FDA requires a warning on Gadolinium Contrast Agents

The U.S. Food and Drug Administration (FDA) has issued a new advisory requiring a new class warning and other safety measures for all gadolinium-based contrast agents (GBCAs) for magnetic resonance imaging (MRI) regarding gadolinium remaining in patients’ bodies, including the brain, for months to years after receiving these drugs which may be linked to renal harm.   These agents have been associated with nephrogenic systemic fibrosis in patients with pre-existing renal failure.  Although this complication is rare, it is serious enough to justify the advisory to all professionals and patients.

Although the benefit of all approved GBCAs continues to outweigh any potential risks the FDA now requires several actions to alert health care professionals and patients about gadolinium retention after an MRI using a GBCA, including actions that can minimize problems.  Health care professionals should consider the retention characteristics of each agent when choosing a GBCA for patients who may be at higher risk for gadolinium. These patients include those requiring multiple lifetime doses, pregnant women, children, and patients with inflammatory conditions. FDA suggests fewer repeated GBCA imaging studies when possible, particularly closely spaced MRI studies. However, physicians are advised to not avoid or defer necessary GBCA MRI scans.

Patients, parents, and caregivers should carefully read the new patient Medication Guide that will be given to him before receiving a GBCA. The Medication Guide explains the risks associated with GBCAs.  It also asks the patient to inform health care professional about medical conditions, such as: pregnancy, date of last MRI and number of prior MRI with gadolinium and kidney problems.

All new patients will be provided with the Medical Guide that provides educational information that every patient will be asked to read before receiving a GBCA. FDA will also require manufacturers of GBCAs to conduct human and animal studies to further assess the safety of these contrast agents.