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« FDA Warns Companies Marketing Unapproved Ergotamine Tartrate | Main | What side affects should be reported after Gadolinium injections? »

March 05, 2007

What side affects should be reported after Gadolinium injections?

The FDA is urging patients to call their doctor right away if any time after the gadolinium injection the following conditions happen.

Skin and eyes: Swelling, hardening and tightening of skin, reddened or darkened patches on the skin, burning or itching of skin and yellow raised spots on the whites of the eyes.

Bones and muscles: Stiffness in joints; problems moving or straightening arms, hands, legs, or feet, pain deep in hip bones or ribs and muscle weakness.

What should healthcare providers do in response to this new information?

According to the FDA, physicians should consider the risks and benefits of using gadolinium-based contrast agents for MRI or MRA in patients with moderate to end-stage kidney disease. If such a patient receives gadolinium-based contrast agent, the physician should consider prompt dialysis.

What additional actions are likely to follow?

The FDA will complete its ongoing analysis of these preliminary findings and then consider multiple options such as: modifying the product label or requiring additional studies. FDA may also consider other risk management options.

Where can I find more information about gadolinium-based agents and about NSF/NFD?

The package inserts provide additional information about each of the approved gadolinium-based agents.

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