Follow-up on previous announcements, clickable in the right-hand factbox.
In the spring of 2006, the Danish Medicines Agency initiated an investigation by the EU Pharmacovigilance Working Party of the safety of gadolinium-containing MRI contrast mediums in kidney patients.
The safety investigation was initiated in continuation of the receipt of 20 Danish reports on suspected serious adverse drug reactions, first of all nephrogenic systemic fibrosis (NSF) seen after the use of the contrast medium Omniscan®.
NSF is a rare condition characterised by fibrosis of the skin and internal organs. In some cases, the condition is so severe that the patient is confined to a wheelchair. There have also been deaths that may presumably be partly ascribed to the condition.
Already in May 2006, the Danish Medicines Agency issued a warning about suspected serious adverse reactions associated with the use of Omniscan® and other gadolinium-containing contrast mediums.
There was agreement among the EU authorities that it was necessary to initiate an investigation of the safety of the use of a total of 8* gadolinium-containing MRI contrast mediums marketed in the EU. The authorities primarily wanted to confirm or refute the suspicion raised and to obtain an overview of whether or not the same risks were associated with all gadolinium-containing mediums or whether there were differences.
The investigation has now substantiated that there might be a connection between gadolinium and the development of NSF in kidney patients. In addition, investigations have shown that the risks may vary between individual gadolinium-containing products. Such variation may be ascribed to the products' specific physico-chemical and pharmacokinetic matters**.
On 5 February 2007, Omniscan® was contraindicated in kidney patients; Magnevist® was contraindicated in kidney patients later that year. In respect of the other products, cautious use is recommended in kidney patients.
For further information, please contact Chief Medical Officer Doris I. Stenver, telephone +45 4488 9247.
The Danish Medicines Agency, 22 February 2008
(*) Omniscan®, Magnevist®, Multihance®, Primovist®, Vasovist®, Prohance®, Gadovist®, Dotarem®.
(**) High risk: Omniscan®, Magnevist®; medium risk: Multihance®, Primovist®, Vasovist®; low risk: Prohance®, Gadovist®, Dotarem®.