Date: Fri 5 Oct 2012
Source: NBC News, Associated Press (AP) report [edited]
potential scope of the meningitis outbreak that has killed at least 5
people widened dramatically Thu 4 Oct 2012, 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 FDA 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.
far, 35 people in 6 states -- Tennessee (25), Virginia (4), Maryland
(2), Florida (2), North Carolina (1) and Indiana (1) -- have contracted
fungal meningitis, and 5 of them have died, according to the CDC. All
had received steroid shots for back pain, a highly common treatment.
an alarming indication the outbreak could get a lot bigger,
Massachusetts health officials said the pharmacy involved, the New
England Compounding Center [NECC] of Framingham, MA, has recalled 3 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
2012 and September 2012, federal health officials said. Several hundred
of the vials, maybe more, have been returned unused, a Massachusetts
But many other vials were used. At a
clinic in Evansville, Indiana, more than 500 patients got injections
from the suspect lots, officials said. At 2 clinics in Tennessee, more
than 900 patients, perhaps many more, did.
investigation began about 2 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.
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.
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. The common mold _Aspergillus_ was cultured
from 5 patients, the CDC said Thursday [4 Oct 2012].
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. Compounding
pharmacies are not regulated as closely as drug manufacturers, and
their products are not subject to FDA approval.
national shortage of many drugs has forced doctors to seek custom-made
alternatives from compounding pharmacies. 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
The company said in a statement Thursday
[4 Oct 2012] 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.
[Byline: Mike Stobbe]