A miracle weight-loss shot is being studied over fears it could increase the risk of cancer.
MailOnline may reveal that health chiefs have called for studies to be launched to monitor any possible link to thyroid and pancreatic cancer.
Groundbreaking study data this week showed that overweight people taking tirzepatide lost an average of 15.6 kg (34.4 lbs) after 72 weeks. They all adopted healthier lifestyles while taking the vaccine once a week.
The company that makes the vaccine, which has been nicknamed the “King Kong” of weight-loss drugs, wants it approved as a specific weight-loss drug in both the US and UK.
Mounjaro, a branded version of the powerful ingredient, has already cleared all regulatory hurdles to treat type 2 diabetes.
According to the latest data, the most commonly reported side effects of tirzepatide, the active ingredient in Mounjaro, were digestive problems. This included about one in five participants who experienced nausea and diarrhea, and about one in ten who reported vomiting or diarrhea
The once-weekly injection works by mimicking certain natural appetite-suppressing hormones. It is the newest drug of its kind to hit the market after Wegovy.
But like the others, too, under the watchful eye of Europe’s health chiefs.
The European Medicines Agency (EMA) said research in rodents suggested the artificial hormones packaged in tirzepatide could increase the risk of medullary thyroid cancer.
Therefore, it has decided that a surveillance study of patients taking the drug is needed to investigate the potential for an increased risk of cancer in humans.
“To assess the potential association, a surveillance study is planned to monitor the annual incidence of MTC and identify any increase associated with tirzepatide,” it said.
A similar observational study is planned for pancreatic cancer, but EMA said there is currently no evidence of a link.
While warning of a potentially increased risk of cancer, EMA noted that there is currently no “pharmacologically plausible mechanism” by which the vaccines could cause cancer in humans.
“The relevance of rodent thyroid tumors to humans is unknown,” said a document from July last year.
Health chiefs also highlighted that identifying such a risk will alter the drug’s “benefit-risk balance.”
Since no significant link between tirzepatide and MTC has yet been established, drug manufacturers do not need to list it as a potential risk.
A Lilly spokesman said: “New drugs are often subject to additional monitoring to ensure we continue to study and evolve the drug’s risk-benefit profile over time.”
“We are working with regulatory authorities around the world to ensure that the safety information on our medicines is kept up to date based on new evidence.”
They added that although the relationship between the drugs like tirzepatide and thyroid cancer is not clear, they are conducting studies to investigate the possibility.
“The concern about the association between exposure to GLP-1 RAs and an increased risk of thyroid tumors is based on preclinical studies in rodents,” they said.
‘Lilly previously recognized the potential risk of medullary thyroid carcinoma MCT associated with GLP-1 RA exposure and is working with regulators to conduct two studies in GLP-1 RAs and thyroid cancer, including MTC.’
The EMA last year recommended Mounjaro for use in the block for patients with type 2 diabetes for reasons similar to those of regulators in the US and UK.
But not only tirzepatid is being monitored by EU health chiefs.
Drugs like semaglutide, the active ingredient in competing vaccines Wegovy and Ozempic, are also being monitored amid similar concerns.
MTC is a rare type of thyroid cancer that accounts for between five and 10 percent of all thyroid cancers in the UK, according to Macmillan Cancer Support.
About three quarters of those affected will be alive five years after diagnosis.
Pancreatic cancer is one of the deadliest forms of the disease, with only 5 percent of people surviving 10 years after diagnosis.
The results of the large tirzepatid study also suggest that it is marginally stronger than its main competitor Wegovy, which is made by Danish company Novo Nordisk and can help people lose between 12 and 15 percent of their body weight, according to studies. Liraglutide and orlistat are already available from the NHS
About 10,000 cases with 9,500 deaths are detected in the UK each year.
Both Wegovy and Mounjaro work in a similar way, using an artificial hormone to trick the body into thinking it’s already full by suppressing appetite.
But Mounjaro differs because it mimics the action of two hormones instead of just one.
Both vaccines are expensive, with Wegovy costing £1,000 (about $1,500) a month, with similar estimates putting Tirzepatide at around £900 a month (about $1,000).
Recent study results for tirzepatide found that participants lost 16 percent, about 34.4 pounds (15.6 kg), on average over 72 weeks when they also adopted a healthier lifestyle.
Crucially, that was far more than the people just adopting the healthier lifestyle, who lost just 3.3 percent of their weight in 72 weeks.
While tirzepatide is available as a diabetes drug in the US, full approval is pending in the UK for the same reasons.
The Medicines and Healthcare Products Regulatory Agency (MHRA) gave its approval to the drug in October, but it is currently under review by the National Institute for Health and Care Excellence (NICE) to make it available to the NHS.
A NICE decision is expected in August.
The hype around tirzepatide has led some sellers to offer the drug to UK buyers under the ‘Research Use Only’ label for around £90 a dose.
Like any drug, tirzepatide has a number of potential side effects that vary in both frequency and severity.
According to the most recent Lilly study of tirzepatide, a study involving over 900 obese/overweight people with type 2 diabetes, the most commonly reported side effects were digestive problems.
This included about one in five participants who experienced nausea and diarrhea, and about one in ten who reported vomiting or constipation.
Lilly said the side effects were most commonly reported during the dose escalation phase.
But current Mounjaro users have reported a number of other uncomfortable side effects similar to those caused by the competing injection called Wegovy, including hair loss.
Commenting on reports of hair loss in people taking Mounjaro, a Lilly spokesperson said: “Hair loss is a side effect that has been associated with significant weight loss in many previous clinical studies treating obesity.”
Fear of side effects hasn’t stopped many from trying the weight-loss vaccine, however, and some took to social media to show off their jaw-dropping 100-lb (45.4 kg) transformations.
Similar to other weight-loss vaccines, people taking tirzepatide are given an initial dose of 2.5 mg once a week.
The graph above shows how the weight loss drug tirzepatide works. It suppresses hunger by mimicking hormones that indicate the body is full. It also shows the passage of food through the stomach by reducing gastric acid production and muscle contractions
A study has shown that the diabetes drug Tirzepatide, sold under the Mounjaro brand, caused participants who were obese or overweight to lose over 15 kg (34 pounds) on average.
This is then increased every four weeks until the maximum target dose is reached.
Participants in the latest study were also required to maintain an energy deficit of 500 kcal per day and engage in 150 minutes of moderate exercise per week.
Lilly said she expects a decision from US regulators by the end of 2023 on approving tirzepatide for some weight loss patients and told MailOnline a filing with UK peers would follow later this year.
Health bosses have hoped that more weight-loss shots coming online could bring the price down, making them more accessible to more people.
NHS figures show 64 per cent of UK adults are overweight, with more predicted to become fatter in the future.
Obesity not only increases Britain’s waistline, it also increases healthcare costs, with the NHS spending an estimated £6.1 billion between 2014 and 2015 on treating weight-related diseases such as diabetes, heart disease and some cancers.
In the United States, about 42 percent of people are obese.
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