Dear Doctor Letter (Rote-Hand-Brief) on medicinal products containing carbimazole or thiamazole: risk of acute pancreatitis and strengthened advice on contraception
2019.02.06
Active substance: carbimazole, thiamazole
After completion of a European signal procedure and in coordination with the Federal Institute for Drugs and Medical Devices (BfArM), the marketing authorisation holders of drugs containing carbimazole and thiamazole shall inform about
- the risk of acute pancreatitis, and
- the urgent recommendation that women of childbearing age use effective methods of contraception during treatment with carbimazole or thiamazole.
There are reports of acute pancreatitis from routine use of medicinal products containing carbimazole or thiamazole. In the light of case reports of recurrent acute pancreatitis with a shortened time to onset when carbimazole or thiamazole is reapplied, any future re-treatment with carbimazole or thiamazole is contraindicated in patients who have previously experienced acute pancreatitis during treatment.
In addition, carbimazole and thiamazole are suspected of causing congenital malformations when administered in high doses during pregnancy, especially in the first trimester of pregnancy.
It is recommended that women of childbearing age use effective methods of contraception during treatment with carbimazole or thiamazole.
Upon recommendation by the European Medicines Agency (EMA), further warnings on the risks assessed in the signal procedure are included in the Package Leaflet and Summary of Product Characteristics.
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