THURSDAY, Oct. 11 (HealthDay News) -- Twelve people have now
died and 137 have been sickened in the national meningitis outbreak
apparently linked to contaminated steroid injections, U.S. health
officials reported Wednesday.
In the wake of the outbreak, members of Congress are calling for
more regulatory oversight of the type of smaller, "compounding"
pharmacy that distributed the steroid shots. And new information
about the regulatory history of the company tied to the outbreak
has begun to emerge.
All of the patients affected were thought to be injected with
methylprednisolone acetate, a steroid drug commonly used for back
pain that investigators suspect was tainted with a fungus usually
found in leaf mold, according to the U.S. Centers for Disease
Control and Prevention.
Health officials in the 23 states that received shipments of the
steroid are trying to track down patients who got the injections.
As many as 13,000 people may have gotten the shots, U.S. health
officials have said.
The steroid was manufactured by a specialty pharmacy, New
England Compounding Center of Framingham, Mass., which last month
voluntarily recalled three lots of the steroid. It has since shut
down operations and stopped distributing its products, health
According to story Thursday by the
Associated Press, this is not the first time New England
Compounding Center has encountered problems with contaminated
vaccines. In 2007, the company settled a lawsuit that claimed that
an 83-year-old man died in 2004 after contracting fatal bacterial
meningitis from a shot produced by the compounding center. The
pharmacy reached a settlement with the man's widow before the case
went to trial, the
Another company, Ameridose, based in Westborough, Mass., has the
same owners as New England Compounding Center and voluntarily shut
down Wednesday for inspections. According to the
AP, a business customer had recently complained that
Ameridose neglected to separate sterile and non-sterile products it
The New York Times, New England Compounding Center is
relatively small, with 49 employees. Compounding pharmacies are not
subject to the same oversight from the U.S. Food and Drug
Administration as regular drug stores are, and members of Congress
now say the outbreak points to a need for more regulatory
"This incident raises serious concerns about the scope of the practice of pharmacy compounding in the United States and the current patchwork of federal and state laws," according to a statement by Rep. Henry Waxman, (D-Calif.) and two other Democrats on the House Energy and Commerce Committee, Rep. Diana DeGette of Colorado and Rep. Frank Pallone Jr. of New Jersey, the Timesreported.
Republicans form the majority on the committee, but a
spokeswoman for Republican committee chair Fred Upton of Michigan,
Timesthat he and three other Republican members would join a
request for an inquiry.
And Rep. Edward Markey, a Massachusetts Democrat who represents
the district that's home to New England Compounding Center, said he
would push for legislation that requires certain pharmacies that
distribute products across state lines to register with the
According to the
Associated Press, it is still not known how many of the
steroid shots were contaminated with the fungus that causes this
rare type of meningitis, so it's not clear how many people might be
at risk of infection.
The 13,000 figure includes not only people who got the shots for
back pain and are considered most at risk, because meningitis is
inflammation of tissue surrounding the brain and spinal cord. Other
patients got injections in other parts of the body, such as knees
There was no breakdown on the number of back injections, said
Curtis Allen, a spokesman for the CDC.
On Wednesday, the CDC offered the following state-by-state
breakdown of cases: Florida: 6 cases, including 1 death; Indiana:
15 cases; Maryland: 9 cases, including 1 death; Michigan: 28 cases,
including 3 deaths; Minnesota: 3 cases; New Jersey: 2 cases; North
Carolina: 2 cases; Ohio: 1 case; Tennessee: 44 cases, including 6
deaths; Virginia: 27 cases, including 1 death.
The CDC last week released a list of the approximately
75 health-care facilities that received contaminated
U.S. 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.
All of the infected patients are thought to have received the
medication from the Massachusetts pharmacy, said Dr. Benjamin Park,
a medical officer with the CDC's National Center for Emerging and
Zoonotic Infectious Diseases.
Infected patients have developed a variety of symptoms
approximately one to four weeks following their injection. Symptoms
include fever, new or worsening headache, nausea, and "new
neurological deficit [consistent with deep brain stroke]," the CDC
said in a news release. Some of these patients' symptoms were very
mild in nature. Cerebrospinal fluid from these patients has shown
findings consistent with meningitis, the agency said.
Doctors should immediately contact patients who have had an
injection from any of the three lots to see if they're having any
symptoms, the CDC said.
Although all cases of meningitis detected so far occurred after
injections with products from these three lots, the CDC and the FDA
recommended, "out of an abundance of caution," that health-care
professionals not use any products produced by the New England
Compounding Center until more information is available.
Patients 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, slurred
The steroid injection procedure -- called lumbar epidural
steroid injection -- is a common treatment for back pain that has
not responded to medicines, physical therapy or other nonsurgical
"From the time of the injection until symptoms appear may be a month or more," Dr. William Schaffner, an infectious disease expert at Vanderbilt University Medical Center in Nashville, told HealthDay.
He added that not everyone who got the steroid injection will
develop meningitis, but it's hard to know how many will.
Infected patients must receive intravenous drugs in a hospital
setting, added Dr. Pascal James Imperato, a dean at the School of
Public Health of SUNY Downstate Medical Center in New York
Treatment can take weeks if not months, because these infections
are difficult to treat, Schaffner explained. And the drugs can have
severe side effects, including affecting kidney function, he
Although the steroid is the primary target of investigation,
health officials haven't ruled out the antiseptic and anesthetic
used during the injections as a possible cause of the outbreak,
The U.S. National Library of Medicine has more about
injections for back pain.
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