Federal regulators Thursday said they have confirmed the presence of a fungus in unopened vials of steroids from the troubled Framingham pharmacy at the center of a nationwide meningitis outbreak that matches the type of infection found in most of the sick patients.
The US Centers for Disease Control and Prevention said in a statement that it found a fungus known as Exserohilum rostratum in unopened vials of the steroid methylprednisolone acetate shipped by New England Compounding Center. The vials were among more than 17,000 doses of the injectable steroid contained in three suspect lots sent to clinics in 23 states.
A spokesman for the US Food and Drug Administration, Sarah Clark-Lynn, said in an e-mail that the “majority of vials” from the first lot tested exhibited fungal growth, meaning the contamination was not an isolated incident. She said the CDC used genetic testing to confirm the presence of Exserohilum rostratum, but did not say how many vials were found to contain this fungus.
As of Wednesday, all but two of the meningitis patients with laboratory-confirmed cases had been infected with Exserohilum, the CDC said.
Previously, health officials had said they found fungus in a single vial of steroid from New England Compounding, but they had not pinpointed the type. Thursday’s announcement more closely ties the pharmacy to the outbreak.
“The laboratory confirmation further links steroid injections from these lots from NECC to the multistate outbreak of fungal meningitis and joint infections,” the CDC statement said. “Testing on the other two implicated lots of methylprednisolone acetate and other NECC injectables continues.”
New England Compounding released a statement Thursday afternoon:
“We are eager to review these findings as part of our continued cooperation with the CDC and FDA to identify the cause of this contamination. The CDC and FDA have previously confirmed infections linked to cases of fungal meningitis in patients who received injections of methylprednisolone acetate. NECC is earnestly focused on determining, along with these agencies, the cause of contamination in vials of this product – and to rapidly and professionally carry out a recall to remove all NECC products from circulation. We urge anyone with questions or concerns to dial FDA’s Drug Information Line at 855-543-DRUG (3784) and press * to get the most recent information regarding the recall and speak directly to a pharmacist.”
Federal health officials estimate that approximately 14,000 patients may have received injections with medication from the three implicated lots of methylprednisolone between May 21 and Sept. 26, when the steroid was recalled. They said nearly 97 percent of these patients have been contacted for further follow-up.
Patients received the injectable steroid to treat back and joint pain. To date, 257 people nationwide have been sickened in the outbreak, mostly with meningitis but also some with joint infections, the CDC said Thursday. Twenty people have died. New Hampshire is the only New England state with reported cases, with eight.