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Pharmacovigilance

EMA committee starts review of methotrexate dosing errors

The European Medicines Agency has launched a review of the risk of methotrexate dosing errors, at the request of the Spanish Agency for Medicines and Health Products.

The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has started a review of the risk of dosing errors with methotrexate medicines, which are used to treat cancers and various inflammatory conditions.

When used for inflammatory diseases, such as rheumatoid arthritis and psoriasis, methotrexate is to be taken once a week; however, when being used to treat cancers, such as acute lymphoblastic leukaemia, it is taken more frequently and at a higher dose.

Mistakes can occur when patients with inflammatory diseases are given the dose recommended for cancer patients, resulting in serious consequences, including overdose.

According to the EMA, several measures are already in place in some European Union (EU) countries to reduce this risk; however, adverse events, including fatalities, still occur.

Therefore, the Spanish Agency for Medicines and Health Products asked the PRAC to investigate the reasons for dosing errors and establish preventative measures. Following the review, the PRAC will make a set of recommendations to be forwarded to the Committee for Medicinal Products for Human Use.

In its meeting, held 9–12 April 2018, the PRAC discussed revising its EU-wide recommendation to suspend the marketing authorisation for hydroxyethyl-starch solutions for infusion, used for the management of hypovolaemia (low blood volume) caused by acute blood loss, across the EU. The revision was requested by the European Commission, which said that the PRAC should consider any possible unmet medical need and the effectiveness of risk minimisation measures before going any further.

The review into the safety of quinolone and fluoroquinolone antibiotics, is still undergoing evaluation by the PRAC. The review was triggered in February 2018, at the request of the Federal Institute for Drugs and Medical Devices, the German medicines authority, following reports of long-lasting side effects in its national database and published literature.

Anyone interested in giving evidence to the quinolone and fluoroquinolone public hearing should complete an application form by 30 April 2018. The form can be found on the EMA website as can further information about the PRAC’s latest meeting.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2018.20204691

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