Fda Approved Weight Loss Over The Counter – The Food and Drug Administration said this new version of a popular diabetes drug could be sold as a weight-loss drug in the US (Novo Nordisk via AP)

The Food and Drug Administration has approved Wegovy, a high-dose version of Novo Nordisk’s diabetes drug semaglutide, for long-term weight and obesity management.

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In studies funded by the company, participants taking Wegovy had an average loss of 15%, about 34 pounds. The participants lost weight slowly for 14 months before climbing. In the comparison group getting dummy shots, the average weight loss was about 2.5%, or just under 6 pounds.

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“With the existing drugs, you will get maybe 5% to 10% weight loss, sometimes not even,” said Dr. Harold Bays, medical director of the Louisville Metabolic and Atherosclerosis Research Center. Bays, who is also the Obesity Medicine Association’s chief scientific officer, helped conduct studies of the drug.

Losing even 5% of a person’s weight can bring health benefits, such as improved energy, increased blood pressure, blood sugar and cholesterol levels, but that much often does not satisfy patients who are focused on losing weight, Bays said.

Bays said Wegovy appears to be safer than obesity drugs that have “come under fire” because of safety issues. Wegovy’s most common side effects were gastrointestinal problems, including nausea, diarrhea and vomiting. Those tended to decline, but they led about 5% of study participants to stop taking it.

This medicine carries the risk of a type of thyroid tumor, so it should not be taken by people with a personal or family history of other thyroid and endocrine tumors. Wegovy also has a risk of depression and pancreas inflammation.

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Wegovy (pronounced wee-GOH’-vee) is a compounded version of a hormone in the stomach that regulates appetite. Patients inject it weekly under their skin. Like other weight loss drugs, it should be used in conjunction with exercise, a healthy diet and other measures such as keeping a food diary.

The Danish company has not disclosed the price of Wegovy but said it will be similar to the price of Saxenda, a daily injectable weight loss drug that now costs more than $1,300 a month without insurance.

Dr. Archana Sadhu, director of the diabetes program at Houston Methodist Hospital, said Wegovy’s usefulness “all depends on what the cost will be.” He noted health insurance plans sometimes don’t cover weight-loss treatments, putting expensive medications away.

Sadhu, who is not affiliated with Novo Nordisk, plans to switch obese and type 2 diabetic patients to Wegovy. It makes patients feel full faster and increases the release of insulin from the pancreas to control blood sugar, he said. Patients would have the opportunity to be encouraged to exercise and eat healthy, he added.

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Wegovy builds on the process by which developers of new diabetes drugs test them to treat other conditions common to people with diabetes. For example, the popular diabetes drugs Jardiance and Novo Nordisk’s Victoza are now approved to reduce the risk of heart attack, stroke and death in heart patients.

Phylander Pannell, 49, of Largo, Maryland, joined the patient study after losing a relapse. He said he received Wegovy, worked out several times a week and lost 65 pounds in 16 months.

“It helped me reduce my appetite and helped me feel full faster,” said Pannell. “It set me on the right path.”

Shortly after he graduated and stopped taking Wegovy, he regained half the weight. After losing most of that, she started exercise classes and bought home appliances. He is considering returning to Wegovy after it is approved.

U.s. Experts Recommend Weight Loss Drugs For Obese Children

The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is responsible for all content.

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Jan 9 () – The American Academy of Pediatrics (AAP) on Monday recommended the use of weight loss drugs in children aged 12 years or older for the treatment of obesity, which affects 14 million children and adolescents in the United States and can lead to serious health problems.

The new guidelines – the first in a decade – focus on treating obesity, as opposed to preventing it.

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“I think they are important because there is a lot of misunderstanding about the real cause of obesity and there are some things that are not considered, even by medical doctors regarding childhood obesity,” said Dr. Marc Michalsky of Nationwide Children’s Hospital in Columbus, Ohio. another instructional writer.

The expert group said that treatments such as the weight-loss pill orlistat, Novo Nordisk’s ( NOVOb.CO ) semaglutide – a diabetes injection brought back to reduce weight under the brand name Wegovy – and the older, generic diabetes drug metformin could be given in addition to. changes in health and lifestyle.

Metformin has been used for weight loss in children. Among the 27 randomized trials of metformin for weight loss in children reviewed by a leading panel, 74% showed some positive effects of the drug.

“In particular, children with acute and life-threatening infections, the elderly, and those with severe obesity may require additional treatment options,” the group said.

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The threshold for childhood obesity is body mass index (BMI) – the ratio of weight to height – above 95 percent for children of the same age and gender. Severe obesity is defined as a BMI 20% higher than the 95th percentile cutoff.

GlaxoSmithKline’s (GSK.L) orlistat is approved by the U.S. Food and Drug Administration for the treatment of chronic obesity in children 12 years of age and older. The appetite suppressant phentermine is approved for ages 16 and up.

Wegovy last month won US approval for weight loss in children 12 years and older. The FDA has also approved the diabetes drug Saxenda (liraglutide) from Novo Nordisk as a treatment for obesity in adolescents aged 12 years and older.

The FDA also approved an additional indication for Qsymia (phentermine and topiramate extended-release capsules) from Vivus for chronic weight management in obese patients 12 years of age and older.

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The steering committee found that many of the trials it reviewed did not include children with mental health problems, physical disabilities, or the use of certain medications.

“In clinical practice, these children often have a greater need for support in managing obesity,” the authors said.

For children ages 2 to 12, the AAP said there was currently not enough evidence to recommend the use of these drugs.

It includes recommendations for annual obesity screening in children aged 6 and over, through BMI monitoring, and practices such as motivational counseling.

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Metabolic and bariatric surgery is also recommended as a group treatment for adolescents with severe obesity.

Intensive counseling of children and parents about health behaviors and lifestyles over a period of 3 to 12 months is an effective method for treating childhood obesity, but “is difficult to deliver and not universally available,” the AAP said.

Bhanvi Satija reports on pharmaceutical companies and the healthcare industry in the United States. He holds a graduate degree in International Journalism from the City, University of London. Boxes of the diabetes drug Ozempic rest at a pharmacy on April 17, 2023 in Los Angeles, California.

U.S. The Food and Drug Administration is warning consumers not to use off-brand versions of the popular weight loss medications Ozempic and Wegovy because they may not contain the same active ingredients and may not be as safe or effective.

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Officials of the organization said this week that they received reports of problems after patients used versions of maglutide, which is active in the name of the drug, which is mixed, or mixed in pharmacies. Officials did not say what the problems were.

The problem is that the versions, usually sold online, contain a version of semaglutide that is used in lab research and has not been approved for use in humans.

“Combined drugs have not been approved by the FDA, and the agency does not vouch for the safety or efficacy of combined drugs,” the announcement said.

Sales of semaglutide products have risen in the past few years after the drug was shown to be fast and effective in weight loss. Medicines manufactured by Novo Nordisk include the brands Ozempic and Rybelsus, used to treat diabetes, and Wegovy, approved to treat obesity.

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The demand for drugs has outstripped supply. As of May, Ozempic and Wegovy remain on the FDA’s drug shortage list. If medicines are in short supply, the participating pharmacies are allowed to make those kinds of medicines.

Consumers should only use drugs containing semaglutide with a prescription from an authorized health care provider and obtained from a government pharmacy or other facilities registered with the FDA, the agency said.

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