GE Warned Over Misleading Claims on Imaging Drug

The Food and Drug Administration has warned General Electric Co’s healthcare unit about misleading claims the company made about one of its medical imaging drugs on a promotional website.

The FDA sent a warning letter to the company saying the GE Healthcare website “is misleading because it presents unsubstantiated comparative claims and omits and minimizes the risks associated with Visipaque,” according to a Reuters news report.

The FDA ordered GE Healthcare to stop making the objectionable claims about Visipaque, a chemical agent used to improve the results of diagnostic tests and make them clearer and easier for doctors to read.

Other MRI contrast agents have been linked to a skin disorder called nephrogenic system fibrosis (NSF) and other serious health complications in some patients.

Misleading Statements Targeted

According to the FDA, the company’s claims on the website “misleadingly suggest that Visipaque offers a safety benefit compared to other products due to its unique formulation,” the FDA said.

In reality, the FDA said the agency is “not aware of substantial evidence or substantial clinical experience to support the implication … that patients will be safer or more comfortable if they use Visipaque.”

A GE Healthcare spokesman told Reuters that the company has removed some of the offending claims from the website as a result of the FDA’s concerns. GE Healthcare continues to work on reviewing and updating where appropriate materials related to Visipaque, the company said.

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