MISLEADING TRAVATAN PROMOTION PROMPTS WARNING LETTER

The FDA's advertising division has issued Alcon an untitled letter for disseminating a flash card promotion that contains unsubstantiated comparison and superiority claims for its ophthalmic solution Travatan.

"The flash card is false or misleading because it fails to reveal material facts, presents unsubstantiated superiority claims, broadens the indication, minimizes risks and presents dosing claims that are unsubstantiated and inconsistent with the approved product labeling for Travatan," the FDA's Division of Drug Marketing, Advertising, and Communications (DDMAC) writes in the recent letter. "These violations are concerning from a public health perspective because they suggest that Travatan is safer or more effective than has been demonstrated, and they encourage use in circumstances other than those for which the drug has been shown to be safe and effective."

The FDA took exception with several components of the flash card, including language claiming Travatan (travoprost) is more effective than Pfizer's eye drug Xalatan (latanoprost). DDMAC said the comparison is misleading because the drugs are approved for different indications.

The agency also objected to language in the flash card comparing Travatan to Allergan's rival drug Lumigan (bimatoprost). Alcon's promotion suggests that because the products work on different receptors, Travatan is associated with less inflammation.

In addition to making unsubstantiated superiority claims, the flash card minimizes risks associated with Travatan by implying that hyperemia, a side-effect that results in the treated eye appearing red, diminishes over time, the letter states. DDMAC said it is unaware of evidence supporting the hyperemia claim.

To view the warning letter, go to http://www.fda.gov/cder/warn/2005/Travatan-ltr.pdf (http://www.fda.gov/cder/warn/2005/Travatan-ltr.pdf).