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Rushing for anti-obesity drugs? Doctors caution against their rampant use

June 12,2024

Mumbai: Of late, the weight loss drugs market has been booming, and it has created a ripple effect globally. These drugs were developed for diabetes management, but they have created a lot of buzz not only in managing diabetes but also in helping with weight loss, benefits in heart, kidney, and liver diseases, and more. Such is the demand for these so-called blockbuster drugs, which have become the most sought-after drugs globally.

Since late, style disorders and diseases have posed a significant challenge; obesity being one of the major concerns, there is a need to address it. According to a recent study published in the Lancet, 70 per cent of India’s urban population is classified as obese or overweight, placing the country amid an obesity crisis. It also states 30 million adults in India are either overweight or obese, and 62 million diabetic Indians exhibit obesity-related characteristics such as excess body fat, abdominal adiposity, and fat deposition in ectopic sites.

Currently, Abbott’s Leptos (sibutramine hydrochloride) is approved for obesity medication in India; the same drug branded as Meridia in 2010 was withdrawn in the US for its increased risk of heart attack and stroke. Eli Lilly’s Zepbound (tirzepatide) and Novo Nordisk’s Wegovy (semaglutideinjection), are expected to make their entry by 2025 and 2026, respectively, in India. As the frenzy for these weight-loss drugs catches on in India, so does the interest in these therapies, as there are limited options in the country: (Source: GlobalData).

Indian doctors have been prescribing these weight-loss drugs even though they aren’t yet commercially sold in India. To better understand this scenario, ETHealthworld interacted with leading diabetologists on how these drugs are procured and administered if they are not available in the Indian market, and there is a global shortfall as well due to high demands.

Sharing his opinion, Dr Rajiv Kovil, Head of Diabetology, Zandra Healthcare, and Co-Founder, Rang De Neela Initiative, shared, “Oral semaglutide has approval in India. Injectable semaglutide at a higher dose has approval in India for obesity. Oral semaglutide which goes by the brand name Rybelsus, has been marketed in India, and its approval is for diabetes, it can be prescribed by doctors in India. Injectable semaglutide is not marketed in India, and injectable semaglutide with a higher dose, which has the brand name Wegovy, has DCGI approval but has not yet been launched and marketed in India. Hence, doctors in India cannot prescribe injectable semaglutide as it has not been marketed in India.”

Dr V Mohan, Chairman and Chief of Diabetology, Dr Mohan’s Diabetes Specialities Centre, added, “Semaglutide is available in both oral (tablet) form, which is known as Rybelsus, as well as injectable form, which is known as Ozempic and Wegovy. Rybelsus has already been available in India for the last few years, and that is being used (prescribed) by all of us. While it is effective, it is not as effective as the injectable forms, namely Ozempic and Wegovy. Wegovy was approved earlier this year by the Drug Controller General of India (DCGI), and the company has been permitted to market it in India. However, the fact is that despite the injectable form, both Ozempic and Wegovy are much more effective in weight reduction and controlling diabetes, but they are unable to bring them to India immediately because of the heavy demand for their production. They have been struggling to produce enough to sell in Europe, the US, the Middle East, and other countries where the drug is available.

Inquiring about how Indian medical practitioners prescribe these drugs for weight loss in non-diabetic patients, Dr Kovil said, “Indian prescriptions cannot be used to obtain these drugs from overseas markets, but whichever country semaglutide has been launched in, whether it is the UAE, Saudi Arabia, the UK, or the US, the healthcare practitioner based in the country is required to prescribe this drug as this is not an over-the-counter medication. The medication has to be prescribed only by experts in the field. Semaglutide injectable has been approved for diabetes as well as weight loss. Though injectable semaglutide has been approved in India, it has not been marketed. Oral semaglutide which is approved, marketed, and available in India, has received approval only for the management of type 2 diabetes and cannot be used for the treatment of obesity in people without diabetes. There are a lot of people with diabetes who are fighting obesity, and breaking the obesity pandemic in people with diabetes is itself a challenge. So, semaglutide oral, which goes by the brand name Rybelsus, is the drug of choice or pill for diabetics who want to lose weight or who don’t want to gain weight.”

Dr Mohan mentioned that since it is not available in the Indian market, some Indians are procuring these drugs from Dubai or other sources and using them. He stated, “The problem if the drugs are used without being available in India is that if any side effects develop, then the question of who is responsible will arise. Will the current company still be held responsible if the patient has illegally obtained the drug from some other country? If a legal issue like this arises, it could lead to complications. Hence, in my view, until it is officially available through proper sources, that is, through hospitals, clinics, or pharmacies in India, people shouldn’t import the drugs and use them on their own.”

The side effects that are seen are mostly gastrointestinal, nausea, vomiting, and diarrhoea being the most common. Very rarely, they can lead to a condition called paralysis of the stomach and intestine. Even more rarely, pancreatitis and medullary carcinoma of the thyroid have been reported. However, these are more common in animal models when higher doses are used, and they are very uncommon in human trials. If the patients start using these drugs, they lose weight, and the sugars get under control. However, they have to be on it long term because if they stop it, they tend to gain weight again. After all, these drugs work only as long as they are taken. Since they’re very expensive, we as doctors always find out whether patients can afford to take these drugs long-term before we prescribe them.”

Even though these drugs have various benefits and the interest in them is ever-increasing, various side effects need to be taken into consideration. Sharing his views on the side effects of these drugs, Dr Kovil said, “The common effects seen globally and as well as in India of GLP-1 analogues are purely related to the GI system because the movement of the stomach is reduced and one can have upper GI irritation and upper GI acidity, dyspepsia.”

Dr Kovil further shared what happens when people are put off these drugs; he said, “Obesity is a lifelong disorder like hypertension, cholesterol abnormalities, and diabetes. Hence, the treatment for it should also be lifelong. Patients who take medications and then give up medication tend to gain weight. This is also observed with semaglutide globally, where almost 50 per cent of patients may gain 50 per cent of weight in the one year they stop the molecule. Weight seems to be the mother of all non-communicable disorders, and it is essential to treat the core problem of weight to reduce the morbidity and mortality associated with diabetes, cardiovascular disease, cancer, hypertension, and dyslipidemia. Weight management could be treating the core defect in many problems, and we end up treating the risk factors rather than treating the core problem.”

In conclusion, Dr Mohan said, “We are all waiting for the injectable forms of semaglutide to officially come to India. It has been reliably learned that maybe next year, it will be available in the Indian market.”

The growing demand for medications that help people lose weight, such as semaglutide, emphasises how critical it is to treat obesity, a serious health issue in India. Although injectable versions of semaglutide (Ozempic and Wegovy) have been approved for use in treating diabetes, their market debut is still pending due to significant demand worldwide. Experts advise against using it under supervision and stress the significance of long-term care for long-term weight loss. Ensuring safe and accessible obesity management is crucial, especially as India prepares for the official launch of these injectables. The country’s approach to treating obesity and associated lifestyle diseases may be greatly impacted by the incorporation of these therapies.

Source: Healthworld

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