Written by: Heather Helmendach, Legal Assistant
Law Offices of Thomas J. Lamb, P.A.
In my last article on Gadolinium based contrast agents (GBCAs), I discussed some of the side effects of these injections, which are administered to patients during a Magnetic Resonance Imaging (MRI) or Magnetic Resonance Angiography (MRA).
While GBCAs have started to draw attention in the pharmaceutical products liability legal realm, they have been the subject of several drug safety regulatory actions here and abroad over the past 12 years.
The timeline below provides dates and descriptions of the regulatory actions pertaining to GBCAs, based on information from the US Food and Drug Administration (FDA).
Timeline of Regulatory Action for GBCAs
The FDA released a Public Health Advisory announcing their investigation of nephrogenic systemic fibrosis (NSF) as a result of GBCA exposure in patients with some degree of kidney failure. A report of 25 cases of NSF served as a catalyst for the FDA's investigation.
|The FDA added a “black box warning” to the drug labels of GBCAs, advising those with renal insufficiency to avoid GBCAs given the increased risk for NSF.
The FDA made a Safety Announcement that they were "requiring changes in the drug label for gadolinium-based contrast agents (GBCAs) to minimize the risk of nephrogenic systemic fibrosis (NSF), a rare, but serious, condition associated with the use of GBCAs in certain patients with kidney dysfunction."
The FDA issued a Drug Safety Communication stating that "Recent publications in the medical literature have reported that deposits of GBCAs remain in the brains of some patients who undergo four or more contrast MRI scans, long after the last administration."
The FDA issued a Drug Safety Communication announcing that they have "not identified adverse health effects from gadolinium retained in the brain after the use of gadolinium-based contrast agents (GBCAs) for magnetic resonance imaging (MRI)."
They also reported that various scientific "publications and [adverse event] reports show that gadolinium is retained in organs such as the brain, bones, and skin. The publications show that linear GBCAs retain more gadolinium in the brain than macrocyclic GBCAs. However, the review did not identify adverse health effects related to this brain retention."
The European Medicines Agency (EMA), however, recommended a ban on the use of Linear GBCAs based on the results of their Pharmacovigilance and Risk Assessment Committee's (PRAC) assessment. They also state that "Although no symptoms or diseases linked to gadolinium in the brain have been reported, the PRAC took a precautionary approach, noting that data on the long-term effects in the brain are limited."
The FDA issued a Drug Safety Communication announcing that they are "requiring a new class warning and other safety measures for all gadolinium-based contrast agents (GBCAs) for magnetic resonance imaging (MRI) concerning gadolinium remaining in patients’ bodies, including the brain, for months to years after receiving these drugs."
|The FDA released new drug labels for GBCAs, which include more information on gadolinium retention.
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Lawsuits are already emerging for conditions such as Gadolinium Deposition Disease (GDD), which are caused by retention of gadolinium in the brain, bones, and other organs.
While the FDA has warned that gadolinium retention is possible after receiving GBCAs, they claim that they have yet to find any evidence that such retention causes serious adverse events in patients with normal / adequate renal function.
It will be interesting to see if further research and publications in the medical literature will cause the FDA to change their position on this issue.
We will continue to monitor the medical and regulatory literature concerning the risk of GDD as a result of GBCA use during MRI and MRA procedures, and report on any significant developments.
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