Medicinal products can be overlooked as triggers of acute pancreatitis
In rare cases, inflammation of the pancreas can be caused by medicinal products. With the following three case studies from the Swissmedic pharmacovigilance database, Swissmedic is giving a reminder not to forget medicinal products as a possible cause of acute pancreatitis in differential diagnosis.
Incident data |
Description |
|---|---|
Age: 55 Sex: Female Medicinal product: Ozempic® Active substance: Semaglutide Indication: Type II diabetes ADR: Acute pancreatitis |
The patient was admitted to hospital as an emergency with upper abdominal pain radiating to the back. She had increased lipase levels, and acute pancreatitis was diagnosed on imaging. The patient had been treated with semaglutide for one year, which was then discontinued on hospitalisation. Semaglutide was considered to be a possible cause of the acute pancreatitis. No further details are available on the outcome of the adverse drug reaction (ADR). Acute pancreatitis is listed as an uncommon ADR (frequency ≥1/1,000, <1/100) of Ozempic® in the Swiss Information for healthcare professionals. If pancreatitis is suspected, Ozempic® should be discontinued. If acute pancreatitis is confirmed, treatment with Ozempic® should not be restarted. Patients with a history of pancreatitis were not treated with semaglutide in the clinical trials. Caution is therefore advised in these patients. |
Year: 2017 Age: 23 Sex: Male Medicinal product: Imurek® Active substance: Azathioprine Indication: Crohn’s disease ADR: Acute pancreatitis |
This patient with Class 2 obesity had recently been diagnosed with Crohn's disease and began treatment with azathioprine 100 mg/day 20 days earlier. He presented as an emergency with severe upper abdominal pain. Laboratory tests found increased amylase (470 U/L) and lipase (824 U/L). An abdominal X-ray showed no air under the diaphragm and a CT scan found no acute abdominal changes. The clinical picture of acute pancreatitis was attributed to the recently started azathioprine therapy, and the medication was discontinued. The patient was treated with parenteral fluid administration and analgesics. Symptoms decreased with these measures and the increased pancreatic enzymes in the serum returned to normal levels. Various symptoms are described in connection with medicinal products containing azathioprine, which evidently involve hypersensitivity reactions without prior sensitisation such as: feeling generally unwell, dizziness, nausea, vomiting, diarrhoea, fever, muscle and joint pains, skin rash, erythema nodosum, vasculitis, impaired renal function, hepatic disorders and cholestasis, cholestatic jaundice, pancreatitis, abnormal heart rhythms and hypotension. A connection with azathioprine has been confirmed in many cases by re-challenge. Pancreatitis is listed as a very rare ADR (frequency ≥1/1,000, <1/100) in the Swiss Information for healthcare professionals for azathioprine products. |
Year: 2021 Age: 15 Sex: Male Active substance: Isotretinoin Indication: Acne ADR: Acute pancreatitis |
After taking isotretinoin to treat acne, the patient experienced abdominal pain and involuntary vomiting. A blood test showed increased lipase levels, with no evidence of increased triglycerides. A CT scan of the abdomen indicated slightly oedematous acute pancreatitis. The symptoms improved after the medicinal product was discontinued. Pancreatitis is listed as a very rare (frequency <1/10,000) adverse drug reaction in the Swiss Information for healthcare professionals for isotretinoin products. Isotretinoin has been associated with an increase in plasma triglyceride levels. Treatment with isotretinoin must be discontinued when hypertriglyceridaemia cannot be controlled at an acceptable level or when symptoms of pancreatitis occur. Levels exceeding 800 mg/dl or 9 mmol/l are sometimes associated with acute pancreatitis, which can be fatal. |
Although medicinal products are rarely the trigger of pancreatitis, this possibility should always be considered in a differential diagnosis if other causes are excluded.
Healthcare professionals are requested to report serious and/or previously unknown adverse drug reactions to Swissmedic. Please use the Electronic Vigilance Reporting Portal “ElViS” for this purpose.
