The National Health Surveillance Agency (Anvisa) recorded 145 suspected cases of pancreatitis associated with the use of medications known as “weight-loss pens” between January 2020 and December 2025. Of this total, six notifications reported suspected fatal outcomes by the notifiers themselves, according to the agency. The issue has returned to the center of the debate with the increase in the use of these drugs in the country and recent alerts from health authorities abroad.
The data were originally published by O GLOBO, which obtained the survey from Anvisa (National Health Surveillance Agency). The agency emphasizes that these are notifications of suspected cases recorded in the pharmacovigilance system and that this does not automatically mean proof of a causal relationship between the medication and the cases.
According to the survey, the notifications involve active ingredients such as semaglutide, liraglutide, dulaglutide, and tirzepatide, used in the treatment of diabetes and obesity. Including records from clinical trials, the total reaches 225 notifications in the analyzed period. The data are part of VigiMed, the system used by Anvisa (National Health Surveillance Agency) to monitor adverse events related to medications in use in the country.
The historical series shows a continuous increase in reported cases. In 2020, there was only one case. In 2021, the number rose to 21; in 2022, 23; in 2023, 27; in 2024, 28; and in 2025, there was a jump to 45 reported cases, a 60.7% increase compared to the previous year. For Anvisa (National Health Surveillance Agency), this increase accompanies the expansion of the use of these medications, including off-label and, in some cases, in the illegal market.
In response to the newspaper, the agency highlighted caution in interpreting the numbers. “It is important to emphasize that the cases refer to suspicion notifications reported to Anvisa. We cannot claim that these are confirmed cases.” Pancreatitis is already listed in the package inserts of these medications as a possible adverse effect, and the risk is monitored by regulatory authorities.
On the international scene, the issue has also gained attention. The UK’s health regulatory agency, the MHRA, recently issued an alert about the risk of severe acute pancreatitis in users of obesity and diabetes medications, such as Mounjaro from Eli Lilly and Wegovy from Novo Nordisk. Although severe cases are considered rare, the British authority emphasized that doctors and patients should remain vigilant after particularly severe episodes.
Acute pancreatitis is an inflammatory process of the pancreas caused by the organ’s self-digestion by its own enzymes. The disease can be classified as mild or severe. In mild cases, systemic changes are limited, but in severe forms, organ failure can occur, such as respiratory and renal insufficiency, hypotension, and bleeding, in addition to local complications like necrosis, abscesses, and pancreatic pseudocysts.
According to experts, symptoms usually begin with diffuse abdominal pain, generally in the upper abdomen, which may radiate to the back and increase in intensity in minutes or hours. The pain usually does not improve with painkillers and is often accompanied by nausea and vomiting. Fever, dehydration, tachycardia, and abdominal tenderness may also occur, as well as purple spots on the skin in more severe cases.
The causes of pancreatitis are varied and include, in addition to some medications, conditions such as hereditary pancreatitis, hormonal disorders, metabolic changes, viral infections, vascular diseases, and even surgical procedures. In treatment, the priority is to keep the patient stable, with adequate hydration and pain, nausea, and vomiting control. In more severe situations, it is necessary to treat complications such as infections, respiratory or renal problems, or low blood pressure, and surgery may be indicated in specific cases.
Novo Nordisk, the main manufacturer of medications based on GLP-1 analogs, sent a statement to portal 247 on February 2, 2026, stating that patient safety is a priority and that the company takes “very seriously all reports of adverse events associated with the use of its medications.” In the statement, the company reminds that there is “a class alert for all incretin-based therapies” regarding the risk of pancreatitis and that acute pancreatitis is listed as an adverse reaction in the package inserts of products such as Ozempic®, Rybelsus®, Wegovy®, Victoza®, and Saxenda®.
The company also advises that patients be informed about characteristic symptoms and that treatment be interrupted if pancreatitis is suspected, in addition to recommending caution in people with a history of the disease. According to the statement, “the frequency and proportion of participants who presented confirmed pancreatitis were similar between semaglutide and the comparator in the phase 3 clinical programs (SUSTAIN, PIONEER, STEP)” and most events were classified as mild acute pancreatitis. The company adds that semaglutide was studied in clinical programs with more than 54,000 patients and that post-marketing exposure exceeds 33 million patient-years, with ongoing monitoring in collaboration with regulatory authorities.
For Anvisa (National Health Surveillance Agency), this scenario reinforces the importance of responsible prescribing and regular medical follow-up, especially with the popularization of these medications beyond their original indications. While investigations and monitoring continue, experts and health authorities emphasize that any symptoms suggestive of pancreatitis should be evaluated promptly, and that reporting adverse events is essential to improve the safety of these treatments.
Source: brasil247.com