The FDA’s Division of Drug Marketing, Advertising and Communications (DDMAC) has reviewed GE Healthcare’s Web site for its contrast agent, Visipaque (iodixanol) Injection, and deemed the promotional material “misleading because it presents unsubstantiated comparative claims and omits and minimizes the risks associated with Visipaque.”
Therefore, the agency sent a letter to GE, stating that it has misbranded the drug and is in violation of the Federal Food, Drug and Cosmetic Act. The FDA also said that the company failed to submit a copy of the Web site at the time of its publication.
Specifically, the agency said that the following claims on the company’s Web site are “misleading":
- At all iodine concentrations, [Visipaque] is the only isosmolar contrast medium available for intravascular use.
- Patient-procedure friendly, particularly when risk is high.
- With an osmolality equal to that of blood, Visipaque was designed for patient safety and comfort. Visipaque is also the only contrast medium formulated with sodium and calcium in a ratio equivalent to blood.
- Visipaque is formulated with sodium and calcium at biologic levels.
- With an excellent safety profile, Visipaque is approved for a broad range of diagnostic procedures.
The FDA said that these claims, along with other efficacy claims, are “not supported by substantial evidence or substantial clinical experience.”
Finally, the agency expressed concern over the minimization of risk information. For example, the FDA said that the potential for serious, life-threatening, fatal anaphylactoid or cardiovascular reactions are not disclosed.
“Furthermore, the claims cited in the previous section, which explicitly and implicitly suggest that Visipaque has an 'excellent safety profile,' serve to further minimize the risks associated with Visipaque,” the agency wrote.
In response, GE spokesperson Arvind Gopalratnam said that the company is cooperating with the FDA on the recent notice of violation pertaining to certain Visipaque promotional materials. "The company has taken appropriate actions, and is currently reviewing and updating, where appropriate, materials related to Visipaque," he said.
As a result, the DDMAC requested that GE immediately cease the dissemination of violative promotional materials for Visipaque, and submit a written response by Jan. 22. However, Gopalratnam said that the company received an extension until Jan. 27 to submit its response.