Last week, many media outlets reported on a press release from the UK Medicines and Healthcare products Regulatory Agency (MHRA). It sought the collaboration of people hospitalized with acute pancreatitis. The goal was to investigate whether the risk of pancreatic inflammation in people taking GLP-1 medicine for weight loss or type 2 diabetes, such as the popular drug Ozempic, could be genetically influenced. Alison Cave, head of safety at the MHRA, estimates that one-third of adverse reactions could be prevented with prior genetic testing. The British media picked up the release and expressed alarm over 10 drug-related deaths and hundreds of cases of pancreatitis in people taking these kinds of medication.
Despite the eye-catching headlines from the United Kingdom that spread to the rest of the world, the information that’s been published makes it impossible to determine whether there really is a serious problem with drugs that are being used more frequently and with less control. Pancreatitis is a problem that was seen in the clinical trials that led to the approval of these drugs. In the case of semaglutide, it was observed in less than 0.5% of patients. Neither the MHRA nor the media have offered data to suggest that figures are exceeding these levels among British users.
For Cristóbal Morales, an endocrinologist at the Virgen Macarena University Hospital in Seville, Spain these “are very safe drugs that have been used for 20 years in diabetes,” but he warns that “the information appearing in the product data sheets for drugs like semaglutide has been taken from clinical trials involving physicians who are experts in the pathology, with monthly or quarterly monitoring.” However, he considers there is a danger in “the widespread use of drugs, sometimes purchased online or on the black market, prescribed for cosmetic purposes or by unprepared individuals.” In these cases, the side effects could be far greater than those anticipated by the manufacturers.
A study published in June estimates that nearly one million people in the UK are taking GLP-1 drugs such as Ozempic, Wegovy, or Mounjaro solely for weight loss. If we add those who, in addition to weight loss, use them for diabetes or cardiovascular problems, the figure rises to 1.6 million. With these numbers, even if there were many more than the 560 cases of pancreatitis recorded by the MHRA, according to The Times, the percentage would still be much lower than what is reported in the data sheets, which is still no reason to neglect oversight of drugs whose use continues to grow.
The report, signed by researchers at University College London, states that 15% of those who injected one of these weight-loss drugs in the past year used a drug not approved for that purpose. This occurs, for example, when using Ozempic, approved for diabetes, instead of Wegovy, produced by the same company, Novo Nordisk, but approved for weight loss. In both cases, the active ingredient is semaglutide, but it is administered in different doses.
Andreea Ciudin, coordinator of the Comprehensive Obesity Treatment Unit at Vall d’Hebron Hospital in Barcelona, warns of two seemingly opposing risks that share a lack of precision in the use of these medications. On the one hand, she considers it dangerous to use pancreatitis as a generic term because it can have many causes, ranging from alcohol consumption or a viral infection to obesity or diabetes and the use of medications, including GLP-1 inhibitors. “Many doctors routinely order a pancreatic enzyme test, and this is a mistake, because a diagnosis of pancreatitis requires abdominal pain, elevated pancreatic enzymes, and an imaging test to confirm the condition,” she explains. “We know that these drugs can slightly elevate pancreatic enzymes in a completely asymptomatic manner, especially at the beginning of treatment, but that doesn’t mean there is pancreatic damage,” she continues. “There aren’t many cases, and we need to look at how the diagnoses were made, and what medication they were taking, to see what’s really going on, because often this information comes out and there’s no way to get it out of people’s heads,” she adds. “There are millions of people being treated, and we can’t draw erroneous conclusions based on just a few cases,” Ciudin says.
But at the same time, the endocrinologist insists that “this medication is serious; it must be prescribed by multidisciplinary teams, by doctors with experience in managing these drugs and who can accurately prescribe the treatment.”
“It’s a treatment for a disease, not for cosmetic reasons, and it can’t be administered lightly, for bikini surgery,” she adds. Doses should be tailored to the individual, then escalated according to each individual’s particular needs over a long period of follow-up. “There are people who buy the medication and start with the maximum entry dose; this is a tremendous digestive storm,” she notes. “The message is that these are not treatments to be taken lightly and offered just anywhere.”
The European Medicines Agency (EMA) did not respond to this outlet’s queries about the alert reported in the British media.
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