THURSDAY, Nov. 1 (HealthDay News) -- Lab tests have found
bacteria in two other medical products made by the
Massachusetts-based specialty pharmacy at the center of an ongoing
fungal meningitis outbreak, U.S. Food and Drug Administration
officials said Thursday.
Just how dangerous the various bacteria found in three batches
of a steroid used during eye surgery and one batch of a solution
used to stop the heart during cardiac surgery might be is not yet
clear, FDA officials said in a news release.
However, tests for fungal contamination in both products are
pending and FDA officials reiterated their concern about the safety
of any medical products made by the New England Compounding Center.
Since the meningitis outbreak began, the company has recalled all
of its medical products and shut down its manufacturing plant in
FDA officials said several types of bacillus bacteria were found
in three lots of preservative-free betamethasone, with each lot
producing different culture results, and in a single lot of
cardioplegia solution. The bacteria found included
Meanwhile, the state of Massachusetts on Thursday said it has
put emergency regulations in place that give the state greater
control and scrutiny over specialty pharmacies such as the New
England Compounding Center, the
Under the new rules, the state can now track the volume and
distribution of drugs made by these pharmacies to see if they
should be subject to FDA licensing regulations, the
Globereported. Pharmacies that fail to follow the stricter
state regulations will be subject to penalties that include being
shut down or quarantined by the state pharmacy board, and specialty
pharmacies will also have to report when they are being
investigated by another state or federal agency, according to the
As of Thursday, 28 people have died and 386 have been sickened
in the fungal meningitis outbreak, federal health officials
Infections have been reported in 19 states. Virginia initially
reported three deaths tied to the outbreak, but reduced it to two
deaths on Thursday, the U.S. Centers for Disease Control and
The CDC had the following state-by-state breakdown of cases:
Florida: 23 cases, including 3 deaths; Georgia, 1 case; Idaho, 1
case; Illinois, 1 case; Indiana: 48 cases, including 3 deaths;
Maryland: 22 cases, including 1 death; Michigan: 106 cases,
including 7 deaths; Minnesota: 10 cases; New Hampshire: 11 cases;
New Jersey: 18 cases; New York: 1 case; North Carolina: 3 cases,
including 1 death; Ohio: 15 cases; Pennsylvania: 1 case; Rhode
Island: 2 cases; South Carolina: 1 case; Tennessee: 75 cases,
including 11 deaths; Texas: 1 case; Virginia: 46 cases, including 2
Nine of the 386 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.
Meningitis is inflammation of the lining surrounding the brain
and spinal cord. The steroid injections are used to treat pain in
the lower back as well as joints.
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.
The CDC and state health departments estimate that roughly
14,000 patients may have gotten steroid injections from the New
England Compounding Center. All of the fungal meningitis patients
identified so far were thought to be injected with
methylprednisolone acetate, according to the CDC.
Massachusetts officials have begun a criminal investigation into
the specialty pharmacy.
Federal investigators said last Friday that a tour of the
Framingham plant found foreign, "greenish-black" material in some
vials of the injectable steroid suspected as the cause of the
illnesses. The contaminated product was one of a host of potential
violations discovered during a recent inspection of the New England
Compounding Center's plant.
On Wednesday, the U.S. Food and Drug Administration said that a
company with the same founders as the New England Compounding
Center was voluntarily recalling all of its products.
"Ameridose LLC, based in Westborough, Mass., is voluntarily recalling all of its unexpired products in circulation," the FDA said in a statement.
"The FDA is currently conducting an inspection of Ameridose's facility," the agency said. "Although this inspection is ongoing, the FDA's preliminary findings have raised concerns about a lack of sterility assurance for products produced at and distributed by this facility."
While the FDA said there have been no reports of infections
linked to Ameridose products, the agency recommended the recall
"out of an abundance of caution."
"Health care professionals and patients may dial the FDA's Drug Information Line at 855-543-DRUG  and press [the star sign] to get the most recent information regarding the Ameridose recall and speak directly to a pharmacist," the agency added.
The New England Compounding Center is what's known as a
compounding pharmacy. These pharmacies combine, mix or alter
ingredients to create 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.
Compounding pharmacies aren't subject to the same FDA oversight
as regular drug manufacturers are, but 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.
Please be aware that this information is provided to supplement the care provided by your physician. It is neither intended nor implied to be a substitute for professional medical advice. CALL YOUR HEALTHCARE PROVIDER IMMEDIATELY IF YOU THINK YOU MAY HAVE A MEDICAL EMERGENCY. Always seek the advice of your physician or other qualified health provider prior to starting any new treatment or with any questions you may have regarding a medical condition.
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