NEUTROPENIA AND AGRANULOCYTOSIS
Manufacturer advises of the importance of recognising
bone marrow suppression induced by carbimazole and
the need to stop treatment promptly.
. Patient should be asked to report symptoms and signs
suggestive of infection, especially sore throat.
. A white blood cell count should be performed if there
is any clinical evidence of infection.
. Carbimazole should be stopped promptly if there is
clinical or laboratory evidence of neutropenia.
MHRA/CHM ADVICE: CARBIMAZOLE: INCREASED RISK OF
CONGENITAL MALFORMATIONS; STRENGTHENED ADVICE ON
CONTRACEPTION (FEBRUARY 2019)
Carbimazole is associated with an increased risk of
congenital malformations when used during pregnancy,
especially in the first trimester and at high doses (daily
dose of 15 mg or more).
Women of childbearing potential should use effective
contraception during treatment with carbimazole. It
should only be considered in pregnancy after a thorough
benefit-risk assessment, and at the lowest effective dose
without additional administration of thyroid
hormones—close maternal, fetal, and neonatal
monitoring is recommended.
MHRA/CHM ADVICE: CARBIMAZOLE: RISK OF ACUTE
PANCREATITIS (FEBRUARY 2019)
Cases of acute pancreatitis have been reported during
treatment with carbimazole. It should be stopped
immediately and permanently if acute pancreatitis
occurs.
Carbimazole should not be used in patients with a
history of acute pancreatitis associated with previous
treatment—re-exposure may result in life-threatening
acute pancreatitis with a decreased time to onset.
PDF page 836
→Appendix 1: carbimazole
PDF page 836
▶Rare or very rare Bone marrow disorders. haemolytic
anaemia. severe cutaneous adverse reactions (SCARs).
thrombocytopenia
▶Frequency not known Agranulocytosis. alopecia.
angioedema. dyspepsia. eosinophilia. fever.
gastrointestinal disorder. generalised lymphadenopathy.
haemorrhage. headache. hepatic disorders. insulin
autoimmune syndrome. leucopenia. malaise. myopathy.
nausea. nerve disorders. neutropenia. pancreatitis acute
(discontinue permanently). salivary gland enlargement.
skin reactions. taste loss
PDF pages 836, 837
The MHRA advises
that females of childbearing potential should use effective
contraception during treatment.
PDF page 837
The MHRA advises consider use only after a
thorough benefit-risk assessment. See Important Safety
Information and Antithyroid drugs p. 814 for further
information.
PDF page 837
Present in breast milk but this does not
preclude breast-feeding as long as neonatal development
is closely monitored and the lowest effective dose is used.
Amount in milk may be sufficient to affect neonatal
thyroid function therefore lowest effective dose should be
used.
PDF page 837
Manufacturer advises use with
caution in mild to moderate insufficiency—half-life may be
prolonged; avoid in severe insufficiency.
PDF page 837