Preserved Kenalog linked to multiple cases of sterile endophthalmitis
NAPLES, Fla. — Several cases of sterile endophthalmitis have been associated with intravitreal injection of a preserved triamcinolone acetate formulation within the past 4 months, according to a surgeon speaking here.
|
Alexander Eaton, MD, reported on the phenomenon at the Florida Society of Ophthalmology annual meeting. He discussed several cases from his own experience, as well as from surgeons throughout the United States. All have been associated with intravitreal injection of preserved Kenalog (triamcinolone acetate, Bristol-Myers Squibb).
Since May, Dr. Eaton said, he has seen four cases of sterile endophthalmitis among 29 patients he has treated with intravitreal Kenalog injections, an incidence of 14%. In comparison, only one patient developed endophthalmitis out of 662 patients he injected with the drug from 2003 to 2005, an incidence rate of 0.15%. Dr. Eaton is an assistant clinical professor at the University of South Florida, as well as a solo practitioner specializing in retina/vitreous.
The four recent cases showed no association with age, gender or amount of inflammation; the only common factor was the use of preserved Kenalog, Dr. Eaton said. He noted that he experienced no such complications with intravitreal injection of other medications.
Additionally, he said, in speaking with other surgeons, he learned that his were not the only cases. Surgeons at Bascom Palmer Eye Institute, for instance, told Dr. Eaton they had experienced nine to 11 such cases, and surgeons as far away as California have reported cases to him as well.
"That showed that it's a more global problem," Dr. Eaton told Ocular Surgery News in an interview at the meeting. "It was quite clear to me that we had a problem."
Philip J. Rosenfeld, MD, PhD, who also attended the meeting here in Naples, said he had never had a case before now, but "it seems that it's happening everywhere."
"We've just been watching these cases, but it's been disturbing," Dr. Rosenfeld said during the discusion period following Dr. Eaton's presentation.
Dr. Eaton has been in contact with the Centers for Disease Control and Prevention, the Food and Drug Administration and Bristol-Myers Squibb. Several cultures and tests have been done in cooperation with the CDC, but the results have so far been inconclusive.
Bristol-Meyers Squibb told Dr. Eaton there has not been any change in its manufacturing of Kenalog and has requested more information from him, Dr. Eaton said.
Until more information about the situation is available, Dr. Eaton advised other retinal specialists to consider using preservative-free triamcinolone from a compounding pharmacy.