What are the 4 FDA-approved weight loss drugs?

A Review of FDA-Approved Medications for Chronic Weight Management Pharmacological Agents Approved for Chronic Weight Management. ... Semaglutide (Wegovy) ... Liraglutide (Saxenda) ... Naltrexone ER/Bupropion ER (Contrave) ... Phentermine/Topiramate ER (Qsymia)

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Obesity is a worldwide major public health concern. In the US, approximately 74% of adults are either overweight (BMI 25-29.9 kg/m2) or obese (BMI > 30 kg/m2).1 Obesity is associated with serious health complications including type 2 diabetes, hypertension, dyslipidemia, and cardiovascular disease.2 As such, obesity is considered a multi-faceted chronic disease that requires appropriate management. According to the American Association of Clinical Endocrinologists and the American College of Endocrinology, lifestyle modification, consisting of a reduced-calorie diet and physical activity, is the first-line management strategy for overweight and obesity.2 Pharmacotherapy is recommended as an adjunct to lifestyle modifications in patients with a BMI > 30 kg/m2 or in patients with a BMI > 27 kg/m2 in the presence of weight-related comorbidities, such as diabetes, hypertension, and dyslipidemia.2 The recent FDA approval of semaglutide for weight management presents an important advancement in the pharmacotherapy options available to the practitioner as well as to the patient. The aim of this article is to provide a brief overview of the agents that are FDA-approved for chronic weight management.

Pharmacological Agents Approved for Chronic Weight Management

Five medications are currently approved by the FDA for chronic weight management (see Table); these include semaglutide (Wegovy; Novo Nordisk), liraglutide (Saxenda; Novo Nordisk), naltrexone extended-release (ER)/bupropion ER (Contrave; Orexigen Therapeutics Inc), phentermine/topiramate ER (Qsymia; Vivus, Inc), and orlistat (Xenical and Alli).3 Notably, semaglutide, naltrexone ER/bupropion ER, and phentermine/topiramate ER are approved for adult use only, whereas liraglutide and orlistat are also approved for children aged 12 and older.3 None of the approved agents are recommended in pregnancy or in patients planning a pregnancy.3 An additional medication, setmelanotide (Imcivree; Rhythm Pharmaceuticals), is approved for the treatment of obesity caused by 3 rare genetic conditions and is not indicated for weight management in the general patient population.3,4 The choice of which medication to use in a given patient is influenced by patient comorbidities and patient preferences including the route of administration and dosing frequency, as well as cost. In addition to the aforementioned medications indicated for chronic weight management, several agents are approved for short-term (<12 weeks) use. Clinical guidelines, though, recommend weight loss medications to be used chronically for a sustained effect.2 When comparing the efficacy of weight-loss agents, it is important to note that even a sustained 5% weight loss has been shown to produce a clinically meaningful reduction in triglycerides, blood glucose, blood pressure, and the risk of developing type 2 diabetes.2

Semaglutide (Wegovy)

The most recently approved medication, semaglutide, is a glucagon-like peptide-1 (GLP-1) agonist that is also approved for use in type 2 diabetes. Compared with the other approved agents, semaglutide resulted in the greatest weight loss among patients who used it. Animal studies showed that semaglutide activates neurons in brain regions involved in the regulation of appetite, thus decreasing food intake. The recommended initial dose is 0.25 mg injected subcutaneously once weekly for 4 weeks with dose increments every 4 weeks to a maintenance dose of 2.4 mg once weekly. The rationale behind this titration is to decrease gastrointestinal adverse effects (AEs) that are associated with the GLP-1 agonist drug class. AEs reported with the use of semaglutide in clinical trials at the rate of > 5% and with frequencies greater than placebo included nausea (44%), diarrhea (30%), vomiting (24%), constipation (24%), abdominal pain (20%), headache (14%), fatigue (11%), dyspepsia (9%), dizziness (8%), abdominal distension (7%), eructation (7%), hypoglycemia in patients with type 2 diabetes (6%), flatulence (6%), gastroenteritis (6%), and gastroesophageal reflux disease (5%). Semaglutide carries a black box warning for thyroid C-cell tumors; a warning that is based on data from animal studies. Semaglutide is contraindicated in patients with a personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2. Additional warnings include acute kidney injury, mostly due to volume depletion, as well as acute pancreatitis, acute gallbladder disease, increase in heart rate, and suicidal ideation. Patients with type 2 diabetes, who use semaglutide for weight loss, are at an increased risk for hypoglycemia, especially if they are using insulin or an insulin secretagogue (eg, sulfonylurea), and for diabetic retinopathy complications.

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Pharmacists should advise the patient to stay hydrated, rotate injection sites with each injection, and use semaglutide on the same day each week. Patients should not use semaglutide with other GLP-1 agonists.5

Liraglutide (Saxenda)

Like semaglutide, liraglutide is a GLP-1 agonist with similar pharmacology and AE profile. Liraglutide is administered as a subcutaneous injection. The dose is initiated at 0.6 mg daily which is titrated in weekly intervals to a maintenance dose of 3 mg daily. AEs reported with the use of liraglutide in clinical trials at the rate of > 5% and with frequencies greater than placebo included nausea (39.3%), diarrhea (20.9%), constipation (19.4%), vomiting (15.7%), injection site reactions (13.9%), headache (13.6%), hypoglycemia in patients with type 2 diabetes (12.6%), dyspepsia (9.6%), fatigue (7.5%), dizziness (6.9%), abdominal pain (5.4%), increased lipase (5.3%), and upper abdominal pain (5.1%). Liraglutide carries a black box warning for thyroid C-cell tumors; a warning that is based on data from animal studies. Liraglutide is contraindicated in patients with a personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2, as well as in pregnancy. Additional warnings include acute pancreatitis, acute gallbladder disease, hypoglycemia, especially if used with insulin or an insulin secretagogue, increase in heart rate, renal impairment, mostly due to volume depletion, and suicidal ideation. Caution should be used when initiating liraglutide in patients with renal dysfunction or hepatic impairment. In addition to counseling on injection techniques and AEs, pharmacists should counsel patients to discontinue liraglutide if they have not achieved 4% weight loss from baseline by 16 weeks, as it is not likely that continued treatment would result in clinically meaningful weight loss. Patients should not use liraglutide with other GLP-1 agonists.6

Naltrexone ER/Bupropion ER (Contrave)

Naltrexone is an opioid antagonist which is also indicated for opioid use disorder, and bupropion is a dopamine and norepinephrine reuptake inhibitor which is also indicated for depression and smoking cessation. The 2 medications work synergistically by stimulating 2 areas of the brain involved with the regulation of food intake: the hypothalamus and the mesolimbic dopamine circuit. This medication is available as ER tablets containing 8 mg of naltrexone and 90 mg of bupropion. The recommended initial dose is 1 tablet once daily orally with weekly increments to a maintenance dose of 2 tablets in the morning and 2 tablets in the evening. AEs reported with the use of naltrexone ER/bupropion ER in clinical trials at the rate of > 5% and with frequencies greater than placebo included nausea (32.5%), constipation (19.2%), headache (17.6%), vomiting (10.7%), dizziness (9.9%), insomnia (9.2%), dry mouth (8.1%), and diarrhea (7.1%). Because bupropion is an antidepressant, naltrexone ER/bupropion ER carries a black box warning for an increased risk of suicidal thoughts and behaviors. Naltrexone ER/bupropion ER is contraindicated in patients with uncontrolled hypertension, chronic opioid use, seizure disorders, anorexia nervosa or bulimia, patients undergoing abrupt discontinuation of alcohol, benzodiazepines, barbiturates, or antiepileptic drugs, patients using other bupropion products, and patients who have taken monoamine oxidase inhibitors (MAOIs) within the last 14 days. Other precautions include neuropsychiatric events, which were reported in patients who used bupropion for smoking cessation, hepatotoxicity associated with naltrexone, activation of mania, increase in blood pressure and heart rate, angle-closure glaucoma, and hypoglycemia in patients with type 2 diabetes who are on insulin or an insulin secretagogue. This medication should also not be used in patients with end-stage renal disease or severe hepatic impairment. Pharmacists should counsel patients to avoid taking this medication with a high-fat meal, since doing so increases systemic exposure to the medication, and to avoid drinking alcohol. If after 12 weeks at the maintenance dose, the patient does not achieve at least 5% weight loss from baseline, naltrexone ER/ bupropion ER should be discontinued.7

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Phentermine/Topiramate ER (Qsymia)

Phentermine’s mechanism in weight loss is believed to involve the release of catecholamines in the hypothalamus, leading to decreased appetite and food intake. It is also available as monotherapy for short-term weight management.2 Topiramate produces weight loss by suppressing appetite and enhancing satiety, which is achieved by several possible pharmacological mechanisms. Phentermine/topiramate ER is taken orally once daily in the morning to avoid insomnia. The initial dose is 3.75 mg/23 mg daily and titrated up to 7.5 mg/46 mg daily after 14 days. After 12 weeks on the latter dose, the patient’s weight loss is evaluated and if the patient does not achieve at least 3% weight loss from baseline, the medication may be discontinued as continued use on this dose is not likely to produce clinically meaningful weight loss. Alternatively, at that point, the dose may be increased to 11.25 mg/69 mg daily for 14 days followed by 15 mg/92 mg daily, which is the maximum recommended dose. If the patient does not achieve at least 5% weight loss from baseline after 12 weeks on the maximum dose, the medication should be discontinued. AEs reported with the use of phentermine/topiramate ER in clinical trials at the rate of > 5% and with frequencies greater than placebo included paresthesia (19.9%), dry mouth (19.1%), constipation (16.1%), upper respiratory tract infection (13.5%), headache (10.6%), dysgeusia (9.4%), insomnia (9.4%), nasopharyngitis (9.4%), dizziness (8.6%), sinusitis (7.8%), nausea (7.2%), back pain (6.6%), fatigue (5.9%), diarrhea (5.6%), blurred vision (5.4%), bronchitis (5.4%), and urinary tract infection (5.2%). Because it contains phentermine, an amphetamine-like stimulant, this medication is classified as a schedule IV controlled substance. Phentermine/topiramate ER is contraindicated in pregnancy, glaucoma, hyperthyroidism, and within 14 days of MAOI use. Due to teratogenic risk, this medication is available through a Risk Mitigation and Evaluation Strategy (REMS) program. Warnings associated with the use of the medication include an increase in heart rate, suicidal ideation, acute myopia and secondary angle closure glaucoma, cognitive impairment, mood and sleep disorders, metabolic acidosis, elevation in creatinine, kidney stones, oligohidrosis and hyperthermia, and hypokalemia. Patients should have their laboratory chemistry profiles analyzed periodically throughout the treatment.

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