Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what recent assessment has been made of the side-effects of the drug metamizole.

Metamizole is a medicine used in some European Union countries to treat severe pain and fever. Metamizole magnesium is authorised in Spain, Portugal and Poland (as a generic medicine and under various brand names including Nolotil in Spain and Portugal and Pyralgina in Poland). The medicine has not been licensed for use in the United Kingdom.

As with all medicines, the safety of metamizole is kept under close review within the EU. A European review was conducted last year to assess all data available concerning the maximum daily dose and its contraindications on pregnancy and breastfeeding. This review was completed in December 2018 and led to agreement of harmonised information on the maximum dose to be used and that it should not be used during the third trimester of pregnancy. It was also recommended that use during breast-feeding should be avoided. As a result, consistent warnings will be available in the product information for patients and healthcare professionals within each country where authorised for use.

A recent evaluation by the European Pharmacovigilance Risk Assessment Committee noted reports of cases of agranulocytosis (lowered white blood cell count) which had occurred in UK residents in Spain. Agranulocytosis is a known risk of metamizole and is described in the product information for healthcare professionals. However, based on the review of available data, the Spanish Medicines Agency has taken further action to strengthen the warnings with regards to the risk of agranulocytosis. We are also aware that in October 2018 a communication was issued to healthcare professionals in Spain reminding them of this risk and the need to advise patients of the signs and symptoms and to avoid use in patients who have risk factors for agranulocytosis.

All medicines are supplied with information for patients which contain information on all known side effects and those signs and symptoms which they need to be aware of. Patients being treated with metamizole medicines who have any questions or concerns should talk to a healthcare professional.