Don’t expect magic: The rise of Mounjaro and the risks of off-label use for weight loss

While doctors say the drug holds promise, promise for obesity management, it comes with potential side effects, long-term costs.

Published Apr 12, 2025 | 7:00 AMUpdated Apr 12, 2025 | 7:00 AM

Don’t expect magic: The rise of Mounjaro and the risks of off-label use for weight loss

Synopsis: Despite its growing popularity in India as a weight-loss aid, Mounjaro – a diabetes drug approved only for type 2 diabetes – is being increasingly prescribed off-label, raising concerns among medical professionals. Doctors warn that while the drug shows promise for obesity management, it is not a quick fix and comes with potential side effects, long-term costs, and the risk of misuse, especially in cases lacking proper supervision.

Since its launch in India earlier this year, US drugmaker Eli Lilly’s Mounjaro (tirzepatide) has rapidly captured the attention of those grappling with weight loss – whilst some doctors appear all too willing to prescribe it.

Although the weekly injection was officially approved by the Central Drugs Standard Control Organisation (CDSCO) for managing type 2 diabetes, its off-label use for obesity is what has been driving the growing interest.

At ₹14,000 per month for the lowest dose, it is over 95 percent cheaper than its United States counterpart, Zepbound.

It works by activating GIP and GLP-1 receptors, helping to regulate insulin, reduce appetite and burn fat – particularly for those with a body mass index (BMI) over 30, or over 27 with related health issues – which is attracting growing interest.

With more than 100 million Indians affected by diabetes and obesity, the drug could really be a game changer.

But can people without diabetes take it safely? Is it meant for short-term use, or long-term treatment? Doctors say the drug holds promise, but urge caution.

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Is off-label use safe? 

“In India, Mounjaro has been approved only for people with diabetes,” said Dr Vidya Tickoo, Consultant Endocrinologist and Diabetologist at Yashoda Hospital in Hyderabad, speaking to South First. “But if you look at reports, everyone’s talking about it as a weight-loss injection – and yes, studies in the United States and other countries show it is being used effectively for that purpose, even in non-diabetics.”

So what does that mean for patients in India?

“Technically, yes – it can be used for obese individuals who are not diabetic, because the evidence is there, through multiple studies,” Dr Tickoo said.

But others warn against unsupervised use.

“This medication must only be taken under the guidance of a qualified doctor,” said Dr Rajeev Jayadevan, a Kochi-based gastroenterologist.

“While it is approved for obesity treatment in the United States, that is not the case in India yet. Off-label use has to be carefully assessed by the prescribing physician. Self-use is risky – rare but serious side effects have already been reported.”

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Is BMI the only criteria?

Dr Tickoo said BMI plays an important role in deciding who should take Mounjaro, but it is not the only factor.

“We generally consider it for people with a BMI above 30,” she said. “But if someone has a BMI above 27 and is also dealing with obesity-related complications like diabetes, obstructive sleep apnoea, fatty liver, arthritis, or heart problems – then yes, they can be considered for it too.”

She stressed that lifestyle changes must come first.

“We always advise patients to begin with diet and exercise. There has to be a trial of at least three to six months. These medications should only come in if lifestyle modification does not work.”

There are some exceptions.

“Some people cannot exercise effectively – those with severe joint pain, sleep apnoea, or heart issues caused by obesity. For them, it makes sense to start treatment earlier,” Dr Tickoo said. “In such cases, it is a very helpful molecule.”

She also raised a concern that some patients may misunderstand the drug’s purpose.

“A lot of people are now saying, ‘We will just take it for three months to lose weight,’” she said. “That is not how it works. It is not a quick-fix or a short-term solution.”

Dr Jayadevan agreed. “Yes, the Food and Drug Administration (FDA) recommends it for people with a BMI above 30, or above 27 with health conditions,” he said. “But we also have to remember that in Asian populations, including India, the BMI cut-offs are different.”

He explained that risks can arise at lower BMI levels.

“A BMI over 25 can already be risky for Indians because of how body fat is distributed. And anyway, BMI is just a rough tool – it does not tell you if the weight is fat or muscle, or where that fat is located in the body.”

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The hidden obesity risks

Although BMI is the most widely used tool for assessing obesity and prescribing weight-loss drugs such as Mounjaro, many doctors say it does not capture the full picture – especially for Indian patients.

“In India, we often see people with a normal BMI but high abdominal fat,” said Dr Vidya Tickoo. “That is why we do not rely on BMI alone when assessing obesity.”

She explained that other measures can be just as important. “Waist circumference is a key one – more than 90 cm for men and 80 cm for women is considered high. Then there is body fat percentage, which we can assess using a Dexa scan. If it is more than 25 percent in men or 35 percent in women, that is classified as obesity too.”

So could someone with a normal BMI still be prescribed Mounjaro?

“Yes,” Dr Tickoo said. “If they meet those other criteria, they may still be considered obese. BMI is simple and widely used, but it is not absolute.”

Dr Rajeev Jayadevan agreed, saying abdominal obesity is often more predictive of health risks than overall BMI.

“Waist circumference is a better measure in clinical practice,” he said. “Excess fat around the abdomen – visceral fat – is strongly linked to diabetes, heart disease, and metabolic syndrome, unlike fat stored in the hips or thighs.”

He added that the medical community is gradually shifting its focus. “Globally, there is increasing recognition that abdominal fat is the real danger. But because BMI has been the gold standard for so long, that change is happening gradually.”

“In fact,” he noted, “many Indians fall into the TOFI category – ‘thin outside, fat inside.’ They look lean but have significant abdominal fat. That is why relying solely on BMI can be misleading when it comes to deciding treatment options.”

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Not a quick fix

One of the key concerns around Mounjaro – and similar drugs used for weight loss – is whether the benefits last after the treatment ends. Is it a short-term aid, or a lifelong commitment?

“That is the big downside,” said Dr Jayadevan. “Many people regain the lost weight once they stop the injections. This is not unique to Mounjaro – it is a trend seen across this entire class of drugs. And let us not forget, these medicines are expensive. So, both cost and the potential side effects have to be considered seriously before deciding to stay on them long-term.”

Dr Tickoo shared similar concerns and underlined the long-term nature of obesity management.

“Ideally, obesity medicines should be treated just like blood pressure or diabetes medicines – something you may need to take lifelong,” she said.

She pointed to research showing that some patients regained weight after stopping treatment. “In one trial, after stopping the drug, around 50 percent of patients gained back part of their lost weight within the following months,” she said. “That is because the drug suppresses appetite. Once you stop it, hunger returns – and so does the weight.”

She also noted that it takes time to reach the full therapeutic effect. “It is not like you take it for a couple of months and expect magic. And even after reaching the full dose, it ideally needs to be continued.”

But patients do not always see it that way.

“People say, ‘I will take it for three months, lose weight, and then maintain.’ But practically, that rarely works. The body tends to bounce back unless lifestyle changes are deeply embedded,” Dr Tickoo said.

While some studies show a degree of weight regain after treatment ends, the long-term effects remain uncertain.

“We are dealing with a new molecule. The longest follow-ups are only around a year or so,” she said. “In some cases, people gained back half the weight they had lost. Give it two more years, and they might be right back where they started. We just do not know yet.”

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Risk of counterfeit drugs 

As interest in Mounjaro grows across India, so too do concerns over counterfeit and black-market versions of the drug.

Even before its official launch, the drug was being hailed online as a weight-loss breakthrough, prompting some people to seek it abroad – especially in Dubai.

“That is always possible – everything is possible in India,” said Dr Vidya Tickoo. “Even before it launched here officially, people were already getting it through the black market. Some were bringing it in from Dubai, others were sourcing it unofficially.”

Mounjaro has only recently become available in Indian pharmacies, but doctors say demand was already building. The looming expiry of the patent on Ozempic, a related drug from Novo Nordisk, could add further complexity.

“We will have to see how many companies jump in with their own versions,” Dr Tickoo said. “That might be good in terms of affordability – but it also opens the door for misuse and spurious copies.”

Dr Rajeev Jayadevan voiced similar concerns.

“Unfortunately, yes – the risk is real,” he said. “We have already seen counterfeit versions of these drugs pop up in Western countries. Combine high demand with India’s track record of counterfeit or substandard drugs – like we saw during COVID – and you have the perfect recipe for a black-market boom.”

He warned that poor-quality imitations could be dangerous.

“These drugs act on metabolic pathways – using a fake or poorly made version is not just ineffective, it can be dangerous.”

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Is it worth it?

Mounjaro might be significantly cheaper in India compared to United States prices, but at ₹3,500 per weekly dose – or ₹14,000 per month – it is still beyond affordability for many, especially when prescriptions are made without detailed discussion or clear need.

Dr Sunita Sayammagaru, a diabetologist based in Hyderabad, recalled a recent case that raised red flags.

“A patient came to me after being prescribed Mounjaro by a corporate hospital doctor,” she said. “His HbA1c was 6.4 percent, which is actually well controlled. His BMI was 30 – not severely obese. He and his family were shocked when they realised how much it would cost to stay on the drug.”

The patient had been advised to continue for 18 months – a total of ₹2.52 lakh.

“For a middle-class family, that is an enormous burden,” Dr Sayammagaru said. “And no one had properly discussed side effects or long-term plans. They just handed the prescription and moved on.”

She chose to stop the injection and instead prescribed a low-cost oral anti-diabetic drug, along with detailed lifestyle guidance.

“He did not need Mounjaro. It was not life-saving in his case – it was optional. What he needed was proper counselling, and time to decide.”

Dr Sayammagaru said patients deserve full transparency, particularly with expensive long-term medication.

“Why prescribe such a costly medication without first assessing if the person can afford it, or even needs it urgently? The patient should have been sent home with all the information, given a couple of days to think, and then decide.”

She added: “It is okay if people do not believe this happens. But it does. Every day. In real clinics.”

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Medical warnings and risks

According to Eli Lilly, Mounjaro carries several important warnings and potential side effects. These include:

  • Thyroid tumours: Mounjaro may increase the risk of thyroid cancer. It should be avoided by anyone with a personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
  • Pancreatitis: Stop taking the drug immediately if severe abdominal pain occurs, with or without vomiting.
  • Hypoglycaemia: Particularly when used with insulin or sulfonylureas. Symptoms include sweating, dizziness, blurred vision, fast heartbeat and mood changes.
  • Allergic reactions: Serious cases may involve swelling of the face or throat, difficulty breathing, rash or dizziness. Immediate medical help is advised.
  • Kidney problems: Vomiting or diarrhoea may lead to dehydration and worsen kidney function.
  • Stomach issues: Some users report persistent or severe stomach pain.
  • Vision changes: Report any changes to your doctor.
  • Gallbladder problems: Watch for symptoms such as jaundice, abdominal pain, fever, or pale stools.
  • Aspiration risk during surgery: Patients should inform doctors before undergoing any procedure.

(Edited by Dese Gowda)

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