The FDA warns that an MRI contrast agent is retained in the body and now requires new class warning. The agency has placed stricter warnings on a dye that is commonly used with MRIs. The dye is a contrast agent that contains a metal called gadolinium. During an MRI scan, contrast agents are injected into the body to enhance image quality. The downside of gadolinium is that it can linger in the body for months or years after a patient has received it.
The agency has linked gadolinium retention to a rare skin condition called nephrogenic systemic fibrosis (NSF) that occurs in a small subgroup of patients who have experienced kidney failure.
Healthcare professionals will now be required to provide medical information to all patients receiving gadolinium. In addition, they are advised to consider how much gadolinium will remain in a patient’s body when choosing a gadolinium-based contrast agent (GBCA) for an MRI. Patients at higher risk for gadolinium retention include those requiring multiple lifetime doses, pregnant women, children, and patients with inflammatory conditions.
In a statement, the FDA said, “Gadolinium retention has not been directly linked to adverse health effects in patients with normal kidney function, and we have concluded that the benefit of all approved GBCAs continues to outweigh any potential risks.” Posted December 18, 2017. Via FDA.
The FDA proposes new risk-based enforcement priorities to protect consumers from potentially harmful homeopathic drugs. In the past, the FDA took a hands-off approach to homeopathic drugs, but the huge increase in popularity of these drugs has the agency concerned. The FDA now proposes a more hands-on, risk-based enforcement to regulate those homeopathic drugs with the potential to cause harm. Under this new approach, the FDA will thoroughly examine products designated high-risk, especially products sold to treat infants and children, products that have ingredients with serious safety concerns, such as belladonna, and products sold for crippling conditions such as opioid addiction, heart disease and cancer. Posted December 18, 2017. FDA.
Rattlesnake pill tied to Salmonella Infection. The Centers for Disease Control and Prevention (CDC) announced that a person in Kansas was infected with Salmonella after taking rattlesnake pills purchased in Mexico.
Rattlesnake pills are usually marketed to treat various conditions such as cancer and HIV. The pills contain dehydrated rattlesnake meat ground into a powder and put into pill form. The CDC is advising people to talk to their doctors if they are considering rattlesnake pills, especially people who have weakened immune systems. Posted December 19, 2017. Via Centers for Disease Control and Prevention.