A Web site for GE Healthcare’s <"http://www.yourlawyer.com/practice_areas/defective_drugs">Visipaque imaging drug is misleading, and omits information about its risks, according to a letter the U.S. Food & Drug Administration (FDA) sent to the company on January 7.
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. In particular, the letter said the presentations indicate that Visipaque has superior patient safety and comfort characteristics because it is isosmolar to blood/formulated with sodium and calcium in a ratio equivalent to blood. However, the FDA said it not aware of substantial evidence or substantial clinical experience to support the implication created by these claims that patients will be safer or more comfortable if they use Visipaque instead of other contrast media. In clinical trials, Visipaque was only comparable in efficacy and safety to other ionic and nonionic imaging agents studied, the FDA said.
The FDA also said that an implication that Visipaque is safer than other contrast media in high risk patients (â€œPatient-procedure friendly, particularly when risk is highâ€) is not supported by substantial evidence or substantial clinical experience.
The letter also says that the Web site includes the following claims regarding Visipaqueâ€™s efficacy:
â€¢ â€œ(Visipaque) provides excellent diagnostic efficacy.â€
â€¢ â€œ(Visipaque) helps improve efficiency, and maximize[s] contrast for high-quality images and diagnostic outcomes.â€
According to the FDA, these claims misleadingly suggest that Visipaque offers excellent images and results in better diagnostic outcome compared to other products, when 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 drugâ€™s bolded warning regarding serious adverse events reported due to inadvertent intrathecal administration as well as other important risk information. The only risk information included on the Web site are general statements concerning the risks of blood coagulation, clotting, thromboembolic events, and cautious use in certain disease states, the agency said.
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 also said that the GE failed to submit a copy of the Web site at the time of its publication. The letter states that GE has misbranded the drug and is in violation of the Federal Food, Drug and Cosmetic Act.
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.