Which of the following medications is currently approved by fda for weight loss?
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The drug, semaglutide, "induces weight loss by reducing hunger, increasing feelings of fullness, and thereby helping people eat less and reduce their calorie intake," according to a company statement. Show
Novo Nordisk plans to launch the drug, given the brand name Wegovy, later this month in the United States. The weight loss drug is currently under review by the European Medicines Agency. Several experts said they this drug has the potential to seriously change care of patients when it comes to weight loss. Drug Tested in Clinical TrialThe favorable FDA ruling is based on results from four phase III clinical trials that tested the drug's safety and efficacy in more than 4,500 adults with overweight or obesity. The trial participants received either a reduced calorie meal plan and increased physical activity or the lifestyle intervention plus semaglutide. The results were published in the New England Journal of Medicine, The Lancet , and JAMA in February and March 2021. In the three of the four trials of individuals with overweight and obesity, those in the semaglutide groups saw 15% to 18% weight loss over 68 weeks. The dosage was well-tolerated. The most common side effects were gastrointestinal, and they were brief and mild or moderate in severity. A coauthor of the first trial, Rachel Batterham, PhD, of the Centre for Obesity Research at University College London, said at the time of publication: "The findings of this study represent a major breakthrough for improving the health of people with obesity." "No other drug has come close to producing this level of weight loss — this really is a game changer. For the first time, people can achieve through drugs what was only possible through weight-loss surgery," she added. Welcome Addition, But Will Insurance Cover It?Invited to comment on the FDA approval, Thomas A. Wadden, PhD, from the Perelman School of Medicine at the University of Pennsylvania, and lead author of third trial , said in an email that "semaglutide … appears to be the breakthrough in weight management that health care providers and their patients with obesity have been waiting for." There are concerns regarding insurance coverage and pricing, Wadden said, potentially blocking use of the drug. "I hope that the millions of people — in the U.S. and worldwide — who could benefit from this medication eventually will have access to it," said Wadden. "In the U.S., the coverage of anti-obesity medications by insurers and employers will need to improve to ensure this happens, and the medication must be reasonably priced. These changes are critical to making this medication the game changer it could be." "This approval is an important development," Scott Kahan, MD, director of the National Center for Weight and Wellness in , Washington, D.C., who was not involved in clinical trials of the drug, said similarly told Medscape Medical News in an email. "In a field with relatively few medication options, the availability of additional obesity pharmacotherapy agents is welcome," he said. "In particular, semaglutide has shown impressive efficacy and safety data; as such it should be a valuable clinical option for many patients." Though the drug could be a viable option for many patients, access to obesity treatments has traditionally been a challenge, Kahan warned. "Novo Nordisk's other obesity medication, Saxenda, has been a valuable tool, but one that exceedingly few patients are able to utilize due to minimal insurance reimbursement and very high cost," he said.However, it is concerning that "access to obesity treatments has traditionally been a challenge," Kahan warned. "Novo Nordisk's other obesity medication, Saxenda, has been a valuable tool, but one that exceedingly few patients are able to utilize due to minimal insurance reimbursement and very high cost." "It remains to be seen how accessible semaglutide will be for patients," according to Kahan. "Still, if the challenge of limited coverage and high cost can be mitigated, this medication has a chance to significantly change the current paradigm of care, which until now has included minimal use of pharmacotherapy outside specialty clinics," he maintained. Semaglutide (Wegovy) is the first once-weekly medication in its class that’s FDA-approved to help with chronic weight management. It works best when used in combination with a healthy diet and exercise. The largest clinical trial showed that people taking semaglutide lost an average of almost 15% of their initial body weight — about 12% more than those who didn’t take the medication. There are many ways to save on Wegovy, the version of semaglutide approved for weight loss. If you’re eligible, a manufacturer savings card can help you access Wegovy for as little as $25. In June 2021, the FDA approved semaglutide (Wegovy), a once-weekly injection, for chronic weight management when used in combination with a healthy diet and exercise. The medication had made headlines before its approval when the manufacturer reported 15% to 18% weight loss findings during clinical trials. This is higher than we tend to see with other weight loss medications. So, is semaglutide right for you? While it may work better than some other weight loss medications, What is semaglutide?Semaglutide is an injectable glucagon-like peptide-1 (GLP-1) agonist that’s administered once weekly. It was originally approved in 2017 — at a lower dose under the brand name Ozempic — to help control blood sugar in Type 2 diabetes. People taking Ozempic for blood sugar control also tend to lose weight as an additional benefit. Because of this, Novo Nordisk studied the medication in people without Type 2 diabetes, but at a higher dose. Now, semaglutide (under the brand name Wegovy) is FDA-approved for weight loss. It can be used by adults with a body mass index (BMI) greater than or equal to 30 mg/kg² alone or 27 mg/kg² with at least one weight-related condition (e.g., high blood pressure, high cholesterol, Type 2 diabetes). Semaglutide should be used in combination with lifestyle changes, including a healthy diet and exercise. How does semaglutide work for weight loss?GLP-1 is an incretin hormone that plays a role in your appetite and digestion. Incretins — hormones released by your digestive tract — are sent out by your body after you’ve eaten a meal. They help lower your blood sugar by triggering insulin release and blocking sugar production. They also slow down how quickly food leaves your stomach (called gastric emptying). The result of these actions causes you to feel full — lowering your appetite and causing you to lose weight. Medications like GLP-1 agonists are referred to as incretin mimetics since they “mimic” these effects. As mentioned above, GLP-1 agonists, like semaglutide, were originally used to treat Type 2 diabetes. This was due to their blood sugar-lowering effects. However, the weight loss side effect has been shown to benefit people without Type 2 diabetes as well. How is semaglutide dosed?Semaglutide is available as a single-use injection pen. This means that your dose is already pre-set for you, and that you’ll discard the pen after your dose. You’ll give yourself the injection once a week, on the same day each week. It can be given at any time of day, and you can take it with or without food. Semaglutide is typically injected just under the skin (subcutaneously) in your abdomen, upper arm, or thigh. Avoid injecting the medication into the same spot every time — change your injection site with each dose. But injecting in the same body area (e.g., thigh) is OK as long as you’re rotating sites within the area each time. Since semaglutide slows down how quickly food leaves your stomach, you may experience side effects like nausea and vomiting. Once you get started on the medication, your healthcare provider will slowly increase your dosage every 4 weeks. This can help make these effects more manageable. The target dose is 2.4 mg once weekly. Before reaching the target dose, a typical dosing schedule may look like:
Some people may not be able to reach or tolerate the target dose due to side effects. If this is the case, your healthcare provider may wait another month before increasing your dose. However, they may have you stop the medication if you’re unable to reach or stay on the target dose. What do we know about semaglutide side effects?As introduced earlier, gastrointestinal (GI) side effects tend to happen most frequently when taking this medication. The most common are nausea, diarrhea, and vomiting. You may experience these effects more strongly when your healthcare provider increases your dose. Additional common side effects can include:
Serious side effectsIn some cases, semaglutide may cause more serious side effects. The medication has a boxed warning — the FDA’s most serious warning — for a potential risk for thyroid C-cell tumors. This risk has been seen in animal studies, but it hasn’t been confirmed in people. Because of this, you shouldn’t take semaglutide if you have a personal or family history of certain thyroid tumors. Other serious side effects can include:
Suicidal thoughts and behaviors are another risk listed on the medication’s labeling because it’s been reported with other weight loss medications. Let your healthcare provider know right away if you’re experiencing any changes in mood or behavior, or if you’re having suicidal thoughts. Can semaglutide interact with other medications?Since semaglutide can lower your blood sugar, it can interact with other blood sugar-lowering medications. Examples include insulin and medications that cause insulin to be released, like sulfonylureas. Combining these medications can result in dangerously low blood sugar levels. If you’re taking one of these medications, your healthcare provider may lower the other medication’s dose while starting you on semaglutide. And as a general rule, it’s important to diligently monitor your blood sugar if you have Type 2 diabetes. This is especially the case before and during treatment to ensure that your readings stay within a safe range. Another potential interaction is with oral medications. Semaglutide slows down how quickly food leaves your stomach. This may affect how certain oral medications are absorbed by your body when they’re taken together. Your healthcare provider can determine which interactions potentially affect you and how to manage them How does semaglutide compare to other weight loss medications?One of the reasons there’s a lot of buzz around semaglutide is the amount of weight people lost during clinical trials. Typically, we tend to see an average of 5% to 10% weight loss with other medications. Oral weight loss medications tend to be less expensive than the injectable options, but you may not lose as much weight. Let’s review a few of the more popular weight loss medications and how they compare to semaglutide. Oral medicationsPhentermine is a popular oral weight loss medication that has been around since 1959. It’s approved for short-term use (a few weeks), and it’s inexpensive. However, it’s possible to develop a tolerance to the medication where it’s no longer working for you. And it’s a controlled substance. Phentermine is also available in combination with topiramate under the brand name Qsymia. Compared to phentermine alone, Qsymia can be used for a longer period of time. Study results have shown average weight loss ranging from about 5% (at lower doses) to around 10% (at higher doses). Contrave (bupropion/naltrexone) is another medication used for weight loss. One study showed that people taking Contrave in combination with diet and exercise lost an average of about 9% of their baseline body weight after 56 weeks. This is compared to the largest semaglutide trial, where participants receiving the medication lost an average of almost 15% of their baseline body weight after 68 weeks. Injectable medicationsLiraglutide (Saxenda), a once-daily injectable GLP-1 agonist, was the first medication in its class to be approved for weight loss. It’s short-acting, which is why you need to administer it every day. It has also been shown to provide an average weight loss of about 8% from baseline body weight. Semaglutide, on the other hand, works longer in your body. So, it’s only given once a week. This makes semaglutide the first once-weekly GLP-1 agonist approved for weight loss — with better results. However, Saxenda is also approved for use in children at least 12 years old. Semaglutide is only approved for use in adults (people at least 18 years old). Medications being studied for weight lossTirzepatide (Mounjaro) is a new medication that was approved in May 2022 for Type 2 diabetes. Like semaglutide, it mimics GLP-1. But it also mimics another incretin called glucose-dependent insulinotropic polypeptide (GIP). While tirzepatide has similar effects as semaglutide, it’s the first medication in its class. Tirzepatide was compared to semaglutide in a head-to-head clinical trial in people with Type 2 diabetes. It was more effective for long-term blood sugar control, and people taking it lost more weight compared to semaglutide. While tirzepatide isn’t currently approved for weight loss, promising results from a phase 3 trial for this use were published in July 2022. It’s possible that we’ll see tirzepatide approved for weight loss in the future. How to save on semaglutideThere are ways to save on semaglutide, which is available as brand-name Wegovy. For example, a copay savings card can help make your prescription more affordable. If you have commercial insurance, you may be eligible to pay as little as $25 for Wegovy using a savings card from the manufacturer. The bottom lineSemaglutide is an FDA-approved injectable weight loss medication. Compared to other medications on the market, it may help you lose more weight. It takes a few months to reach the target dose, and you may experience side effects like nausea, vomiting, and diarrhea. But this is typically managed by slowly increasing your dose over time. Talk to your healthcare provider to learn more about semaglutide for weight loss. They can recommend the best chronic weight management option for you. ReferencesA-S Medication Solutions. (2021). Wegovy [package insert]. Frías, J. P., et al. (2021). Tirzepatide versus semaglutide once weekly in patients with type 2 diabetes. New England Journal of Medicine. GoodRx Health has strict sourcing policies and relies on primary sources such as medical organizations, governmental agencies, academic institutions, and peer-reviewed scientific journals. Learn more about how we ensure our content is accurate, thorough, and unbiased by reading our editorial guidelines. Was this page helpful?thumb_up_outlinedthumb_down_outlined Best Foods For A Healthy Weight!Sign up for our GoodRx Diet and Nutrition Newsletter to receive the latest healthy eating advice, recipes, and savings that are most relevant to you.By signing up, I agree to GoodRx's Terms and Privacy Policy, and to receive marketing messages from GoodRx. What are the FDA approved drugs for weight loss?Six weight-loss drugs have been approved by the U.S. Food and Drug Administration (FDA) for long-term use:. Bupropion-naltrexone (Contrave). Liraglutide (Saxenda). Orlistat (Xenical, Alli). Phentermine-topiramate (Qsymia). Semaglutide (Wegovy). Setmelanotide (Imcivree). What is the new weight loss drug that has been approved?Wegovy, which is a higher dose of the self-injectable diabetes drug Ozempic, helped patients lose an average of 15% of their body weight over 68 weeks during the clinical trial that led to its FDA approval last year.
Is Saxenda is FDA approved for weight loss?Saxenda is a medication that's FDA-approved for chronic weight management. It works best when it's used in combination with a reduced-calorie diet and physical activity. Saxenda is approved for use in adults with a body mass index (BMI) of 30 kg/m2 or higher.
What is the best diet pill approved by the FDA?7 FDA-approved weight-loss pills. Lomaira, Adipex (phentermine) Phentermine is the most commonly prescribed weight-loss medication used in this country. ... . Qsymia (phentermine/topiramate) ... . Saxenda (liraglutide) ... . Contrave (naltrexone and bupropion) ... . Plenity. ... . Xenical, Alli (orlistat) ... . Wegovy (semaglutide). |
