A regulatory official with the FDA sent a warning letter to Inspire Pharmaceuticals in April. The letter took issue with Inspire’s advertising of its drug AzaSite (azithromycin 1%).

“The Journal Ad is false or misleading because it broadens the indication, makes unsubstantiated claims and omits and minimizes important risks associated with the use of AzaSite,” the FDA letter says. “Therefore, the Journal Ad misbrands AzaSite in violation of the Federal Food, Drug and Cosmetic Act … and FDA implementing regulations.” (Note: This ad has appeared several times in Review of Optometry.)

In particular, the FDA pointed to a claim that the drug “can restore a healthy ocular surface by delivering significant anti-inflammatory…effects.” This, says the FDA, is “misleading because it implies that AzaSite delivers anti-inflammatory effects, when this has not been demonstrated by substantial evidence or substantial clinical experience.” For this claim, the ad cites references to in vitro studies, not clinical trials.

The FDA letter also says the advertising also omits information about serious risks associated with the drug, specifically it fails to warn about “the risk of anaphylaxis and hypersensitivity with systemic use of azithromycin, including reports of fatalities, growth of resistant organisms with prolonged use, and avoidance of contact lenses.”

The FDA said the company must immediately “cease the dissemination” of any ads that make these claims. Inspire had issued no response at press time; however, its advertising has been amended.