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New rules for heart scan aims to reduce excessive radiation exposure

Instructions for a recalled device and drug used to produce scans to evaluate the heart have been revised in an effort to determine what may have caused excess radiation in some patients. The CardioGen-82 PET scan, made by Bracco Diagnostics Inc., is used to perform cardiac positron emission tomography (PET) scans with the radioactive drug rubidium (Rb)-82 chloride injection to evaluate the heart. The Food and Drug Administration (FDA) has received reports of two patients who received more radiation than expected from CardioGen-82. The excess radiation was due to strontium isotopes which may have been inadvertently injected into the patients ... Read More

Heart scan patients may have been over-exposed to radiation

Patents who underwent or will be undergoing cardiac positron emission tomography (PET) scans with rubidium (Rb)-82 chloride injection from CardioGen-82 manufactured by Bracco Diagnostics, Inc. may have inadvertently been exposed to a higher than expected amount of radiation. While the Food and Drug Administration (FDA) believes that the risk of harm from this exposure is minimal, any unnecessary exposure to radiation is undesirable. A CardioGen-82 PET scan is one of a variety of nuclear medicine scans and uses the radioactive drug Rb-82 chloride injection to evaluate the heart. FDA has received reports of two patients who received more radiation than ... Read More

Gadolinium federal lawsuits move ahead

Injecting a toxic liquid metal such as gadolinium into the bloodstream may seem like a procedure from a sci-fi horror movie, but it is a common, every day occurrence in medical centers throughout the country. When gadolinium is in the bloodstream, medical imaging devices produce clearer, more defined images of the patient’s blood vessels. Since gadolinium is extremely toxic to human tissue, it must first be coated with a benign chemical before being injected into the patient. Over the course of time, the body expels the metal through the kidneys. Patients with poor kidneys, however, experience a buildup of the toxic ... Read More

MRI contrast agents get strong kidney-risk warning

Certain contrast agents used in magnetic resonance imaging — gadolinium-based products made by Bayer AG, GE and others — will now carry the U.S. Food and Drug Administration’s strongest, “black box” warning. The FDA’s move on Friday finalizes its announcement in May that it would add the labeling warning to the MRI contrast agents. The final warning notes that the agent boosts the risk of a potentially fatal side effect in patients with certain kidney and liver conditions. The skin disease called nephrogenic systemic fibrosis, or NSF, can occur in some patients, the companies said in a joint letter to ... Read More