Gadolinium-Based Contrast Agents and Black Box Warnings

by Administrator 7. June 2011 03:02

Recently, federal officials have issued a black box warningon all gadolinium-based MRI contrast agents.

In the United States, a black box warning is a type ofwarning that appears on prescription drugs that may causes serious adverse effects.A black box warning is the most severe warning issued by the United States Foodand Drug Administration. It is so named for the black border that usuallysurrounds the text of the warning on a drug’s package insert.

The FDA can require a pharmaceutical company to place ablack box warning on the labeling of a prescription drug if it has been shownto cause serious or fatal health problems. One of the most recent black box warningsissued by the agency was for gadolinium-based contrast agents. The contrastagents containing gadolinium have been linked to the rare and potentially fataldisease nephrogenic systemic fibrosis.

If you have developed nephrogenic systemic fibrosis afterbeing administered an MRI contrast agent containing gadolinium, please contactthe NSF Lawyers of Williams Kherkher by calling 800-761-3187.

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