FDA: Sporanox violations continue

Medical Marketing and Media, Feb 2000 by Dickinson, James G

The FDAs Division of Drug Marketing, Advertising, and Communications (DDMAC) said in a recent letter to Janssen Pharmaceutica that the company continued to promote unapproved uses for its Sporanox (itraconazole) capsules, despite a 1997 letter with the same complaint. Regulatory Review Officer Cheryl Roberts said a number of professional promotional materials for the anti-fungal drug promoted Sporanox pulse dosing in a manner that suggested and represented that it is approved for toenail onychomycosis.

In addition, she wrote, Janssen minimized boxed-warning risks of Sporanox that included death when co-administered with certain drugs metabolized by the cytochrome P450 3A system. And, she said, a statement about potential serious cardiovascular events with the use of Sporanox was placed in a footnote with small print. Roberts cited statements in the materials that she said overstated the efficacy of the drug, as well as claims she said were not backed up by substantial evidence.