a warning that the elderly may be at particular risk of NSF due to impaired ability of their kidneys to clear gadolinium from the body;
a statement that there is no evidence to support the initiation of haemodialysis to prevent or treat NSF in patients not already undergoing haemodialysis
a statement that the type and dose of contrast agent used should be recorded.
2. More information is available in a question-and-answer document.
3. The procedure was carried out under Article 31 of Directive 2001/83/EC as amended, for nationally authorised gadolinium-containing agents, and under Article 20 of Regulation (EC) No 726/2004 for centrally authorised agents. This type of procedure may be initiated in specific cases where the interest of the Community is involved. The expression 'Community interest' has a broad meaning but it refers particularly to the interests of the public health in the Community, for example following concerns related to the quality, efficacy and/or safety of a medicinal product or new pharmacovigilance information.
4. Gadolinium-containing contrast agents are: gadoversetamide (OptiMARK), gadodiamide (Omniscan), gadofosveset (Vasovist), gadoxetic acid (Primovist), gadobenic acid (MultiHance), gadopentetic acid (Magnevist, Magnegita and Gado-MRT-ratiopharm), gadobutrol (Gadovist), gadoteric acid (Dotarem), gadoteridol (ProHance). Most of gadolinium-containing medicines are authorised nationally. OptiMARK and Vasovist are authorised centrally.
5. A public statement on the association between gadolinium-containing contrast agents and the NSF was published in February 2007: http://www.emea.europa.eu/pdfs/human/press/pus/4974107en.pdf
6. This press release, together with other information on the work of the European Medicines Agency, can be found on the Agency website: www.emea.europa.eu