NEW YORK (WKOW) -- Health officials say the number of
people sickened by a deadly meningitis outbreak is rising. There are now 47
cases in seven states.
Five people have died.
Tennessee, Virginia, Maryland, Florida, North Carolina and
Indiana had previously reported cases. On Friday, Michigan joined the list, with
four cases.
The outbreak of fungal meningitis has been tied to steroid
shots used to treat back pain. The steroid was custom-made by a specialty
pharmacy in Massachusetts. Health inspectors found fungus in at least one sealed
vial of the steroid at the company's facility.
The company has recalled the steroid which was sent to
clinics in 23 states. The government is urging doctors not to use any of the
company's products.
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NEW YORK (AP) - Health providers are scrambling to notify
patients in nearly two dozen states that steroid shots they got for back pain
may have been contaminated with a fungus tied to a deadly meningitis
outbreak.
It became apparent Thursday that hundreds, and perhaps
thousands, of people who got the shots between July and September could be at
risk. Officials disclosed that a steroid suspected in the fungal meningitis
outbreak in the South had made its way to 75 clinics in 23 states.
The Food and Drug Administration urged physicians not to
use any products at all from the Massachusetts specialty pharmacy that supplied
the steroid.
On Friday, the FDA released a list of about 30 medications
distributed by the company, including other steroids, anesthetics and blood
pressure medicine.
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 received steroid shots for back pain, a highly
common treatment.
It is not clear how many patients received tainted
injections, or even whether everyone who got one will get sick. 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.
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,
Massachusetts health officials said.
Investigators this week found contamination in a sealed
vial of the steroid at the company, FDA officials said. Tests are under way to
determine if it is the same fungus blamed in the outbreak.
Several hundred of the vials, maybe more, have been
returned unused, but many others were used. At one clinic in Evansville, Ind.,
more than 500 patients received shots from the suspect lots, officials said. At
two clinics in Tennessee, more than 900 patients - perhaps many more - did.
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.
Massachusetts health officials said the company has a
pending complaint against it from this year, related to the potency of a
medication used in eye surgery. It appears unrelated to the current outbreak,
said Dr. Madeleine Biondolillo, director of the state's Bureau of Healthcare
Safety.
Biondolillo said two prior complaints, including one for
sterile compounding procedures, were both resolved in 2006. The pharmacy was
inspected and cleared by the state Department of Public Health last year after
relocating its operations on the same site, she said.
The first known case in the meningitis outbreak was
diagnosed about two weeks ago in Tennessee, which still 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 that's widespread but very
rarely causes illness. It 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 company that supplied the steroid 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.
New England Compounding Center 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."
___
Associated Press writers Travis Loller in Nashville, Jay
Lindsay in Boston, Randall Chase in Wilmington, Del., and AP chief medical
writer Marilynn Marchione in Milwaukee contributed to this story.
___
Online:
Recalled list: http://www.fda.gov/Drugs/DrugSafety/ucm322752.htm
CDC: http://www.cdc.gov/meningitis/fungal.html
