* 12 more meningitis cases bring total to 294
* Cautions over NECC drugs injected since May 21
By Bill Berkrot
Oct 22 The extended shutdown of a sister company
of the pharmacy at the center of the deadly U.S. meningitis
outbreak may exacerbate drug shortages for some hospitals and
healthcare providers as the number of infection cases neared
300, U.S. health regulators said.
Ameridose, a drug manufacturer owned by the same people who
own New England Compounding Center, or NECC, has been closed
since Oct. 10. It will remain shuttered until Nov. 5 while
authorities inspect the plant, at least temporarily cutting off
supplies to its customers.
NECC shipped thousands of potentially contaminated vials of
a steroid used for injections to treat severe back pain. Some
14,000 patients may have been exposed to the medicine that has
so far led to 23 deaths.
Twelve additional fungal meningitis cases were reported on
Monday, bringing the total to 294 in 16 states, plus three cases
of peripheral joint infection likely linked to the tainted
steroid, according to the U.S. Centers for Disease Control and
Prevention. No additional deaths were reported.
Nine of the new cases were reported in Michigan, which has
reported 63 infections and five deaths. Tennessee has been
hardest hit, with 69 reported cases and nine deaths.
Two more have been reported in Indiana, and one in Maryland,
the CDC said.
Congressional investigators said on Monday that federal and
state health regulators knew of potential problems with NECC
steroid treatments as early as 2002, when officials began
inspecting NECC's facility after the report of an adverse health
event linked to the drug.
All NECC products have been recalled, but no Ameridose
products have been linked to meningitis or faced recall. NECC
and Ameridose are based in the suburbs of Boston.
On Monday, the U.S. Food and Drug Administration provided on
its website a list of all customers who received NECC products
on or after May 21.
Although only the steroid methylprednisolone has been
confirmed as contaminated thus far, the FDA has recommended that
healthcare professionals follow up with any patients who were
administered any injectable product shipped by NECC on or after
May 21, including drugs for eyes or cardioplegic solution used
in open heart surgery. It said patients should remain vigilant
for any signs of infection and contact physicians if they are
Symptoms of fungal meningitis include fever, headache, stiff
neck, nausea, sensitivity to light, slurred speech and changes
in mental function.
The FDA posted a statement on its website on Saturday saying
the production shutdown of Ameridose might affect supplies of
"certain drugs for some health care systems." It said it was
working with Ameridose to ensure that its drugs are safe.
The agency directed hospitals and clinics to its drug
shortage website for information on the availability of drugs
that are in short supply. It did not, however, identify which
drugs or healthcare systems were being affected by the lack of
NECC is being investigated by federal and state authorities
to determine if it violated compounding pharmacy regulations by
supplying large orders of medicines without matching its drugs
to specific prescriptions for patients or treatment regimens. It
is also facing a raft of lawsuits connected to the meningitis
Although the typical incubation period for contracting
fungal meningitis from the tainted steroid is one to four weeks
after injection, it can be far longer. Doctors have been
cautioned to monitor patients for signs of meningitis for
several months after they received injections.
Rapid treatment with a powerful antifungal drug is
considered crucial to prevent the infection from spreading to
the brain, where it has caused strokes and other damage.
Patients who received injections of NECC drugs before May 21
and who have not had infection symptoms are considered to be at
less risk because of the time that has elapsed, the FDA said.
Patient follow-up was not recommended for those who received
non-injected NECC products such as lotions and eye drops, which
are considered to be low risk.