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FDA Wants Warning On MRI Contrast Agents


MRI scans are as common as x-rays these days. But here is a news report that will make you think twice before you enter the belly of that scanner. On Wednesday the Food and Drug Administration issued a statement asking manufacturers of certain contrast agents, used in patients who get MRI scans, to place a black-box warning on the agents so patients are aware of the risks involved. Apparently these agents can be lethal to patients who have severe kidney problems, according to an article posted on CNN.

According to this article, the warning would involve five gadolinium-based contrast agents, some of which are manufactured by General Electric Co.’s health care unit as well as BAY, an arm of Bayer and Tyco. FDA officials say these agents, when used on someone with severe kidney problems, “could cause a debilitating and potentially fatal disease called nephrogenic systemic fibrosis.” Among others who are at risk are patients who are undergoing a liver transplant or those with chronic liver disease.

FDA officials say this condition, commonly referred to as NSF, can cause thickening of the skin and connective tissues and restricts their mobility resulting in broken bones. This type of fibrosis may also develop in the diaphragm, thigh and lower abdominal and lung vessels. NSF is a debilitating condition that results in gradual deterioration and may eventually lead to death. The agents in question are used to enhance visibility of internal organs when patients undergo an MRI. According to FDA officials, the contrast agents are not required for an MRI to be done.

There are consequences and side effects for every drug or medical procedure we expose ourselves to. Some side effects result in nausea and dry mouth, while others are deadly. Drug makers and medical procedure performers have a duty to provide us adequate information regarding the consequences and side effects, so that we can make informed decisions regarding the risks and benefits of the drug or medical procedure.

The fact that you can develop a potentially fatal disease just by taking a contrast agent to enhance an MRI scan is enough to call for these warnings. Now what remains to be seen is if the information on the box is going to get to the patients. It’s not clear how many patients have already been affected or have died as a result of these agents being used in the procedure.

At Bisnar Chase Personal Injury Attorneys, we’ve assisted thousands of people who have fallen victim to the side effects of drugs that they were not made aware of. Often, the drug manufacturer can be held liable when they push a drug into the market despite knowing (or should have known) of serious effects that the drug has that might outweigh the benefits of taking the drug. A case in point is Merck’s Vioxx. The fast selling arthritis drug was pulled off the shelf after hundreds of thousands of patients experienced side effects such as heart attack and stroke.

If you have experienced serious side effects of a defective drug, call me. If you have questions about whether you might have a case, ask me. I’m always here and available to answer your questions. 1-800-259-6373.

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