
The nationwide response to a rare outbreak of fungal meningitis
is becoming more urgent. Now, the U.S. Food and Drug
Administration (FDA) is advising healthcare professionals to
follow-up with patients who were administered any product
purchased from or produced by New England Compounding Pharmacy (NECC)
in Framingham, Mass., after May 21, 2012. Contaminated epidural
steroid injections are thought to be at the root of the outbreak
that, as of Oct. 18, 2012, has sickened 257 people with at least
20 dying as a result.
DPH epidemiologists are working to notify about 150 facilities
in Georgia that received shipments of any product from NECC. The
expanded warning from FDA includes an ophthalmic drug that is
used in conjunction with eye surgery and a cardioplegic solution
used to induce cardiac muscle paralysis to prevent injury to the
heart during open heart surgery.
"So far, no cases of fungal meningitis have been confirmed in
Georgia," said Brenda Fitzgerald, M.D., commissioner of the
Georgia Department of Public Health (DPH), noting that response
to symptoms must occur quickly. "We now have the ability to keep
clinicians up-to-date with the latest information and we're
using that capability."
Fitzgerald has been communicating with approximately 32,000
physicians and physician assistants in Georgia via email to
explain the widening U.S. recall of medications manufactured by
NECC. Agents from the FDA's Office of Criminal Investigations
visited the New England Compounding Center in Framingham, Mass.,
for the first time, acting on a sealed warrant. Earlier this
month, officials revoked NECC's license, effectively closing the
facility, and are now scrambling to collect and identify
potentially contaminated medications.
The outbreak of fungal meningitis was originally linked to three
potentially contaminated batches of epidural steroid injections
manufactured by NECC. About 14,000 patients nationwide received
potentially contaminated steroid injections in their backs or
other joints since early summer. In Georgia, 184 patients were
injected with those steroids at the Forsyth Street Ambulatory
Surgery Center in Macon, the only Georgia facility known to have
received the shipments.
"Fungal meningitis is not contagious and cannot be transmitted
person to person. That's not our concern," said J. Patrick
O'Neal, M.D., director of the Division of Health Protection.
Fungal meningitis is a slow-to-manifest illness that may take up
to 90 days following an injection to lead to a variety of
symptoms, including fever, new or worsening headache, nausea,
and new neurological deficit (consistent with deep brain
stroke).
"The difficulty in diagnosing fungal meningitis is its
subtlety," Fitzgerald told Georgia clinicians in an email.
About a dozen patients in Georgia reported mild symptoms of
fungal meningitis and were referred to their personal physicians
for evaluation and care. Those patients, along with anyone in
Georgia, who received a drug produced or purchased from NECC
after May 21, 2012, will be closely monitored for weeks.
"We will be in a wait and watch mode for a long time. Diagnostic
and treatment recommendations are going to be new," said O'Neal.
"We're learning as we go on this one."
-Story by Nancy Nydam, DPH Communications