FDA issues alert on intraocular compounded moxifloxacin

The FDA has received case reports of toxic anterior segment syndrome (TASS) following intraocular administration of compounded drugs using moxifloxacin as a bulk drug substance. In addition, there have been reports associated with the intraocular administration of repackaged and/or diluted FDA-approved moxifloxacin drugs.

Using the adverse event reporting system (FAERS) database for all reports through December 19, 2019, the agency found 29 cases describing TASS associated with intraocular administration of drugs containing moxifloxacin. Sixteen cases involved compounded drugs using moxifloxacin as a bulk drug substance, 10 repackaged Moxeza, 2 unspecified Vigamox and 1 unspecified Moxeza. Nineteen cases reported using moxifloxacin following cataract surgery while the remaining 10 did not specify the type of ophthalmic surgery.

According to 1 facility that reported 10 of these cases, TASS developed within 1 week after intraocular administration of a compounded drug containing moxifloxacin. The report indicated a positive drug-event association: TASS events ceased following discontinuation of moxifloxacin use at the facility and increased again when compounded moxifloxacin was reintroduced during subsequent surgical procedures. While it is not possible to determine whether the TASS events were solely due to intraocular moxifloxacin exposure, the occurrence of additional cases following reintroduction of compounded moxifloxacin reduces the likelihood of other causes.

The FDA is recommending that physicians familiarize themselves with the formulation of moxifloxacin before administering it intraocularly. Compounders, ophthalmologists and other health care professionals should be aware 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. Additionally, the agency cautions health care professionals to carefully consider the concentration and inactive ingredients of any moxifloxacin drug before intraocular administration.

Physicians and patients can report adverse reactions or quality issues to the FDA's MedWatch Adverse Event Reporting program:

• Online: Report adverse reactions or quality problems to the FDA’s MedWatch Adverse Event Reporting
• Mail or fax: Download the reporting form or call 1-800-332-1088 to request one. Complete and return to the address on the pre-addressed form or submit by fax to 1-800-FDA-0178