![]() Belviq: 5 Things You Need to Know About the New Weight- Loss Drug. FDA / APThis photo provided by Food and Drug Administration shows Arena Pharmaceutical's anti- obesity pill Belviq. The first new prescription diet drug in 1. Food and Drug Administration (FDA) approval on Wednesday, offering a new alternative to aid weight loss for the nearly one in three Americans who are considered obese. The new drug, called Belviq (lorcaserin), is made by Arena Pharmaceuticals. Here’s what you need to know: How does Belviq work? ![]() ![]() ![]() The drug works by controlling appetite — specifically by activating brain receptors for serotonin, a neurotransmitter that triggers feelings of satiety and satisfaction. Serotonin is also involved in mood; many antidepressant drugs work by preventing the reuptake of serotonin and keeping brain receptors bathed in the chemical. Researchers at Arena say their drug is designed to seek out only the serotonin receptors that affect appetite. How effective is it? According to clinical trial data submitted by Arena to the FDA, nearly half of dieters without Type 2 diabetes who used the medication lost at least 5% of their starting weight — or an average of 1. For best results, dieters are advised to use the medication together with a healthy diet and exercise program. The approved labeling for Belviq also recommends that people discontinue the drug if they fail to lose 5% of their body weight after 1. MORE: Calorie vs. Calorie: Study Evaluates Three Diets for Staying Slim)Who can take Belviq? The FDA approved the medication for people who are obese (with a body mass index, or BMI, of 3. BMI of 2. 7 or above) and also have at least one weight- related health condition such as Type 2 diabetes, high blood pressure or high cholesterol. Are there any side effects? The most common side effects of Belviq in non- diabetic patients are headache, dizziness, fatigue, nausea, dry mouth and constipation; in patients with diabetes, side effects include low blood sugar, headache, back pain, cough and fatigue. There was also some concern that Belviq caused tumors in animals and heart- valve defects in people. A similar serotonin- based drug that had been approved for weight loss — fenfluramine — was removed from the market in 1. ![]() ![]() Http:// Visit our Obesity / Weight Loss / Fitness category page for the latest news on this subject. ![]() Learn about Belviq (Lorcaserin Hydrochloride) may treat, uses, dosage, side effects, drug interactions, warnings, patient labeling, reviews, and related medications.
In 2. 01. 0, the FDA rejected Arena’s first request for approval, asking for more evidence of its safety. New data provided by the company showed that heart problems would not occur at the low doses at which Belviq would be prescribed. The FDA won’t require patients taking Belviq to be monitored for heart- valve damage, but the company is required to conduct six studies once the drug reaches the market to determine whether it causes heart attacks or stroke in people who take it.(MORE: A Brief History of Diet Pills and the FDA)Why did it take so long to get a new weight- loss drug approved? The history of diet pills has been plagued by safety problems. Since 1. 99. 9, when the last prescription weight- loss medication, Xenical (orlistat), was given the green light, one weight loss drug, Meridia (sibutramine) was taken off the market when users began showing increased risk of heart problems, and two others, Belviq and Qnexa, were rejected by the FDA over safety concerns. Manipulating the body’s weight- controlling pathways can have long- term consequences on the heart and other metabolic systems, so drug developers have a high bar to clear to prove their compounds are safe. Read the FDA’s announcement on Belviq here. Alice Park is a writer at TIME. Find her on Twitter at @aliceparkny. You can also continue the discussion on TIME’s Facebook page and on Twitter at @TIME. Belviq: Uses, Dosage, Side Effects & Warnings. Generic Name: lorcaserin (lor KAS er in)Brand Names: Belviq, Belviq XRWhat is Belviq? Belviq (lorcaserin) affects chemical signals in the brain that control appetite. Lorcaserin works by helping you feel full with smaller meals. Belviq is used together with diet and exercise to treat obesity. Belviq is sometimes used to treat obesity that may be related to diabetes, high cholesterol, or high blood pressure. Belviq will not treat any underlying health condition (such as heart disease, diabetes, high blood pressure). Keep taking any other medications your doctor has prescribed to treat these conditions. Important information. Do not use Belviq if you are pregnant. Weight loss during pregnancy can harm an unborn baby, even if you are overweight. Serious drug interactions can occur when certain medicines are used together with lorcaserin. Tell each of your healthcare providers about all medicines you use now, and any medicine you start or stop using. Before you take Belviq, tell your doctor if you have diabetes, congestive heart failure, a heart valve disorder, sickle cell anemia, leukemia or myeloma, kidney or liver disease, or a physical deformity of the penis (such as Peyronie's disease). Belviq may be habit- forming and should be used only by the person for whom it was prescribed. Keep the medication in a secure place where others cannot get to it. Tell your doctor if you do not lose at least 5% of your starting weight after taking the medication for 1. Belviq is only part of a complete program of treatment that also includes diet, exercise, weight control, and possibly testing your blood sugar. Before taking this medicine. You should not use Belviq if you are allergic to lorcaserin. Do not use lorcaserin if you are pregnant. Weight loss during pregnancy can harm an unborn baby, even if you are overweight. Tell your doctor right away if you become pregnant during treatment. To make sure lorcaserin is safe for you, tell your doctor if you have: diabetes; congestive heart failure; a heart valve disorder; a heart condition such as . You should not breast- feed while using this medicine. Belviq is not approved for use by anyone younger than 1. How should I take Belviq? Take Belviq exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended. The regular tablet is usually taken 2 times per day. The extended- release tablet is taken only once per day. Follow your doctor's instructions. Do not crush, chew, or break an extended- release tablet. Swallow it whole. You may take Belviq with or without food. You should lose at least 5% of your starting weight during the first 1. Belviq and eating a low calorie diet. Call your doctor if you do not lose at least 5% of your starting weight after taking the medicine for 1. Belviq is only part of a complete program of treatment that also includes diet, exercise, weight control, and possibly testing your blood sugar. Follow your diet, medication, and exercise routines very closely. Store at room temperature away from moisture and heat. Keep track of the amount of medicine used from each new bottle. Lorcaserin is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription. Do not share Belviq with another person. Keep the medication in a place where others cannot get to it. Belviq dosing information. Usual Adult Dose for Weight Loss: 1. Comments: Response to therapy should be evaluated by week 1. If a patient has not lost at least 5% of baseline body weight, discontinue this drug as it is unlikely the patient will achieve and sustain clinically meaningful weight loss with continued treatment. Use: Adjunct to a reduced- calorie diet and increased physical activity for chronic weight management in patients with an initial body mass index (BMI) of 3. OR 2. 7 kg/m. 2 or greater (overweight) in the presence of at least one weight- related comorbidity such as hypertension, type 2 diabetes mellitus, or dyslipidemia. See also: Dosage Information (in more detail)What happens if I miss a dose? Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose. What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1- 8. What should I avoid while taking Belviq? Belviq may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Do not take any other prescription or over- the- counter weight- loss products without your doctor's advice. Avoid taking cough and cold or allergy medications while taking this medicine. Belviq side effects. Get emergency medical help if you have signs of an allergic reaction to Belviq: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Stop using Belviq and call your doctor at once if you have: unusual changes in mood or behavior, thoughts of suicide or hurting yourself; feelings of standing next to yourself or being outside of your body; memory problems, trouble concentrating; breast swelling (in women or men), nipple discharge; penis erection that is painful or lasts longer than 4 hours; heart problems- -fast heart rate, trouble breathing, dizziness, ongoing weakness, or swelling in your arms, hands, legs, or feet; high levels of serotonin in the body- -agitation, hallucinations, fever, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, fainting; orsevere nervous system reaction- -very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out. Common Belviq side effects may include: headache, dizziness, feeling tired; dry mouth, cough; nausea, constipation; back pain; orlow blood sugar (in people with diabetes). This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1- 8. FDA- 1. 08. 8. See also: Side effects (in more detail)What other drugs will affect Belviq? Tell your doctor about all your current medicines and any you start or stop using, especially: cabergoline; linezolid; lithium; St. John's wort; tramadol; tryptophan (also called L- tryptophan); any type of antidepressant; cold or cough medicine that contains dextromethorphan (a cough suppressant); erectile dysfunction medicine- -avanafil, sildenafil, tadalafil, Cialis, Levitra, Viagra, and others; medicine to treat mental illness, anxiety, or a mood disorder; ora . Other drugs may interact with lorcaserin, including prescription and over- the- counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide. More about Belviq (lorcaserin)Consumer resources. Other brands: Belviq XRProfessional resources. Related treatment guides. Where can I get more information? Your pharmacist can provide more information about Belviq. Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Belviq only for the indication prescribed. Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist. Copyright 1. 99. 6- 2. Cerner Multum, Inc. Version: 2. 0. 1. Date modified: November 0. Last reviewed: October 2.
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