General Electric Co's healthcare unit made misleading claims about an imaging drug on a company Web site, U.S. health officials said in a letter released on Friday.
GE Healthcare's Web site "is misleading because it presents unsubstantiated comparative claims and omits and minimizes the risks associated with Visipaque," the U.S. Food and Drug Administration said in a letter to the company.
The FDA told the company to stop using inappropriate claims about Visipaque, which is used with diagnostic tests to provide clearer images for doctors to read.
Claims on the Web site "misleadingly suggest that Visipaque offers a safety benefit compared to other products due to its unique formulation," the FDA said.
The agency said it was "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."
GE Healthcare spokesman Arvind Gopalratnam said the company had removed information from the Web site in response to the FDA's concerns. "The company has taken appropriate actions and is currently reviewing and updating where appropriate materials related to Visipaque," he said.
GE Healthcare does not release sales figures for the product, he said.
The FDA letter was dated January 7 and posted on the agency Web site on Friday.
