Other safety alerts
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| The United Kingdom: Carbimazole: risk of acute pancreatitis |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that cases of acute pancreatitis have been reported very infrequently during treatment with carbimazole. Carbimazole is a prodrug that undergoes rapid metabolism to the active metabolite, thiamazole. Thiamazole (synonym methimazole) is an antithyroid agent that acts by blocking the production of thyroid hormones. Thiamazole is not authorised for use in the UK.
An EU review has found post-marketing reports of acute pancreatitis associated with the use of products containing carbimazole and thiamazole. In the UK, no Yellow Card reports of acute pancreatitis associated with carbimazole treatment have been received over a period of 55 years; however, a small number of reports have been received in other countries. Although the mechanism for development of acute pancreatitis is poorly understood, the presence of cases reporting recurrent acute pancreatitis with a decreased time to onset after re-exposure to carbimazole suggests a possible immunological mechanism.
The product information for products containing carbimazole is being updated to include risk of acute pancreatitis.
Healthcare professionals are advised:
- Cases of acute pancreatitis have been reported very infrequently during treatment with carbimazole.
- If acute pancreatitis occurs, stop carbimazole treatment immediately.
- Do not use carbimazole in patients with a history of acute pancreatitis in association with previous treatment.
- Re-exposure may result in life-threatening acute pancreatitis with a decreased time to onset.
- Carbimazole must be immediately discontinued in patients who develop acute pancreatitis during treatment. Patients should be switched to an alternative therapy on the basis of an assessment of the individual benefits and risks.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-safety-update/carbimazole-risk-of-acute-pancreatitis
In Hong Kong, there are 6 registered pharmaceutical products containing carbimazole, and 2 products containing methimazole. All products are prescription-only medicines. So far, the Department of Health (DH) has received one case of adverse drug reaction related to carbimazole, but this case is not related to acute pancreatitis. The DH has not received any case of adverse drug reaction related to methimazole. In light of the above MHRA’s announcement, letters to inform local healthcare professionals will be issued, and the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board.
Ends/Tuesday, Feb 19, 2019
Issued at HKT 17:00
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