The FDA's advertising division has cited ISTA Pharmaceuticals for running a misleading journal ad that fails to disclose risks associated with its spreading agent Vitrase.
The agency's Division of Drug Marketing, Advertising and Communications (DDMAC) informed ISTA of the ad's shortcomings in a recentuntitled letter, which was posted to the FDA's website.
"Although the journal ad presents several effectiveness claims for Vitrase, it fails to include any of the warnings associated with use of the drug or the precaution regarding the incompatibility with furosemide, benzodiazepines, and phenytoin as stated above," the letter states. "The only risk information included in the ad is excerpted from the adverse reactions section of the [product labeling]. By omitting the most serious and frequently occurring risks associated with the drug, the journal ad misleadingly suggests that Vitrase is safer than has been demonstrated."
The FDA approved Vitrase (hyaluronidase) in May 2004 as an adjunct to other injected drugs to increase their absorption and dispersion. The injectable drug has been used most commonly in combination with local anesthetics in the setting of ophthalmic surgery. Vitrase is also approved for use as an adjunct to rehydrating agents, and for use with certain imaging agents.
DDMAC asked ISTA to immediately stop using the ad and submit a written response to the untitled letter by Nov. 16. To view the untitled letter, go to http://www.fda.gov/cder/warn/2005/VitraseNOVltr.pdf (http://www.fda.gov/cder/warn/2005/VitraseNOVltr.pdf).