New Warnings in Fungal Meningitis Outbreak
Oct. 15, 2012 -- More patients -- not just those who got steroid shots -- will be getting calls from their doctors warning them they might have a dangerous fungal infection.
The FDA now suspects fungal contamination is possible in all of the supposedly sterile products made by the New England Compounding Pharmacy (NECC) on or after May 21, 2012. People who got shots of any of these medicines -- particularly those given during eye treatments or heart surgery -- are at risk.
There's already one possible case of fungal meningitis in a patient who received a different NECC steroid product (triamcinolone acetonide) than the three lots of methylprednisolone known to have infected patients.
Two people who received an NECC heart medication during transplant surgeries have fungal infections. The heart drug is called cardioplegic solution and is used to temporarily stop the heart during open heart surgery. [EDITOR'S NOTE: On Oct. 16, the FDA revised the report. Only one patient with a fungal infection had received the NECC solution.]
It's not clear whether those infections came from the NECC drug or something else. So far, there have been no reported cases of eye infections linked to NECC products.
"At this point in FDA’s investigation, the sterility of any injectable drugs, including ophthalmic drugs that are injectable or used in conjunction with eye surgery, and cardioplegic solutions produced by NECC, are of significant concern, and out of an abundance of caution, patients who received these products should be alerted to the potential risk of infection," the FDA today warned in a statement.
The CDC now has two reports of fungal infections in patients who received NECC steroid shots in the knee, hip, shoulder, or elbow.
Including these cases, 214 people in 15 states got fungal infections traced to NECC products. Fifteen patients have died.
Today's warning applies only to sterile drugs delivered by injections. "At this time," the FDA notes, the warning does not include NECC products applied as lotions, creams, eye drops, or suppositories. Before shutting down operations, the NECC offered more than 2,100 different products for sale in all 50 states.
The FDA advises doctors that they may get a lot of calls from patients and to use their judgment about who is at risk.