Originally published on Oct. 22, 2012
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."