FDA concerned over MRI drugs
The U.S. Food and Drug Administration released a statement expressing concern over the risks associated with certain imaging agents used during MRI procedures. The agency warned against dangerous side effects of the drugs, especially for people who have existing kidney problems.
The specific substances in question are gadolinium-based contrasting agents which are injected into patients prior to a MRI scan. These agents help produce clearer MRI images for doctors.
Some patients who receive the injections develop a disorder called nephrogenic systemic fibrosis, a condition where the skin and other tissues thicken causing problems with movement and other bodily functions. The risks for this condition, which can prove to be fatal, are drastically higher for patients with kidney disorders, according to the FDA.
FDA officials have been aware of the risks of these potentially dangerous products for a few years, but the warnings have always been a general caution regarding all gadolinium-based agents. Now the agency is saying that specific products may be more dangerous than others and rates for developing the condition may be higher for contrast agents developed by some companies than others.
Specifically, the agents mentioned by the FDA as possibly being more likely to result in the skin condition are GE Healthcare's Omniscan, Bayer AG's Magnevist and Covidien's Optimark. Some of the companies have already issued statements saying they recognize the risks associated with their agents, especially for patients with kidney disorders, but feel there is no conclusive evidence to say that one product is more dangerous than another.
