Safety Alert
This article was originally published in RAJ Devices
Executive Summary
US and Danish regulators issue alert on gadolinium contrast agents
US and Danish regulators issue alert on gadolinium contrast agents
Regulatory authorities in Europe and the US are investigating a possible link between gadolinium-containing contrast agents for magnetic resonance imaging (MRI) and a rare side effect in patients with severely impaired renal function.
The Danish Medicines Agency discovered 25 cases, the oldest dating from 2002, of nephrogenic systemic fibrosis or nephrogenic fibrosing dermopathy (NSF/NFD), a rare disease that causes the skin's connective tissue to thicken and harden, making it difficult to bend joints. The patients, all suffering from kidney failure, developed NSF/NFD after undergoing magnetic resonance angiography (MRA), in which gadolinium contrast agents are injected into patients' veins to take pictures of blood vessels. 20 of the cases were reported in Denmark and the other five in Austria1. All 25 cases involved GE Healthcare's Omniscan (gadodiamide).
Danish regulators contacted other authorities in Europe, and the EU's adverse reactions committee will discuss the safety issue later in 2006. They also sent a letter to the US Food and Drug Administration, which has issued a safety information alert for healthcare professionals and the public, while it investigates the possible link between NSF/NFD and Omniscan2. During its investigation, the FDA has recommended that gadolinium-containing contrast agents not be used in patients with advanced kidney failure unless clearly necessary, and that doctors institute dialysis in patients who do receive MRA.
Gadolinium-containing contrast agents are not approved by the FDA for use in MRA, which uses a dose of contrast agents up to three times higher than that used in MRI scans. Other contrast agents include OptiMark, Magnevist, ProHance and MultiHance; like Omniscan, all are approved in the US for MRI scans3. Omniscan is also available throughout the rest of the world, including eastern Europe, Asia, South & Central America and Australia. GE Healthcare has notified regulatory authorities in all the countries where Omniscan is sold4.
References
1. Press release from Danish Medicines Agency, 29 May 2006, www.dkma.dk/1024/visUKLSArtikel.asp?artikelID=8931
2. FDA safety alert, 8 June 2006, www.fda.gov/medwatch/safety/2006/safety06.htm
3. Personal communication, Danish Medicines Agency, 13 June 2006
4. Personal communication, GE Healthcare, 14 June 2006
(c) Informa UK Ltd 2006