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| A sign requesting "No Soliciting" hangs on the door of New England Compounding in Framingham, Mass., Thursday, Oct. 4, 2012. An outbreak of a rare and deadly form of fungal meningitis that has killed 4 people and sickened another 26 in five states is believed to have been traced back to a steroid manufactured by the New England Compounding Center. |
NEW YORK (AP) -- The potential scope of the meningitis outbreak that has killed at least five people widened dramatically Thursday as health officials warned that hundreds, perhaps thousands, of patients who got steroid back injections in 23 states could be at risk.
Clinics
and medical centers rushed to contact patients who may have received
the apparently fungus-contaminated shots. And the Food and Drug
Administration urged doctors not to use any products at all from the
Massachusetts pharmacy that supplied the suspect steroid solution.
It is not clear how many patients received tainted injections, or even whether everyone who got one will get sick.
So
far, 35 people in six states - Tennessee, Virginia, Maryland, Florida,
North Carolina and Indiana - have contracted fungal meningitis, and five
of them have died, according to the Centers for Disease Control and
Prevention. All had received steroid shots for back pain, a highly
common treatment.
In an alarming indication
the outbreak could get a lot bigger, Massachusetts health officials said
the pharmacy involved, the New England Compounding Center of
Framingham, Mass., has recalled three lots consisting of a total of
17,676 single-dose vials of the steroid, preservative-free
methylprednisolone acetate.
An unknown number
of those vials reached 75 clinics and other facilities in 23 states
between July and September, federal health officials said. Several
hundred of the vials, maybe more, have been returned unused, one
Massachusetts official said.
But many other
vials were used. At one clinic in Evansville, Ind., more than 500
patients got shots from the suspect lots, officials said. At two clinics
in Tennessee, more than 900 patients - perhaps many more - did.
The
investigation began about two weeks ago after a case was diagnosed in
Tennessee. The time from infection to onset of symptoms is anywhere from
a few days to a month, so the number of people stricken could rise.
Investigators
this week found contamination in a sealed vial of the steroid at the
New England company, according to FDA officials. Tests are under way to
determine if it is the same fungus blamed in the outbreak.
The company has shut down operations and said it is working with regulators to identify the source of the infection.
"Out
of an abundance of caution, we advise all health care practitioners not
to use any product" from the company, said Ilisa Bernstein, director of
compliance for the FDA's Center for Drug Evaluation and Research.
Tennessee has by far the most cases with 25, including three deaths. Deaths have also been reported in Virginia and Maryland.
Meningitis
is an inflammation of the lining of the brain and spinal cord. Symptoms
include severe headache, nausea, dizziness and fever.
The
type of fungal meningitis involved is not contagious like the more
common forms. It is caused by a fungus often found in leaf mold and is
treated with high-dose antifungal medications, usually given
intravenously in a hospital.
Robert Cherry,
71, a patient who received a steroid shot at a clinic in Berlin, Md.,
about a month ago, went back Thursday morning after hearing it had
received some of the tainted medicine.
"So
far, I haven't had any symptoms ... but I just wanted to double check
with them," Cherry said. "They told me to check my temperature and if I
have any symptoms, I should report straight to the emergency room, and
that's what I'll do."
The New England company
is what is known as a compounding pharmacy. These pharmacies custom-mix
solutions, creams and other medications in doses or in forms that
generally aren't commercially available.
Other
compounding pharmacies have been blamed in recent years for serious and
sometimes deadly outbreaks caused by contaminated medicines.
Two
people were blinded in Washington, D.C., in 2005. Three died in
Virginia in 2006 and three more in Oregon the following year. Twenty-one
polo horses died in Florida in 2009. Earlier this year, 33 people in
seven states developed fungal eye infections.
Compounding pharmacies are not regulated as closely as drug manufacturers, and their products are not subject to FDA approval.
A
national shortage of many drugs has forced doctors to seek custom-made
alternatives from compounding pharmacies. The steroid suspected in the
outbreak has been in short supply.
The New
England company at the center of the outbreak makes dozens of other
medical products, state officials said. But neither the company nor
health officials would identify them.
The
company said in a statement Thursday that despite the FDA warning,
"there is no indication of any potential issues with other products." It
called the deaths and illnesses tragic and added: "The thoughts and
prayers of everyone employed by NECC are with those who have been
affected."
A 2011 state inspection of the Framingham facility gave the business a clean bill of health.
