FDA Alerts Health Care Professionals of Risks Associated with Intraocular Use of Compounded Moxifloxacin

https://www.fda.gov/drugs/drug-safety-and-availability/fda-alerts-health-care-professionals-risks-associated-intraocular-use-compounded-moxifloxacin?utm_campaign=FDA%20alerts%20health%20care%20professionals%20of%20risks%20associated%20with%20intraocular%20use%20of%20compounded&utm_medium=email&utm_source=Eloqua

FDA Alerts Health Care Professionals of Risks Associated with Intraocular Use of Compounded Moxifloxacin

Ophthalmologists frequently administer moxifloxacin and other anti-infective agents either topically or intraocularly to reduce the incidence of postoperative endophthalmitis.  Endophthalmitis occurs at a low incidence following cataract surgery (estimated to be between 0.012% 1.3%).1 There are currently no FDA-approved drugs for endophthalmitis prophylaxis.  Outsourcing facilities have compounded moxifloxacin drug products from bulk drug substances and repackaged the FDA-approved topical moxifloxacin drugs. Traditional and hospital pharmacies (generally, those that operate under section 503A of the Federal Food, Drug, and Cosmetic Act), as well as individual ophthalmologists have used moxifloxacin ophthalmic solutions, approved for topical administration, as the starting material to prepare moxifloxacin drugs for use during intraocular procedures. FDA received case reports of TASS (Toxic Anterior Segment Syndrome) following intraocular administration of compounded drugs using moxifloxacin as a bulk drug substance, as well as reports associated with the intraocular administration of repackaged and/or diluted FDA-approved moxifloxacin drugs. FDA searched the Adverse Event Reporting System (FAERS) database for all reports through December 19, 2019, and identified 29 cases that described TASS associated with intraocular administration of drugs containing moxifloxacin (16 compounded drugs using moxifloxacin as a bulk drug substance, 10 repackaged Moxeza, 2 unspecifieda Vigamox, and 1 unspecifieda Moxeza). The majority of cases (n = 19) reported use of moxifloxacin following cataract surgery and the remaining 10 did not specify the type of ophthalmic surgery. According to one facility that reported 10 of these cases, TASS developed within one week after intraocular administration of a compounded drug containing moxifloxacin. The report indicated a positive drug-event association, as the TASS events ceased following the discontinuation of the use of moxifloxacin at the facility. When the compounded moxifloxacin drug was reintroduced during subsequent surgical procedures, patients again presented with TASS. While it is not possible to determine if the TASS events were solely due to exposure to intraocular moxifloxacin, the occurrence of additional cases following re-introduction of compounded moxifloxacin use reduces the likelihood of other causes. FDA recommends that before health care professionals administer moxifloxacin intraocularly, they know its formulation. The agency also alerts 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.8,9 Additionally, FDA cautions health care professionals to carefully consider the concentration and inactive ingredients of any moxifloxacin drug before intraocular administration. Read More

For more information, please visit FDA's  Human Drug Compounding  web site.