The US Food and Drug Administration (FDA) previously issued guidance for medical professionals that all products distributed by the New England Compounding Center (NECC) should be retained, secured, and withheld from use.
Based on new information from the ongoing investigation, the FDA advises follow-up with patients who received an injectable product, including an ophthalmic drug that is injectable or used in conjunction with eye surgery or a cardioplegic solution bought from or produced by NECC after May 21, 2012.
The FDA does not urge follow-up for lower-risk NECC products, such as topicals (eg, lotions, creams, eyedrops not used in conjunction with surgery) and suppositories.
Bruce Frankel, M.D., a neurosurgeon and Director of the Spine Center at the Medical University of South Carolina, provides an update in this video interview on the nationwide fungal meningitis outbreak in patients who have received a contaminated steroid injection as part of a spinal block. This strain of fungal meningitis is not contagious so only those who received the contaminated steroids via an injection to the spine are at risk. Meningitis is an inflammation of theprotective membranes covering the brain and spinal cord.
As of Wednesay, October 11, 2012, twelve people had died as a result of the outbreak, and 130 cases were confirmed. As many as 17,000 vials of steroid contaminated with fungal meningitis, which have since been recalled, were shipped from the New England Compounding Center in Framingham, MA, to 23 states, most along the Eastern seaboard. As many as 13,000 patients may have received spinal injections with the contaminated steroids. Cases have been reported in eleven states, with Tennessee and Michigan being particularly hard hit.
Dr. Frankel emphasizes that MUSC never uses such compounding pharmacies but instead buys directly from the manufacturer to minimize the chances for contamination. According to Dr. Frankel, “the more hands that touch the drug, the greater the chance for contamination.”
No cases have been reported in South Carolina, though a clinic in Mount Pleasant, SC, received and administered some of the contaminated steroids.
Symptoms, which includefever, headache, stiff neck, nausea and vomiting, sensitivity to light, and altered mental status, typically appear within two weeks to a month; however, in one recent case, symptoms appeared 42 days after the injection. It could be early November before the full scope of the problem is known.
According to Dr. Frankel, patients showing such symptoms should immediately seek medical treatmentby contacting their physician or going to the emergency room. A delay in receiving treatment could result in more serious illness or even death. MUSC’s adult and pediatric emergency rooms are open 24 hours a day, 7 days a week, and can evaluate patients who believe they may have been exposed to fungal meningitis via a contaminated steroid injection to the spine.
Intravenous antifungal agents are typically used to treat meningitis; however, intrathecal administration (administration into the cerebrospinal fluid by injection into the subarachnoid space of the spinal cord) may be required for cases that do not respond to standard therapy. Those with compromised immune systems are at particularly high risk and could take longer to respond to treatment.
Dr. Frankel advises patients to be guardians of their own health by asking questions about the medications they are receiving and the procedures they are undergoing. Those receiving a spinal block might ask the source of the steroid and whether a single- or multi-use vial is used (the latter increases the chance of infections though this practice is not implicated in the current outbreak) and what the complications of such a procedure might be.
For more information about MUSC’s Spine Center and its multidisciplinary team of specialists, visit our Web page on MUSChealth.com.