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.
