The EMA has started a review of metamizole, the active ingredient of Novalgina, to evaluate the risk of agranulocytosis, a serious adverse reaction associated with this drug
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L’European Medicines Agency (EMA) recently started a review of medicinal products containing metamizolea painkiller used to treat pain and fever, known to be the active ingredient in Novalgina.
The EMA’s insights into metamizole arise from concerns about the risk of agranulocytosis, a serious adverse reaction associated with this drug.
Agranulocytosis involves a drastic reduction in neutrophils, a type of white blood cell essential for fighting infections. This condition can lead to serious and life-threatening infections.
Currently, product leaflets containing metamizole list agranulocytosis as a rare or very rare side effect, but case reports persist even after enhanced safety measures have been implemented to reduce the risk.
It was in particular theFinnish Medicines Agency to request EMA review after reporting new cases of agranulocytosis. In response to these reports, the company that markets the only medicine containing metamizole in Finland has requested the withdrawal of its authorization for safety reasons.
Metamizole is widely used in many European Union countries to treat various types of pain. The peculiarity, however, is that its availability and authorized uses vary considerably between different member states.
The EMA’s Safety Committee (PRAC) will now review the risk of agranulocytosis for all metamizole-containing medicines authorized in the EU. The review will include an assessment of existing risk minimization measures and the impact of agranulocytosis on the benefit-risk balance of medicines.
At the end of the evaluationthe PRAC will publish a recommendation on whether to maintain, vary, suspend or revoke the marketing authorizations for these medicines across the EU.
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Source: Aifa
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