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New Warnings Required by the FDA on some Imaging Drugs

The United States Food and Drug Administration (FDA) has issued new warning label requirements for injectable imaging drugs known as gadolinium-based contrast agents (GBCA). In a September 9, 2010 statement, the FDA warned that three of these drugs—Magnevist, Omniscan, and Optimark—can cause potentially fatal side effects in patients with certain types of kidney disease. The FDA is requiring the strongest type of warning—a bold box at the top of the label—for the three drugs.

Gadolinium-based contrasting agents

Gadolinium is a rare element which is used in intravenous imaging drugs which patients receive before undergoing magnetic resonance imaging tests. Seven GBCA’s are currently in use. Magnevist is manufactured by Bayer, Omniscan by General Electric Healthcare, and Optimark by Covidien. The other GBCA’s are Ablavar from Lantheus Medical Imaging, Eovist from Bayer, and Multihance and Prohance from Brocco Diagnostic Inc..

Nephrogenic systemic fibrosis

The FDA states that new warning labels must contraindicate the use of these three drugs in patients with acute kidney injury or chronic severe kidney disease. Patients in these groups are at a higher risk of developing nephrogenic systemic fibrosis (NSF) after receiving these drugs. NFS is a rare, potentially fatal condition which leads to hardening of the skin, joints, eyes, and internal organs. There have been no reported cases of NFS among patients with normal kidney function.

Symptoms of NFS include burning, scaling, or hardening of the skin, swelling, stiffness, muscle weakness, and red or dark patches on the skin. The FDA is advising patients with kidney disease who have received GBCA’s to report any of these symptoms to their doctor.

Other recommendations

The risk for NSF also appears to be higher among patients with impaired drug elimination. The FDA recommends that patients with this condition should not receive any GBCA unless it is essential. Patients with impaired drug elimination should be monitored for NFS if they receive this drug. The risk of NFS is also increased with multiple injections in a single imaging session; GBCA’s should be administered only once per session.

Conclusion

The FDA first reported cases of NFS in kidney patients who had received GBCA’s in 2006. The agency states that it will continue to monitor the effects of all GBCA’s for possible association with NSF. Labels on all GBCA’s will state that all patients should be screened for kidney disease before receiving any of these drugs. The FDA is recommending that all NFS cases be reported to the agency.

Sources:

FDA News Release: New warnings required on use of gadolinium-based contrasting agents

FDADrug Safety: New warnings for using gadolinium-based contrast agents in patients with kidney dysfunction

The Free Dictionary: Medical Dictionary: Gadolinium

Associated Press: FDA warns of deadly side effects with imaging drugs

Associated Press: Correction: Imaging drug story