FDA: Blindness Risk From Compounded Vancomycin Eye Injections
October 03, 2017
The US Food and Drug Administration (FDA) is issuing a compounding risk warning against intraocular injections of vancomycin either alone or in combination with other drugs, in light of a new case of hemorrhagic occlusive retinal vasculitis (HORV), a rare event that can cause blindness.
The agency said it received an adverse event report on August 14 from a physician whose patient was diagnosed postoperatively with bilateral HORV after being administered injections of a compounded triamcinolone, moxifloxacin, and vancomycin (TMV) formulation in each eye after cataract procedures that were done 2 weeks apart. Imprimis Pharmaceuticals, Inc, of Ledgewood, New Jersey, had compounded the TMV.
"Health care providers administering eye injections of compounded drugs containing vancomycin for prophylaxis may not be immediately aware of this potentially blinding postoperative complication associated with its use," because the compounded products are not subject to FDA regulations for safety, effectiveness, and quality control, said Janet Woodcock, MD, director of the FDA's Center for Drug Evaluation and Research, in a statement' issued by the agency.
"Raising awareness about emerging safety issues associated with compounded drugs is a top priority for the FDA's compounding program," said Dr Woodcock.
HORV had already been observed in many patients receiving intraocular injections of vancomycin toward the end of otherwise uncomplicated cataract surgeries, said the agency. That prompted the agency on September 28 to add a warning about HORV to the FDA-approved labeling of vancomycin injection stating that the condition had occurred in patients receiving intracameral or intravitreal administration of vancomycin during or after cataract surgery.
The safety and efficacy of vancomycin administered by the intracameral or the intravitreal route have not been established by adequate and well-controlled trials, said the FDA.
This is the third time the agency has issued a compounding risk alert for therapies being used in conjunction with cataract surgery. The FDA previously warned of adverse events associated with a compounded triamcinolone and moxifloxacin product for intravitreal injection, and of two serious adverse eventsassociated with a compounded curcumin emulsion product for injection that was being used for various conditions.
More information about today's announcement is available on the FDA website.
To report any problems with vancomycin injection, contact MedWatch, the FDA's safety information and adverse event reporting program, by telephone at 1-800-FDA-1088; by fax at 1-800-FDA-0178; online at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm; with postage-paid FDA form 3500, available at http://www.fda.gov/MedWatch/getforms.htm; or by mail to MedWatch, 5600 Fishers Lane, Rockville, Maryland 20852-9787.