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
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 August 31.
The CDC has said it learned about the fungal meningitis
outbreak on September 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.
"We are finding a fair amount of toxicity," Dr. Carol
Kauffman, infectious diseases chief at the University of Michigan Health
System, said during an infectious disease and epidemiology conference
in San Diego. "We don't want to have 80-year-olds hallucinating. That's
indeed what is happening."
CONTRACTS UNDER SCRUTINY
NECC is under investigation by federal authorities over
how it supplied hospitals, clinics and other healthcare providers with
large orders of drugs, including whether it violated state laws
regulating pharmacies.
U.S. Senator
Richard Blumenthal Of Connecticut, who previously called for a criminal
investigation of NECC, raised new questions on Thursday about a
government contract for medications from NECC's sister company,
Ameridose.
In a letter to the U.S. Department of Defense, he cited
a July purchase agreement for specialized medicines between the U.S.
Army Medical Command and Ameridose. They were intended for use in the
neonatal intensive care unit at the Army's Tripler Medical Center in
Honolulu.
Most of the meningitis cases have been linked to
Exserohilum, a fungus associated with grass and rotting wood that
appears to be especially aggressive in attacking tissues in the spine
and brain stem.
Fungal infections typically only attack people with
severely compromised immune systems, such as patients who have had bone
marrow or organ transplants.
In the case described by the team at Johns Hopkins, the
injection was the woman's first and she had no medical history of
having a compromised immune system, nor was she taking any long-term
medications.
Doctors found nothing and sent her home, but the woman
returned the next day with more severe symptoms and was admitted to the
hospital, where she was treated with a series of antibiotics and other
drugs.
Tests for a host of
infections were all negative. The woman died 10 days after being
admitted to the hospital, the same day the team found evidence of
Exserohilum in her spinal fluid. An autopsy showed massive tissue death
in the brain stem, inflammation in the blood vessels and evidence of a
stroke.
Based on the case,
the researchers urged doctors to be aware of the symptoms of fungal
meningitis and to seek rapid diagnosis and treatment to prevent "serious
complications and deaths."
The CDC advises
patients who feel ill and are concerned they were injected with one of
the recalled products to contact their physicians.
On a call with
healthcare providers earlier this week, the CDC said the typical
incubation period was one to four weeks after injection, but that it
could be two months or longer.
"We want you to remain vigilant for several months after injection," Chiller told physicians.
Symptoms of fungal
meningitis include new or worsening headache, fever, sensitivity to
light, stiff neck, weakness or numbness in any part of the body, slurred
speech, increased pain, redness or swelling at the injection site.
Here is the full release from Rockingham County Sheriff Bryan F. Hutcheson:
