The FDA Takes a New Approach to GBCAs

In the midst of actor Chuck Norris and his wife’s public criticisms of the cognitive and physical repercussions of injecting gadolinium-based contrast agents (GBCAs), the Food and Drug Administration (FDA) has announced they are implementing new safety measures and warnings for the contrast agents used in MRI scans.

According to the FDA’s recent statement, gadolinium can remain in the brain for months or years after being administered. In an effort to inform patients and practitioners about gadolinium retention, the FDA is issuing a new Medication Guide that every patient is encouraged to read before receiving the injection. They’re also demanding drug manufacturers conduct studies to better determine the safety of GBCAs.

This is the first warning the FDA has issued about GBCAs. In the past, they have recommended that physicians “reduce the potential for gadolinium accumulation and “reassess the necessity of repetitive GBCA MRIs in established treatment protocols.” However, this announcement is a pioneering stance on the drug that physicians worldwide have administered 450 million doses of since 1988.

Gena and Chuck Norris are suing McKesson Corporation and other pharmaceutical manufacturers for $10 million for allegedly producing GBCAs that caused Gena to develop Gadolinium Deposition Disease. According to a release from the couple’s attorneys, they have spent $2 million to treat the condition. She has claimed to have suffered from low body temperature, weakness, brain fog, and burning pain as a result of her high Gadolinium levels.

In the FDA statement, however, Gadolinium Deposition Disease isn’t mentioned as a possible risk. Instead, they claim that “the only known adverse health effect related to gadolinium retention is a rare condition called nephrogenic systemic fibrosis (NSF) that occurs in a small subgroup of patients with pre-existing kidney failure.