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FDA Approves Wegovy (Semaglutide) for Obesity in Teens 12 and Up Login/Join 
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Lots of money for Big Pharma if insurance will pay for it. Very concerning in my opinion. Do not see any screening required for bulimia or body dysmorphic disorder. Here it is:

The US Food and Drug Administration has approved semaglutide 2.4 mg (Wegovy), a once-weekly subcutaneous injection, for the additional indication of treating obesity in adolescents aged 12 years and older.

This is defined as those with an initial BMI at or above the 95th percentile for age and sex (based on CDC growth charts). Semaglutide must be administered along with lifestyle intervention of a reduced calorie meal plan and increased physical activity.

When Wegovy was approved for use in adults with obesity in June 2021, it was labeled a "game changer."

The new approval is based on the results of the STEP TEENS phase 3 trial of once-weekly 2.4 mg of semaglutide in adolescents 12- to <18 years old with obesity, the drug's manufacturer, Novo Nordisk, announced in a press release.

In STEP TEENS, reported at Obesity Week 2022 in November, and simultaneously published in the New England Journal of Medicine, adolescents with obesity treated with semaglutide for 68 weeks had a 16.1% reduction in BMI compared with a 0.6% increase in BMI in those receiving placebo. Both groups also received lifestyle intervention. Mean weight loss was 15.3 kg (33.7 lb) among teens on semaglutide, while those on placebo gained 2.4 kg (5.3 lb).

At the time, Claudia K. Fox, MD, MPH, co-director of the Center for Pediatric Obesity Medicine at the University of Minnesota Medical School — who was not involved with the research — told Medscape the results were "mind-blowing…we are getting close to bariatric surgery results" in these adolescent patients with obesity.

Semaglutide is a GLP-1 agonist, as is a related agent, also from Novo Nordisk, liraglutide (Saxenda), a daily subcutaneous injection, which was approved for use in adolescents aged 12 and older in December 2020. Wegovy is the first weekly subcutaneous injection approved for use in adolescents.

Other agents approved for obesity in those older than 12 in the US include the combination phentermine and topiramate extended-release capsules (Qsymia) in June 2022, and orlistat (Alli). Phentermine is approved for those aged 16 and older.

LINK: https://www.medscape.com/viewa...5325SY&impID=5064387
 
Posts: 17698 | Location: Stuck at home | Registered: January 02, 2015Reply With QuoteReport This Post
Wait, what?
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So instead of getting teens out and taking part of an active lifestyle to get in shape, let’s just solve it with drugs. Wonderful.




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Posts: 15985 | Location: Martinsburg WV | Registered: April 02, 2011Reply With QuoteReport This Post
paradox in a box
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So if they take the drug and eat less and exercise they will lose weight. Shit I could have invented that drug.




These go to eleven.
 
Posts: 12605 | Location: Westminster, MA | Registered: November 14, 2006Reply With QuoteReport This Post
Eye on the
Silver Lining
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Holy shit. This is not good.


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Posts: 5569 | Registered: October 24, 2005Reply With QuoteReport This Post
Spread the Disease
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Why is obesity in children (without a valid medical reason) NOT considered child abuse?

And yes, I have 2 kids. Neither is obese.


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Posts: 17746 | Location: New Mexico | Registered: October 14, 2005Reply With QuoteReport This Post
Knows too little
about too much
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FDA approval of ANY DRUG is no cause for comfort or confidence.

They're just as twisted and screwed up as the CDC and NHS.

Wonder if they agree to hide the outcome data for 75 years?

RMD




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Posts: 20425 | Location: L.A. - Lower Alabama | Registered: April 06, 2008Reply With QuoteReport This Post
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