviq. Lorcaserin belviq national drug monograph june 20 va pharmacy benefits management services, medical advisory panel, and visn pharmacist executives. The fda conducted a thorough evaluation of belviq effectiveness and approved marketing of this anorexigenic drug in 2012. Lorcaserin is used together with diet and exercise to treat obesity. In three clinical trials, lorcaserin was found to be efficacious for adjunctive therapy and maintenance of weight loss. The effect of lorcaserin in geriatric populations is unknown, as most patients in the three published clinical trials were 65 years of age or younger. The maker of lorcaserin has indicated it will continue to seek u. Randomized placebocontrolled clinical trial of lorcaserin for weight loss in type 2 diabetes mellitus. A safety clinical trial shows a possible increased risk of cancer with the weightloss drug belviq, belviq xr. The advisory panel voted 1941 to recommend lorcaserin to the fda.
In october 2010, the fda turned down lorcaserin, citing the modest weight loss and worries about its potential to cause cancer. Fda requests the withdrawal of the weightloss drug belviq, belviq. For more information, see fda drug safety communication. Despite the fact that the central office of the developer and manufacturer of lorcaserin drug is located in the usa san diego, ca, lorcaserin tablets are manufactured in switzerland. Fda requests lorcaserin be withdrawn from the market owing to a potential risk of cancer. The company hopes to win fda approval to market the new. Jul 14, 2010 diet drug lorcaserin safe, effective, study finds. Fda briefing document nda 22529 lorcaserin hydrochloride. In bloomdiabetes mellitus dm, there was also an increase in adverse events. The fda has released a public alert regarding the safety of weight loss drug lorcaserin after a clinical trial assessing safety of the drug showed that it. Contains nonbinding recommendations draft guidance on lorcaserin hydrochloride recommended mar 2015 this draft guidance, once finalized, will represent the food and drug administration s fdas. Do not breastfeed while you take this medicine lorcaserin tablets. May 08, 2012 the fda has posted briefing documents for thursdays meeting of the endocrinologic and metabolic drugs advisory committee to reconsider the new drug application for lorcaserin lorqess, arena. This is not a list of all drugs or health problems that interact with this medicine lorcaserin tablets.
Fda defined vhd by subgroup, phase 3 trials pooled, baseline weight. Lorcaserin in the treatment of cocaine use disorder full. Drug safety communication due to possible increased risk of cancer, was issued on january 14, 2020. Lorcaserin, a 5ht 2c agonist, has demonstrated efficacy in patients who are obese or are overweight with associated comorbidities. Fda accepts resubmission of lorcaserin new drug application. The fda approval of lorcaserin required the manufacturer to conduct a randomized, doubleblind, placebocontrolled clinical trial to evaluate the. Phentermine and fenfluramine, components of the weight loss combination. The safety and effectiveness of lorcaserin in adult patients without. The cause of the cancer is uncertain, and the fda cannot conclude that lorcaserin. Belviq is indicated as an adjunct to a reducedcalorie diet and increased physical activity for chronic weight. Fdas analysis of the study found that during the course of the trial, 462 7. January 14, 2020 the fda announced that results from a clinical trial assessing safety show a possible increased risk of cancer with the weight management medicine belviq, belviq xr lorcaserin. Oct 18, 2014 of equal concern is the finding that lorcaserin seems to be associated with an increased incidence of depression or 1.
In this trial of 12,000 participants over 5 years, more patients taking lorcaserin were diagnosed with cancer compared to patients taking placebo. Lorcaserin was previously shown to be efficacious for weight loss, which led to approval by the fda for longterm weight management in obese or overweight patients who had at. Since belviq xr has the potential to impair cognitive function, patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain that belviq xr therapy does. The primary outcome of patient weight loss in the 3 trials satisfied the fda categorical benchmark but patient outcomes in the trials failed to achieve the fda mean benchmark of patient weight loss. The fda has approved lorcaserin for chronic weight loss management in adults as an adjunct to diet and exercise. A study to evaluate the effect of longterm treatment with. May 10, 2012 new diet drug lorcaserin wins vote from fda panel. Lorcaserin is effective for weight loss in obese patients with and without type 2 diabetes, although its specific role in the management of obesity is unclear at this time. Jun 27, 2012 fda approval history for belviq lorcaserin used to treat obesity.
Jun 10, 2014 lorcaserin is a prescription medication used to help adults who are obese or who are overweight and have weightrelated medical problems to lose weight and keep from gaining back that weight. Generic name, side effects and where to buy lorcaserin is one of the many diet pills and weight loss drugs waiting approval from the us fda or food and drug administration. The fda panelist recommended that postmarketing studies regarding potential heart valve issues be completed. The fda asked the maker of weightloss drug belviq lorcaserin to take it off the market after a clinical trial showed an association with an increased risk of cancer.
The fda approved lorcaserin 10 mg twice daily in 2012. Lorcaserin is a selective serotonin agonist that is approved as a weight loss agent. Lorcaserin is one of three prescription drugs poised to enter the u. Summary of patients randomized in lorcaserin phase 2 and phase 3 trials. Lorcaserin and phenterminetopiramate were approved by the fda in june 2012 and. Fda requested that the manufacturer of belviq lorcaserin. Methods in this doubleblind clinical trial, we randomly assigned 3182 obese or over.
Lorcaserin affects appetite signals in the brain, helping you feel full with smaller meals. Fda calls for withdrawal of weight loss drug belviq after. On thursday, an fda advisory committee is scheduled to meet to consider approval of the drug qnexa, and the federal agency is expected to decide on the application in october. Fda has requested that the manufacturer of belviq, belviq xr lorcaserin voluntarily withdraw the weightloss drug from the u. A drug safety communication from the us food and drug administration fda, in january 2020, stated that a clinical trial demonstrated a possible increased risk of cancer for those taking lorcaserin. In two pivotal clinical trials submitted to fda that excluded patients with diabetes, lorcaserin resulted in a mean percentage of body change in body weight of.
Lorcaserin is one of the last three drugs approved by the fda to treat adult people who are really suffering from excess fat. The drug activates serotonin receptors in the brain. This new drug application provides for the use of belviq as an adjunct to reduced calorie diet. Belviq is also approved for use by adults with a bmi of 27 or greater and who have at least one weightrelated condition such as high blood. Lorcaserin has been in clinical use for a short time only, but has not been linked to serum enzyme elevations during therapy or to instances of clinically apparent liver injury. The popular weight loss drug, called belviq, also called belviq xr lorcaserin, has been found to increase the risk of developing cancer, warns the u. Cardiovascular safety of lorcaserin in overweight or obese. Lorcaserin is a serotonin 5ht agonist, fda approved in 2012 for longterm up to 2 years management of obesity, taken as 10 mg tablets twice daily bid.
Phase iii trials have found that more than 35% of patients lost greater than 5% of their baseline weight. Obese americans have the possibility to buy a package containing 60 lorcaserin 10mg oral tablets. Fda has requested that the weightloss drug belviq, belviq xr be withdrawn from the u. Jan 16, 2020 the popular weight loss drug, called belviq, also called belviq xr lorcaserin, has been found to increase the risk of developing cancer, warns the u. Of equal concern is the finding that lorcaserin seems to be associated with an increased incidence of depression or 1. Following the results of a recent safety trial, the food and drug administration fda have issued a warning that the weight loss drug lorcaserin belviq may increase the risk of cancer.
Lorcaserin approved for weight loss the food and drug administration recently approved the first drug for weight loss in more than ten years. An fda belviq cancer warning alert, belviq, belviq xr lorcaserin. Do not start, stop, or change the dose of any drug without checking with your doctor. Eisais interpretation of the data from the camelliatimi 61 trial differs from that of the fda. The us food and drug administration is alerting physicians and the public that a clinical trial designed to assess the cardiovascular safety of the obesity drug lorcaserin belviq belviq xr. However, a weak correlation was observed between the lorcaserin exposure and the body weight in phase 3 trials figure 3. Unlike to the food and drug administration fda approved lorcaserin as an obesity treatment, european medicines agency ema believes that lorcaserin advantages do not exceed it potential risks. Although not all of these side effects may occur, if they do occur they may need medical attention. Serotonin is a neurotransmitter that triggers feelings of wellbeing such as satisfaction, gratification and being fully fed. Safety clinical trial shows possible increased risk of cancer with weightloss medicine belviq, belviq xr lorcaserin issued on january 14. But lorcaserin is far more selective than the drug. Lorcaserin intra venous cocaine effects full text view. Lorcaserin is a 5ht2cspecific agonist, unlike previous nonselective agonists, fenfluramine and dexfenflurame, which activated 5ht2b receptors causing valvulopathy 102.
Cardiovascular disease is the leading cause of death and complications in patients with type 2 diabetes. The original nda submission included two sets of studies which addressed the binding affinity and receptor activation kinetics for lorcaserin against the human 5ht2a, 2b, and 2c receptors. At the time of marketing approval from belviq, the fda required eisai to perform a longterm trial evaluating the cardiovascular effects associated with the use of the drug. Lorcaserin belviq for weight loss steps american family. Ibm micromedex along with its needed effects, a medicine may cause some unwanted effects. Quick take semaglutide and cardiovascular risks 01. The weight loss drug belviq is based on the active component called lorcaserin hydrochloride and is created and distributed by the arena pharmaceuticals. Fda requests the withdrawal of the weightloss drug belviq. Background lorcaserin is a selective serotonin 2c receptor agonist that could be useful in reducing body weight. Multicenter, placebocontrolled trial of lorcaserin for. Tell all of your health care providers that you take this medicine lorcaserin tablets.
This new drug application provides for the use of belviq as an adjunct to reducedcalorie diet. What are some things i need to know or do while i take lorcaserin tablets. The fda requested that the manufacturer of the serotonin receptor agonist lorcaserin voluntarily withdraw the weightloss drug from the u. The use of lorcaserin in the management of obesity. Eisai, the manufacturer, has submitted a request to voluntarily withdraw the drug. Lorcaserin must be used along with a reduced calorie diet and an exercise plan. Oneil pm1, smith sr, weissman nj, fidler mc, sanchez m, zhang j, raether b, anderson cm, shanahan wr.
The drug may be used in this setting in patients with a bmi of more than 30 kgm 2 or a bmi of more than 27 kgm 2 in the presence of 1 or more weightrelated comorbidities such as hypertension, dyslipidemia, or type 2 diabetes. Pooled phase 3 trials, lorcaserin 10 mg bid versus. A bmi chart for height in inches and weight in pounds is provided below. Lorcaserin belviq national drug monograph va pbm services. Serotonin receptor selectivity profile of lorcaserin background. This includes your doctors, nurses, pharmacists, and dentists. Buy lorcaserin buy lorcaserin diet pill online where.
Eisai is now suggesting a possible increased risk of cancer. Lorcaserin is a weight loss drug manufactured by arena pharmaceuticals from california. Obesity belviq lorcaserin is a serotonin 2c receptor agonist indicated for chronic weight management in adults who are obese, or overweight and who have at least one. In clinical trials of at least one year in duration, 8. Fda issues complete response letter for lorcaserin new drug. The camelliatimi 61 trial for lorcaserin was a randomized, doubleblind, placebocontrolled clinical trial to study approximately 12,000 men and women over five years with. In clinical trials of at least one year duration, the mean decrease in heart rate was 1.
Dec 15, 2014 lorcaserin belviq is a selective serotonin 2c agonist labeled for chronic weight management in adults who are obese body mass index bmi. Occurrence of belviq has expanded range of medical options for onethird of adult americans who suffer from obesity. The use of lorcaserin in patients with severe renal impairment or endstage renal failure is not recommended. Use with other agents that affect serotonin pathways. Lorcaserin was previously shown to be efficacious for weight loss, which led to approval by the fda for longterm weight management in obese or overweight patients who had at least one weight. Headache was the most common adverse event experienced by patients during all phase iii trials. This is an update to the fda drug safety communication. Belviq xr lorcaserin hydrochloride extendedrelease tablets. This is an important step for us toward the fda s approval of lorcaserin, said jack lief, arenas president and chief executive officer.
Do not give this medicine lorcaserin tablets to a child. While the complete response letter provides us with. The safety and efficacy of lorcaserin in the management of. Food and drug administration fda reports that safety data from a lorcaserin clinical trial shows a possible increased risk of cancer. Belviq pronounced bellveek works by controlling appetite. The safety and efficacy of lorcaserin were established during two phase iii clinical trials in patients without diabetes bloom and blossom and one phase iii clinical trial in patients with type 2 diabetes bloom. Lorcaserin will be marketed by arena pharmaceuticals as the brand name, belviq. Belviq lorcaserin, together with lowercalorie diet plan and regular exercise, can help achieve incredible results in terms of weight loss and health. Lorcaserin side effects, uses, dosage, overdose, pregnancy. Fda accepts resubmission of lorcaserin new drug application fda target action date set for june 27, 2012. Food and drug administration today issued a drug safety communication following a data analysis from a postmarket clinical trial of belviq and belviq xr lorcaserin shows that an. Placement of lorcaserin into schedule iv on december 19, 2012. Obesity drug belviq is heart safe in cardiovascular outcome study.
Belviq lorcaserin hydrochloride is a serotonin 2c receptor agonist indicated for the treatment of chronic weight management in adults with a body mass index of 30 or greater as an addition to a reducedcalorie diet and exercise. Semaglutide and cardiovascular outcomes in patients with. Lorcaserin is a novel and selective agonist of the 5ht. Fda is alerting the public that results from a clinical trial assessing safety show a possible increased risk of cancer with the weight management medicine belviq, belviq xr lorcaserin. Lorcaserin is sometimes used to treat obesity that may be related to diabetes, high cholesterol, or high blood pressure. Bmi is calculated by dividing weight in kg by height in meters squared. In 2016 the agency approved an extendedrelease, 20mg, oncedaily dosing option of lorcaserin belviq xr.