FDA Issues Caution Over Moxifloxacin Eye Injections

Last month, the FDA issued an alert about potential risks associated with the intraocular use of compounded moxifloxacin. The FDA had received reports of toxic anterior segment syndrome (TASS) following injections of compounded drugs containing bulk moxifloxacin or repackaged and diluted FDA-approved moxifloxacin medications. A search of the FDA’s Adverse Event Reporting System database identified 29 cases of TASS associated with drugs containing moxifloxacin. Among the reports, 16 involved drugs compounded with bulk moxifloxacin; 10 were associated with repackaged Moxeza, a preservative-containing form of moxifloxacin; the remaining incidents involved unspecified (repackaged and/or diluted) forms of Vigamox and Moxeza. Nineteen cases involved cataract surgery; the others did not specify the type of eye surgery in which the drugs were used.

The FDA released the alert to inform providers that it’s considering placing bulk moxifloxacin on the list of medications that should not be compounded for ophthalmic use. Many ophthalmic surgeons administer moxifloxacin during cataract surgery to reduce the risk of post-op endophthalmitis, which the FDA says is estimated to occur in .012% to 1.3% of cases.

There is no FDA-approved moxifloxacin product, but approximately half of ophthalmic surgeons administer intracameral moxifloxacin at the time of cataract surgery, according to Eric Donnenfeld, MD, a cataract specialist at Ophthalmic Consultants of Long Island in Garden City, N.Y. “Approximately four million cataract cases are performed each year, so about 2 million patients are administered intracameral moxifloxacin annually,” he says. “With that perspective, twenty-nine cases of TASS is a very low number.”