Fungal contamination may be in all drugs made New England Compounding Pharmacy after 5/21.
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.
2 more drugs implicated in fungal meningitis outbreak, US health officials say
Two more drugs have been implicated in the ongoing outbreak of fungal meningitis linked to contaminated pain injections, federal health officials said Monday.
Both come from the same pharmacy, New England Compounding Center, that distributed the steroids suspected of sickening at least 214 people and killing 15 of them, the Food and Drug Administrationsaid in a statement.
One is a steroid called triamcinolone acetonide and another is a product used during heart surgery. While the FDA hasn’t confirmed that the two products are to blame, it’s issued a warning.
Federal regulators broadened their warning to doctors Monday, raising questions about the potential risk of infection from other injectable drugs made by the specialty pharmacy in Massachusetts linked to the burgeoning fungal-meningitis outbreak.
The Food and Drug Administration said it received reports of three new cases of infections tied to two additional products made by the New England Compounding Center (NECC). One involves the steroid triamcinolone acetonide, which is different from the steroid implicated in the existing meningitis cases. A patient who may now have meningitis received an epidural of the medication, the FDA said.
The other two cases involve a medication that is injected into the coronary arteries to temporarily paralyze the heart during open-heart and transplant surgery. Two patients who received the medication, called cardioplegic solution, during heart-transplant surgery, subsequently developed fungal infections, the agency said.
As a result of the cases, the sterility of any injectable drugs made by the NECC, including ones used in eye and heart surgery, “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 agency said in a statement posted on its Web site.
Fungus infections from Aspergillis, one fungus linked to the meningitis outbreak, were reported in two transplant patients who received cardioplegic solution from NECC, the FDA said. Cardioplegic solution is used to induce paralysis of the heart during open-heart surgery.
The other fungus linked to the meningitis outbreak is Exserohilum, which the CDC says may not be easily detectable. A patient with a negative fungal test is not in the clear, officials have said.
Meningitis outbreak spreads to 15 states, 214 cases