FDA Warning Letter Issued over Visipaque Web SiteJan 25, 2010 | Parker Waichman LLP
GE Healhcare is in trouble with the U.S. Food & Drug Administration (FDA) over a Web site for its imaging drug, Visipaque. The agency issued GE a warning letter on January 7, saying the Visipaque Web site is misleading, and omits information about the drug's risks.
Visipaque is used with X-rays to provide clearer images for doctors to read. Visipaque’s label includes a black box that warns doctors and patients about serious side effects, including that it may cause death, convulsions, brain hemorrhaging or cardiac arrest if administered into the spinal cord.
According to the FDA letter, the comparative claims made on the Web site suggest that Visipaque offers a safety benefit compared to other products due to its unique formulation. However, the FDA said that in clinical trials, Visipaque was only comparable in efficacy and safety to other ionic and nonionic imaging agents studied. The FDA also said that an implication that Visipaque is safer than other contrast media in high risk patients (“Patient-procedure friendly, particularly when risk is high”) is not supported by substantial evidence or substantial clinical experience.
The agency also said that the claims on the site misleadingly suggest that Visipaque offers excellent images and results in better diagnostic outcome compared to other products. According to the FDA, this has not been demonstrated by substantial evidence or substantial clinical experience.
The FDA letter also cites the Web site for omitting important information from the drug’s bolded warning regarding serious adverse events reported due to inadvertent intrathecal administration as well as other important risk information. While the FDA acknowledges that the Web site does provide a link to the full Visipaque label, which includes all of the risk information, the agency said that doesn’t mitigate the misleading omission of risk information.
The FDA directed GE to quit making the claims cited in the letter. A GE spokesperson told Reuters that it has removed the information that prompted the FDA letter.