The National Health Surveillance Agency (Anvisa) recorded 145 suspected pancreatitis notifications associated with the use of medications known as “weight-loss pens” between January 2020 and December 2025. Of this total, six notifications had a suspected death outcome reported by the notifiers themselves, according to the agency. The topic returned to the center of the debate after the growth in the use of these drugs in the country and recent alerts from health authorities abroad.
The data was originally disclosed by O GLOBO, which obtained the survey from Anvisa. The agency emphasizes that these are suspicion notifications recorded in the pharmacovigilance system and that this does not automatically mean confirmation 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. Considering also records from clinical trials, the total reaches 225 notifications in the analyzed period. The data is part of VigiMed, the system used by Anvisa to monitor adverse events related to medications in use in the country.
The historical series shows continuous growth in notifications. In 2020, there was only one record. 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 notifications, a 60.7% increase compared to the previous year. For Anvisa, this increase accompanies the expansion in the use of these medications, including off-label and, in some cases, in the irregular market.
In response to the newspaper, the agency emphasized caution in interpreting the numbers. “It is important to highlight that the cases refer to suspicion notifications reported to Anvisa. We cannot state that they 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.
In the international scenario, the topic has also gained attention. The UK health regulatory agency, 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 reinforced that doctors and patients should be attentive, after identifying particularly severe episodes.
Acute pancreatitis is an inflammatory process of the pancreas caused by the self-digestion of the organ 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 over 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 purplish 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 control of pain, nausea, and vomiting. In more severe situations, it is necessary to treat complications such as infections, respiratory or renal problems, or drops in blood pressure, and surgeries may be indicated in specific cases.
Novo Nordisk, one of the main manufacturers of medications based on GLP-1 analogs, sent a note 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 warning 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 like Ozempic®, Rybelsus®, Wegovy®, Victoza®, and Saxenda®.
The company also advises that patients be informed about characteristic symptoms and that treatment be interrupted in case of suspected pancreatitis, in addition to recommending caution in people with a history of the disease. According to the note, “the frequency and proportion of participants who presented confirmed pancreatitis were similar between semaglutide and comparator in 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 continuous monitoring in collaboration with regulatory authorities.
For Anvisa, the scenario reinforces the importance of responsible prescription and regular medical follow-up, especially given the popularization of these medications beyond their original indications. While investigations and monitoring continue, experts and health authorities highlight that any symptom suggestive of pancreatitis should be evaluated promptly, and that notifying adverse events is essential to improve the safety of using these treatments.
Source: brasil247.com