FDA Says Doctors Should Consider Limiting MRIs As Agency Investigates Risks To Brain
The Food and Drug Administration issued the safety announcement as it looks into whether contrast-imaging drugs that contain the heavy metal gadolinium leave brain deposits after repeated MRIs. Meanwhile, a new report suggests that drug makers delay filing reports with the FDA in cases of a drug-related illness or death.
FDA Determines Whether MRI Drugs Accumulate In Brain Tissue
The Food and Drug Administration announced today it is investigating the risk of brain deposits for patients who are given repeated MRIs using imaging drugs that contain a heavy metal. The FDA did not announce any label changes for the nine medicines that contain the metal, gadolinium, saying there was a “need for additional information.” However, “to reduce the potential for gadolinium accumulation,” the safety announcement asked health care professionals to “consider limiting” their use and to reexamine “the necessity of repetitive” MRIs involving these drugs. (Gerth, 7/27)
The Philadelphia Inquirer:
Drug Makers May Delay Reporting Patient Harms To FDA: Study
Drug companies may be endangering the lives of patients by not promptly reporting cases of drug-related illness or death to federal regulators, a new report suggests. About 10 percent of cases where a drug does serious harm to a person are not reported to the U.S. Food and Drug Administration within the required 15-day period, the new analysis reveals. (Thompson, 7/27)