Other safety alerts
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| European Union : Review of painkiller metamizole started |
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European Medicines Agency (EMA) announces that its Pharmacovigilance Risk Assessment Committee (PRAC) has started a review of medicines containing the painkiller metamizole following concerns that the measures in place to minimise the known risk of agranulocytosis may not be effective enough.
Metamizole-containing medicines are authorised in a number of European Union (EU) countries for treating moderate to severe pain and fever. The authorised uses vary from country to country, ranging from the treatment of pain following surgery or injuries to the treatment of cancer-related pain and fever.
Agranulocytosis is a known side effect of metamizole-containing medicines. It involves a sudden and sharp decrease in the levels of granulocytes, a type of white blood cell. This can lead to serious infections which can be fatal. The product information of the various metamizole-containing medicines currently lists agranulocytosis as either a rare side effect (occurring in up to 1 in 1,000 people) or a very rare side effect (occurring in up to 1 in 10,000 people). Measures in place to minimise this risk vary across countries.
The review was started at the request of the Finnish medicines agency as cases of agranulocytosis are still being reported with metamizole despite the recent strengthening of risk minimisation measures in Finland. Following the most recent reports of cases, the company marketing the only metamizole containing medicine authorised in Finland requested that its marketing authorisation be withdrawn for safety reasons.
The PRAC will now review the risk of agranulocytosis for all metamizole containing medicines authorised in the EU in their different authorised uses, and their existing risk minimisation measures. It will assess the impact of agranulocytosis on the benefit-risk balance of the medicines and issue a recommendation on whether their marketing authorisations should be maintained, varied, suspended or revoked across the EU.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/en/news/review-painkiller-metamizole-started
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/ Saturday, June 15, 2024
Issued at HKT 13:30
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