Records Show Problems at Steroid Pharmacy as Far Back as '0610/23/12
TUESDAY, Oct. 23 (HealthDay News) -- State records show that the
Massachusetts specialty pharmacy at the epicenter of the nationwide
meningitis outbreak was plagued by problems as far back as 2006,
according to published reports.
The records, which were obtained by the
Associated Pressunder a public documents request, said there
was evidence of inadequate contamination control and no written
standard operating procedures for using equipment, among other
problems, at the New England Compounding Center, the news service
The problems were corrected that year, the
On Monday, a congressional committee asked the Framingham-based
company for records going back a decade.
Also Monday, U.S. health officials reported that 23 people have
now died and 297 have been sickened in the meningitis outbreak
apparently tied to contaminated steroid injections produced at the
company. The latest count found deaths and infections spread across
16 states, according to the U.S. Centers for Disease Control and
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 U.S. Food and Drug
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.
Three of the 297 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 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 FDA. 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.
The CDC on Monday had the following state-by-state breakdown of
cases: Florida: 17 cases, including 3 deaths; Idaho, 1 case;
Illinois, 1 case; Indiana: 40 cases, including 2 deaths; Maryland:
17 cases, including 1 death; Michigan: 62 cases, including 5
deaths; Minnesota: 7 cases; New Hampshire: 10 cases; New Jersey: 16
cases; New York: 1 case; North Carolina: 2 cases, including 1
death; Ohio: 11 cases; Pennsylvania: 1 case; Tennessee: 69 cases,
including 9 deaths; Texas: 1 case; Virginia: 41 cases, including 2
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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