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FDA alerts health care professionals of risks associated with intraocular use of compounded moxifloxacin

The FDA this week alerted health care professionals of risks associated with intraocular use of compounded moxifloxacin. Following the identification of 29 case reports of TASS (Toxic Anterior Segment Syndrome) following intraocular administration of compounded drugs using moxifloxacin as a bulk drug substance, the FDA is recommending that before health care professionals administer moxifloxacin intraocularly, they know its formulation.

Moxifloxacin topical ophthalmic solutions are FDA approved and marketed under the proprietary names Moxeza and Vigamox. Neither drug is approved for intraocular administration. There are currently no FDA-approved drugs for endophthalmitis prophylaxis.

Without any approved drugs, solutions are being compounded. The agency is alerting all compounders, ophthalmologists, and other health care professionals of risks associated with the intraocular administration of moxifloxacin drugs that contain more than 0.3 mL of 0.5% moxifloxacin or that contain certain potentially harmful inactive ingredients, such as xanthan gum. Many of these compounds are repackaging drugs derived from the FDA-approved topical moxifloxacin drugs which are not meant for intraocular administration.

According to the statement from the FDA, Moxifloxacin is an anti-infective, which, in a dose dependent manner, kills specific microorganisms. Moxifloxacin, in sufficient concentrations, may also contribute to cellular injury in the human body. As such, health care professionals are cautioned to carefully consider the concentration and inactive ingredients of any moxifloxacin drug before intraocular administration.

Read more on this topic from the FDA




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