The European Medicines Agency (EMEA) has adopted new recommendations for the use of gadolinium-containing contrast agents to minimise the risk of a rare adverse reaction, nephrogenic systemic fibrosis (NSF). NSF is characterised by formation of connective tissues in the skin and internal organs and is only seen in patients with severe kidney problems.
The Danish Medicines Agency brought the safety issue up in the Pharmacovigilance Working Party (PhVWP) in 2006 and initiated in 2008 a so-called article 31 referral to ensure that the safety information be harmonised throughout Europe.
When the European Commission has approved the recommendations, the changes can be implemented in the summaries of product characteristics immediately.
See the announcement 'European Medicines Agency makes recommendations to minimise risk of nephrogenic systemic fibrosis with gadolinium-containing contrast agents' and previous announcements from the Danish Medicines Agency about Omniscan® in the factbox to the right.
For further information, please contact Chief Medical Officer Doris I. Stenver, tel. +45 4488 9247 or +45 2246 0979.
Danish Medicines Agency, 20 November 2009