Dear Colleagues!  This is Asrar Qureshi’s Blog Post #868 for Pharma Veterans. Pharma Veterans aims to share knowledge and wisdom from Veterans for the benefit of Community at large. Pharma Veterans Blog is published by Asrar Qureshi on WordPress, the top blog site. Please email to asrar@asrarqureshi.com for publishing your contributions here.

The Medicine and the Medical Information

Ozempic® is a drug for Type 2 diabetes. It contains active ingredient Semaglutide. It is in the form of injection which should be given once weekly under the skin. Ozempic was approved in December 2017. Semaglutide was developed and marketed by a Danish company, Novo Nordisk. Price for 1mg injection in Pakistan is almost 20,000. Ozempic is available as subcutaneous injection.

It belongs to the class of glucagon-like peptide-1 (GLP-1) analog. It is also indicated for reducing the risk of major adverse cardiovascular events in adults with type 2 diabetes and established cardiovascular disease.

In 2021, Novo Nordisk got approval for its brand Wegovy®. It is also Semaglutide, but it has been approved by USFDA for weight loss. It is approved for weight loss along with reduced calorie diet. Being the same drug, it has to be given once weekly.

Semaglutide is also available as tablets with brand name Rybelsus®, indicated for type 2 diabetes. The tablet is to be given daily.

The only difference between Ozempic® and Wegovey® is that Ozempic is available as multiple use pen, while Wegovy is available as single dose pre-filled syringe in various strengths.

Semaglutide has been found to be effective in reducing blood sugar levels. It also reduces fat by acting on the brain which gives the signals stomach fulness early.

The most common Ozempic side effects are nausea, vomiting, diarrhea, abdominal pain, and constipation. Serious side effects incude allergic reactions, changes in vision, and pancreatitis. It has an FDA boxed warning for the risk of thyroid cell tumors. Potential intestinal blockage has been recently added as a new warning.

Other drugs belonging to GLP-1 class are Tirzepatide, Dulaglutide, Liraglutide etc.

Epidemic of Off Label Use

Ozempic was taken up by influencers and celebrities as a magic drug for reducing weight. The trend caught on quickly and presently the drug is facing worldwide shortage; diabetic patients are unable to get it.

The Conversation article reads, “The headlines squeal with delight: Latest wonder drug will ‘cure’ obesity. We’ve encountered these headlines before. Time and again, dubious and ineffective solutions for obesity gain prominence. Pills, tonics, elixirs, Zumba, Noom and now Ozempic.

The latest wonder drug is a semaglutide drug invented to help diabetics regulate blood glucose levels, but has the notable side-effect of severe weight loss — for which it is prescribed off-label. It has been heralded by many to culminate in the elimination of fat bodies. The fatphobia that undergirds such a proclamation isn’t new. What makes this moment different from the others, however, is the dangerous rhetoric in which it is lodged. This rhetoric elevates the banal and commonplace fat-shaming that fat people must endure and resist to an unprecedented level. Ozempic is being likened to what eyeglasses are to near- or far-sighted people. But, its promise of a fat-free future is unsustainable. It is steeped in fat-hatred that could further damage our relationships to our bodies and food.”

New York Times article reads, “Ozempic, a drug used to treat diabetes, keeps gaining attention as celebrities, a tech mogul and TikTok influencers have described taking it to lose weight in short time frames. The Food and Drug Administration first approved the injectable medication for treating diabetes in 2017; the agency approved a drug with a higher dose of the active ingredient in Ozempic, called semaglutide, to treat obesity in 2021, under the brand name Wegovy. Since then, talk of the drug has popped up across the internet. Elon Musk, when asked about how he looked “fit, ripped and healthy,” tweeted that he was taking Wegovy. On TikTok, the hashtag #Ozempic has been viewed over 273 million times, with people alternately expressing shock over their supposed medication-induced weight loss and swapping stories about side effects.”

Euronews article reads, “A diabetes drug is facing shortages worldwide and causing health concerns as users flood social media with posts boasting its properties as a “wonder” weight loss hack. France’s drug safety agency said this week it was ramping up surveillance measures to ensure that prescriptions of the treatment, Ozempic, are limited to patients with type 2 diabetes. Ozempic has been touted on the Internet as a miracle diet drug. On TikTok, the hashtag #Ozempic already has over 600 million views and counting. Ozempic was not licensed for weight loss, but in 2021 the FDA approved semaglutide, its active ingredient, under the brand name Wegovy for chronic weight management in adults with obesity or overweight with at least one related condition – such as high blood pressure, Type 2 diabetes, or high cholesterol. The US marketing authorisation specifies that Wegovy carries warnings for “inflammation of the pancreas (pancreatitis), gallbladder problems (including gallstones), low blood sugar, acute kidney injury, diabetic retinopathy (damage to the eye’s retina), increased heart rate and suicidal behavior or thinking. Regarding Ozempic, the US National Library of Medicine warns that the injectable drug “may increase the risk that you will develop tumours of the thyroid gland, including medullary thyroid carcinoma (MTC) which is a type of thyroid cancer. Laboratory animals who were given semaglutide developed tumours, but it is not known if this medication increases the risk of tumours in humans. The rampant off-label use of a diabetes drug brings back memories of the Mediator (Benfluorex) scandal in France. The drug was widely prescribed as an appetite suppressant and for weight loss until it was linked to fatal heart problems causing 500 deaths, and pulled from the French market in 2009.”

Forbes article reads, “Ozempic, a FDA approved drug to help decrease blood sugar levels in type two diabetics, continues to be touted by celebrities for one of its off-label uses, weight loss. Even former UK Prime Minister Boris Johnson admitted having taken the drug. If the drug can ultimately result in weight loss and help obese patients curb their weight, then shouldn’t it be lauded as a drug that could transform the obesity epidemic? In theory, people could take Ozempic and lose weight, but still continue with a sedentary lifestyle and eat foods high in cholesterol and fat. While the end result could mean a significant reduction in weight, these same individuals would still be at high risk for cardiovascular disease, heart attacks and stroke.

Marie Claire article reads, “Turn on the television during prime time in the US and you’ll be inundated with ads for semaglutide products. Read American magazines and it’s clear that people who are neither diabetic nor anywhere close to obese or overweight are able to get hold of the medication; privilege pays dividends. Take the New York subway and you’ll see posters unabashedly promoting “a weekly shot to lose weight”, with close-ups of people injecting themselves. The message is in your face: thin is in. It always was and always will be.Even though the messaging is not as conspicuous in Australia – it is illegal for companies to advertise prescription medicines directly to consumers – that doesn’t mean the discourse here around weight loss and beauty standard is any less ugly. For all the progress made in terms of body positivity and acceptance of all body shapes, the clamour for semaglutide is evidence there’s a long way to go.”

Sum Up

Ozempic has a real value for type 2 diabetic patients, and it can reduce weight in obese patients. Having said that, the hype around end of obesity, extreme weight loss, and magic cure are embedded in ignorance. It is a drug with long list of serious side effects and should be used with caution.

Concluded.

Disclaimer: Most pictures in these blogs are taken from Google Images and Pexels. Credit is given where known; some do not show copyright ownership. However, if a claim is lodged at any stage, we shall either mention the ownership clearly, or remove the picture with suitable regrets.

References:

https://theconversation.com/ozempic-the-miracle-drug-and-the-harmful-idea-of-a-future-without-fat-211661

https://www.euronews.com/next/2023/03/02/ozempic-how-a-tiktok-weight-loss-trend-caused-a-global-diabetes-drug-shortage-and-health-c

https://www.forbes.com/sites/omerawan/2023/07/05/the-ozempic-craze-is-sending-the-wrong-public-health-message/?sh=23a2955e31d0

https://www.marieclaire.com.au/about-ozempic-weight-loss-drug

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