A Florida compounding pharmacy has been linked to a multi-state outbreak of a rare and serious fungal eye infection, according to federal health officials.
The officials confirmed that 33 cases of a rare fungal eye infection spans seven states and originated with products compounded at the same Florida pharmacy responsible for mixing supplements that caused the 2009 deaths of 21 elite polo horses, said the Associated Press (AP).
The patients underwent some sort of an eye procedure—surgery or injections. Of these, 23 suffered vision loss and 24 needed repeat surgery, said the AP, citing a report by the U.S. Centers for Disease Control and Prevention (CDC).
Many cases were traced, by health officials, to a dye and an injection that included triamcinolone and other products that came from Franck’s Compounding Lab in Ocala, Florida, said the AP. The U.S. Food & Drug Administration (FDA) tested unopened bottles and unused syringes of the dye collected from Franck’s Compounding Lab and discovered multiple bacterial and fungal species.
California health officials first alerted the CDC following reports of eye infections in nine patients earlier this year. That alert was followed by Franck’s issuing a March recall of dye lots and a single lot recall of triamcinolone on March 31. Franck’s has neither recalled nor ceased production of other sterile compounded products.
The CDC said it is conducting an investigation and has issued a warning to physicians to avoid “compounded products labeled as sterile from Franck’s,” reported the AP. The FDA is also investigating the matter and has advised that any Brilliant Blue G (BBG) product from Franck’s be quarantined and returned. The FDA stated it received reports of fungal endophthalmitis (eye infections) in patients given BBG supplied by Franck’s Pharmacy during eye surgeries. BBG is not an approved drug in the U.S., noted the FDA. State health officials are unable to confirm if they are conducting an investigation until 10 days after any such alleged probe and, then, only if probable cause is discovered, explained the AP.
Officials at that pharmacy issued a statement indicating that they conducted a thorough investigation, tracing the contamination to a dye used in ocular triamcinolone injections and formulas containing that drug, said the AP. Franck’s also stated it resolved the issue and implemented changes that included hiring a new pharmacist to oversee quality assurance. That pharmacist, Jim Kilbride, RPh, wrote to the FDA and physicians stating that Franck’s recently experienced a fungal issue with one lot of triamcinolone acetonide P.F. 80mg/ml and issued a recall that involved five physicians and eight prescriptions. The letter also discussed another recall of triamcinolone acetonide P.F. 80mg/ml and stated that no adverse events have been reported related to that lot, which involved four physicians and five prescriptions.
Meanwhile, Franck’s acknowledged it used excess selenium in a veterinarian-prescribed supplement mix that causes the death of the 21 horses; the horses’ owners have since filed a lawsuit, said the AP. The FDA accused Franck’s of illegally developing copies of similar drugs, of creating so-called “brews” outside of federal guidelines, and compounding animal products from drugs not approved for use in the U.S. The FDA, said the AP, said Franck’s was warned in 2005 and, again, in 2009, for illegal animal drug compounding. In 2011, a federal court disagreed, finding that the FDA had no jurisdiction over the established pharmaceutical practice of filling veterinary prescriptions for animals via compounding from bulk substances, said the AP.
Compounding involves mixing drugs using bulk ingredients, typically when patients are allergic to inactive ingredients in medicines approved by the FDA or when a different dose or delivery form (cream, powder, injectable) is needed and cannot be commercially filled, said the AP. Pharmacies are able to work outside of the statutory drug approval process by creating drugs via pharmacy compounding.