FDA finds fungus in steroid shots, meningitis toll rises
By Bill Berkrot and Deena Beasley ,Reuters
October 20, 2012, 12:06 am TWN
NEW YORK/LOS ANGELES -- U.S. health officials made their first confirmation of the presence of a deadly fungus in one of three lots of steroids tied to a national meningitis outbreak as the death toll rose to 20 on Thursday.
The U.S. Food and Drug Administration (FDA) said it was still testing two additional lots of methylprednisolone acetate, the steroid used to treat back pain, for the presence of the rare Exserohilum fungus. It is also testing other injectable drugs that were supplied by the New England Compounding Center, or NECC, in Massachusetts.
“Now we can definitively say that the injections are linked to the infection,” Dr. Tom Chiller, an epidemiologist with the U.S. Centers for Disease Control and Prevention, told Reuters in an interview. “To date, CDC has no firm evidence of infection in any patients beyond those exposed to the contaminated lots.”
THE CDC said the death toll climbed by one to 20, while nine new cases brought the national total to 254, including the first in New York — the 16th state with confirmed infections.
Michigan reported its fourth fungal meningitis death and new cases were also reported in Indiana, New Hampshire, New Jersey, Ohio and Tennessee. There are also three cases of peripheral infections in joints, the CDC said.
“There were a lot more spinal injections performed versus joint injections, but the infection rate may also reflect the fact that joint infections might be slower or the incubation period could be longer ... we just don't know,” Chiller said.
About 14,000 patients are believed to have been exposed to the potentially tainted NECC steroid and some 97 percent of them have been contacted so far, the FDA and CDC said.
NECC issued a statement saying it was “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.”
U.S. doctors in Baltimore said early diagnosis and treatment of patients at risk of fungal meningitis was vital, based on the case of an otherwise healthy woman who declined rapidly after receiving steroid injections for neck pain.
Writing in the Annals of Internal Medicine, researchers at the Johns Hopkins School of Medicine described the deterioration of an unidentified 51-year-old who sought care in an emergency room for a severe headache a week after receiving an injection with tainted medication on Aug. 31.
The CDC has said it learned about the fungal meningitis outbreak on Sept. 21 and that it contacted patients injected as far back as May.
Patients found to be infected are treated with a fairly high dose of voriconazole, sold by Pfizer Inc under the brand name Vfend, which can cause side effects including “visual disturbances,” fever and headache.