Most of the gadolinium-related adverse reactions reported recently are related to one particular agent -- gadodiamide -- according to preliminary data from a Danish radiologist.
Most of the gadolinium-related adverse reactions reported recently are related to one particular agent - gadodiamide - according to preliminary data from a Danish radiologist.
To date, up to 400 cases of a life-threatening condition known as nephrogenic systemic fibrosis (NSF) have occurred in patients with renal failure, according to Dr. Henrik Thomsen, who has collected survey results for the the European Society of Urogenital Radiology, which has members in Europe and the U.S.
Nearly all reports involved gadodiamide (Omniscan), which is manufactured by GE Healthcare, and most adverse events happened in the U.S., said Thomsen.
"This is mainly, if not only, a one-product problem," Thomsen said.
Patients with a glomular filtration rate of <30 mL/min and those on dialysis are at risk and should not receive gadodiamide, he said. There have also been some worrisome reports of patients with a serum creatinine below 2 mg/dL after gadodiamide administration, however, suggesting that the threshold could be set higher at <60 mL/min.
In June 2006, the FDA advised against giving gadolinium-containing contrast agents during MRI exams to patients with renal impairment. The warning came after the Danish Medicines Agency reported that 25 patients with kidney failure developed NSF. Thomsen's research grew out of the agency's report.
Five agents with gadolinium are approved for use in MR imaging in the U.S.: Omniscan, OptiMARK, Magnevist, ProHance, and MultiHance. The FDA has not approved gadolinium contrast agents for MR angiography, which can require three times the dose used with MRI.
The FDA is investigating all gadolinium-containing contrast agents to determine whether they do in fact cause NSF in patients with renal failure, as this patient group was not typically represented in premarketing studies.
GE issued a warning in June coinciding with the FDA warning. It has also sent letters to all customers in all markets where the health authorities permitted and notification and has posted a warning on its Web site.
In a response to a previous story on this topic in November, GE said that it strongly urges caution in the administration of gadodiamide contrast in renally impaired patients. The mechanism of NSF/NFD is not currently well understood, and other issues (such as other drugs) may be contributing factors.
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