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For Those Considering "Dropless" Cataract Surgery: Risks of Compounded Medications
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.
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.
The eye surgeon that will be doing my first cataract surgery later this month uses a different dropless technique. I found a recent online EyeWorld2 Ophthalmology article (April 2017) about dropless cataract surgery and he was quoted there telling about his own technique:
“My choice is moxifloxacin with dexamethasone (Ocular Science), which I inject directly into the anterior chamber after cataract surgery. The combination consists of 0.5% moxifloxacin and 0.1% dexamethasone, giving 0.15 cg of this mix. What gets into the eye would be approximately 750 micrograms of the moxifloxacin and 150 micrograms of the dexamethasone. After I’ve taken the cataract out, I check my incisions like I normally would to make sure the incisions are water-tight. Then I use a 1cc syringe and an AC cannula (27 or 30 gauge) through the paracentseis site, and go right underneath the anterior capsule and inject,” he said. According to Dr. Mah, dexamethasone is a preferable choice over triamcinolone due to its shorter half-life of 7 to 8 days, voluminous data of use in ophthalmology compared to all other steroids, and clarity of the preparation. As most cataract patients would not require steroids after surgery for any longer than 2 weeks, dexamethasone would very likely be sufficient coverage. A huge advantage is that compared to the murkiness of triamcinolone that obscures early postoperative vision and requires transzonular or pars plana application, dexamethasone is clear and can be left in the anterior chamber without concern—even in glaucoma patients. When he was at the University of Pittsburgh, Dr. Mah’s colleagues published a paper with higher amounts of intracameral dexamethasone in glaucoma patients being safe and effective following routine cataract surgery. Dr. Mah thinks that anterior segment surgeons who do not normally deal closely with the vitreous might feel uncomfortable and avoid vitreous manipulations if possible. Surgeons unaccustomed to working beyond the anterior segment might feel uncomfortable trying to perform a transzonular or pars plana drug delivery approach, which may invalidate TriMoxi from their list of options, while intracameral application would be more attractive to them. “Injecting into the anterior capsule is not challenging for anterior segment surgeons. That’s just my own assessment. Obviously there are surgeons out there successfully using TriMoxi and other formulations using vitreous approaches which is great, but for me, I just don’t feel as comfortable and I’m glad I don’t have to learn a new technique or disturb the zonules or vitreous,” Dr. Mah said.
“My choice is moxifloxacin with dexamethasone (Ocular Science), which I inject directly into the anterior chamber after cataract surgery. The combination consists of 0.5% moxifloxacin and 0.1% dexamethasone, giving 0.15 cg of this mix. What gets into the eye would be approximately 750 micrograms of the moxifloxacin and 150 micrograms of the dexamethasone. After I’ve taken the cataract out, I check my incisions like I normally would to make sure the incisions are water-tight. Then I use a 1cc syringe and an AC cannula (27 or 30 gauge) through the paracentseis site, and go right underneath the anterior capsule and inject,” he said. According to Dr. Mah, dexamethasone is a preferable choice over triamcinolone due to its shorter half-life of 7 to 8 days, voluminous data of use in ophthalmology compared to all other steroids, and clarity of the preparation. As most cataract patients would not require steroids after surgery for any longer than 2 weeks, dexamethasone would very likely be sufficient coverage. A huge advantage is that compared to the murkiness of triamcinolone that obscures early postoperative vision and requires transzonular or pars plana application, dexamethasone is clear and can be left in the anterior chamber without concern—even in glaucoma patients. When he was at the University of Pittsburgh, Dr. Mah’s colleagues published a paper with higher amounts of intracameral dexamethasone in glaucoma patients being safe and effective following routine cataract surgery. Dr. Mah thinks that anterior segment surgeons who do not normally deal closely with the vitreous might feel uncomfortable and avoid vitreous manipulations if possible. Surgeons unaccustomed to working beyond the anterior segment might feel uncomfortable trying to perform a transzonular or pars plana drug delivery approach, which may invalidate TriMoxi from their list of options, while intracameral application would be more attractive to them. “Injecting into the anterior capsule is not challenging for anterior segment surgeons. That’s just my own assessment. Obviously there are surgeons out there successfully using TriMoxi and other formulations using vitreous approaches which is great, but for me, I just don’t feel as comfortable and I’m glad I don’t have to learn a new technique or disturb the zonules or vitreous,” Dr. Mah said.
3 Comments
Hope it works well for you.
Its not completely "dropless" but a significant reduction in drops/day.
I only have to use two eyedrops a day for 4 weeks after surgery:
Durezol (1drop/day) - steroid
Ilevro or Bromsite (1drop/day) - NSAID
I only have to use two eyedrops a day for 4 weeks after surgery:
Durezol (1drop/day) - steroid
Ilevro or Bromsite (1drop/day) - NSAID
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