FDA finds Braccos imaging agent is misbranded
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IsoVue, an injectable drug designated for angiography throughout the cardiovascular system, has a boxed warning saying it is “not for intrathecal use,” a statement included in the warning section of its product labeling, which also includes other precautionary measures.
The FDA's Division of Drug Marketing, Advertising and Communications has told Bracco Diagnostics that its Web site for IsoVue misbrands the drug by omitting and minimizing the risks associated with the drug and contains false and unsubstantiated claims.
The FDA said that despite the risks associated with the drug, the Web site omits portions of the drugs’ boxed warnings and promotes numerous safety claims for IsoVue. Specifically, the FDA said the summary, design and conclusions sections of the Web site presented the drug information in a misleading manner, and cited font size and graphics used to distract the reader from risk information, while the company promoted the advantages of the drug.
The agency also noted that several Web pages of the IMPACT study site indicate that the research prospectively compared the primary endpoint of incidence of contrast-induced nephropathy (CIN) between IsoVue and GE Healthcare's Visipaque. However, “contrary to these claims," the FDA wrote, "the IMPACT study was not such a study, but rather was a post-hoc combination of two already-completed trials, INVICTA and VIRPACT, that were designed to study image quality as a primary endpoint and that listed CIN risk as a second endpoint.”
In addition, the agency noted that the IMPACT study was not designed to evaluate image quality as an endpoint and the “implied claim” that Isovue offers “the best possible image and the greatest level of safety” minimizes serious risks associated with the drug.
In a letter sent to the director of U.S. regulatory affairs of Bracco Diagnostics, the agency said that Isovue is in violation of the Federal Food, Drug and Cosmetic Act and requested that Bracco “immediately cease the dissemination of violative promotional materials” for the agent. Moreover, the FDA asked that a written response to the letter be submitted on or before Jan. 22, stating any planned intentions for the discontinuation of the aforementioned promotional materials.
Bracco Diagnostics could not be reached for comment as of press time.