TUESDAY, Oct. 23 (HealthDay News) -- Massachusetts officials
said Tuesday that they have launched a criminal investigation into
the specialty pharmacy at the center of the fungal meningitis
outbreak that has now sickened 308 people in 17 states and killed
Gov. Deval Patrick said the state has also moved to revoke the
license of the New England Compounding Center,
State inspectors said they found unsanitary conditions that
included black specks of fungus in steroids made at the
Framingham-based company, the network said.
The inspectors' preliminary investigation also revealed that the
company distributed drugs before the return of tests to check for
sterility. They added that the company functioned as a drug
manufacturer, producing drugs for broad use, rather than filling
individual prescriptions for individual doctors, in violation of
its state license,
The network also said the inspectors found dirty floor mats, a
leaky boiler, inadequate sterilization of medications and improper
testing of laboratory equipment.
The company said it was cooperating with investigators,
According to published reports, state records showed that the
New England Compounding Center was plagued by problems as far back
Those records, obtained by the
Associated Pressunder a public documents request, showed
there was evidence of inadequate contamination control and no
written standard operating procedures for using equipment, among
other problems, at the facility.
Those problems were corrected that year, the network
The New England Compounding Center is what's known as a
compounding pharmacy. These pharmacies combine, mix or alter
ingredients to create specific drugs to meet the specific needs of
individual patients, according to the U.S. Food and Drug
Administration. Such customized drugs are frequently required to
fill special needs, such as a smaller dose, or the removal of an
ingredient that might trigger an allergy in a patient.
As of Tuesday, U.S. health officials reported that cases linked
to the fungal meningitis outbreak have risen to 308, with the
number of deaths unchanged at 23. The latest count found deaths and
infections spread across 17 states, according to the U.S. Centers
for Disease Control and Prevention.
Meningitis is a potentially fatal inflammation of the lining
surrounding the brain and spinal cord.
Federal health officials said last week that fungus found in
steroid injections produced by the company matched the fungus
linked to the meningitis outbreak. The officials said they'd
confirmed the presence of the fungus,
Exserohilum rostratum, in unopened vials of a steroid
produced by the New England Compounding Center.
The vial came from one of three lots recalled by the company
last month, officials from the CDC and the FDA said.
The steroid, methylprednisolone acetate, is injected into
patients for back and joint pain. The company has since shut down
operations and stopped distributing its products, health officials
The CDC and state health departments estimate that roughly
14,000 patients may have gotten steroid injections from the three
lots, and nearly 97 percent of them have been contacted for medical
All of the fungal meningitis patients identified so far were
thought to be injected with methylprednisolone acetate from the
Massachusetts pharmacy, according to the CDC.
Four of the 308 cases involve what the CDC calls "peripheral
joint infection," meaning an infection in a knee, hip, shoulder or
elbow. These joint infections aren't considered as dangerous as
injections near the spine for back pain that have been linked to
the potentially fatal meningitis infections.
The FDA said it was advising all health care professionals to
follow up with any patients who were given any injectable drug from
or produced by the New England Compounding Center. These drugs
include medications used in eye surgery, and a heart solution
purchased from or produced by the company after May 21.
The CDC on Tuesday had the following state-by-state breakdown of
cases: Florida: 19 cases, including 3 deaths; Georgia, 1 case;
Idaho, 1 case; Illinois, 1 case; Indiana: 40 cases, including 2
deaths; Maryland: 17 cases, including 1 death; Michigan: 68 cases,
including 5 deaths; Minnesota: 7 cases; New Hampshire: 10 cases;
New Jersey: 17 cases; New York: 1 case; North Carolina: 2 cases,
including 1 death; Ohio: 11 cases; Pennsylvania: 1 case; Tennessee:
70 cases, including 9 deaths; Texas: 1 case; Virginia: 41 cases,
including 2 deaths.
Health officials said they expect to see more cases of the rare
type of meningitis, which is not contagious, because symptoms can
take a month or more to appear.
Infected patients have developed a range of symptoms
approximately one to four weeks following their injection. People
who have had a steroid injection since July, and have any of the
following symptoms, should talk to their doctor as soon as
possible: worsening headache, fever, sensitivity to light, stiff
neck, new weakness or numbness in any part of your body or slurred
speech, the CDC said.
Infected patients must receive intravenous drugs in a
Compounding pharmacies aren't subject to the same FDA oversight
as regular drug manufacturers are, and some members of Congress now
say the meningitis outbreak highlights the need for more regulatory
The U.S. National Library of Medicine has more about
injections for back pain.
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