US FDA publishes public health advice on steroid-containing contrast agents

Release date: 2006-08-28

US FDA publishes public health advice on steroid-containing contrast agents. The US Food and Drug Administration (FDA) issued public health advice on steroid-containing contrast agents. Advice, the FDA is currently evaluating important safety information about the association between steroid-containing contrast agents and a neurotransmitter/nephrogenic fibrotic skin disease (NSF/NFD). This disease usually occurs in patients with kidney failure.
The monitoring report found a possible link between NSF/NFD and high doses of sputum-containing contrast agents in magnetic resonance angiography (MRA). The MRA examination uses magnetic resonance imaging to photograph blood vessels. In the MRA examination, a contrast agent known to contain sputum is injected into the vein of the patient so that the blood vessel can be distinguished from adjacent tissue.
The FDA has been informed that 25 patients with renal failure have reported a case of NSF/NFD after MRA with Omniscan, a contrast agent containing strontium. The FDA is currently actively investigating whether exposure to steroid-containing contrast agents during M-RA is associated with the development of NSF/NFD disease. During the FDA investigation, the following recommendations are made to health care providers and patients:
Intravenous contrast agents, especially at high doses, should only be used when patients with severe renal insufficiency must be used. Patients with severe renal insufficiency are those who currently require dialysis or glomerular filtration rate (GFR) ≤ 15 cc/min.
For patients with severe renal insufficiency, timely dialysis can be considered after MRA with steroid-containing contrast agents. Although there is currently no data to determine that patients with reduced renal function undergo dialysis to prevent or treat NSF/NFD, the mean clearance of sputum reached 78%, 96%, and 99% after the first to third hemodialysis, respectively.
The FDA has approved five steroid-containing contrast agents for magnetic resonance imaging (MRI). The five steroid-containing contrast agents are available under the trade names Omniscan, OptiMARK, Magnevist, ProHance, and MultiHance. These drugs are not approved by the FDA for MRA. The dose of the steroid-containing contrast agent used in the MRA examination is usually higher than the dose of the approved MRI examination (up to 3 times).
NSF/NFD was first discovered by scientists in 1997, and the pathogenesis is still unclear. NSF/NFD appears to occur in patients with renal failure and high levels of humoral acid, a known acidosis state common in patients with renal failure. NSF/NFD patients have tight, hard skin, which makes joint bending difficult. NSF/NFD can also cause fibrosis or scarring of body organs, resulting in loss of function of human organs, failure to function properly, and death. About 200 cases of NSF/NFD have been discovered worldwide.
The Danish Medicines Authority reported 25 cases of NSF/NFD on May 29, 2006. Of these, 20 occurred in Denmark and 5 in Austria. The patient developed NSF/NFD within 3 months (2 weeks to 3 months) after receiving the sputum-containing contrast agent.
The FDA has not been able to determine whether patients with renal failure use N-type contrast agents in MRA to cause NSF/NFD. The FDA is collecting additional information about NSF/NFD to investigate whether other NSF/NFD patients have also received steroid-containing contrast agents.
Source: China Medical News

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