North American Spine Society issues fungal meningitis safety alert

DALLAS – Spine surgeons should contact all patients who may have meningitis, however, patients should use the medications recently recommended by the Centers for Disease Control and Prevention only if needed to avoid adverse events, according to an update on the meningitis outbreak presented at the North American Spine Society Annual Meeting, here.

“Certainly within my lifetime, this recent issue we have had with meningitis and epidural steroids is probably the most significant patient safety problem that we have run into,” David A. Wong, MD, MSc, FRCS(C), co-chair of North American Spine Society (NASS) Patient Safety Committee, said in his presentation on this topic.

David A. Wong

As of Oct. 23, there were 308 cases of fungal meningitis. There have been 23 deaths in 17 states, and an estimated 14,000 patient exposures.

On Sept. 21, the Tennessee Department of Health notified the Centers for Disease Control and Prevention (CDC) of the first case of meningitis, a person infected with Aspergillus fumigatus 19 days after an epidural methylprednisolone acetate injection. However, the next 45 patients tested positive for Exserohilum rostratum, a fungus found in mold, grasses, soil and plants and is the “main pathogen at this stage of the game,” Wong said.

New England Compounding Center, the manufacturer of the 80-mg/mL injections, voluntarily recalled the product on Sept. 26. The manufacturer also had to recall all of its other products, including the spinal anesthetic, ephedrine. Among the three lots voluntarily recalled are:

lot #05212012@68, BUD 11/17/2012

lot #06292012@26, BUD 12/26/2012

lot #08102012@51, BUD 2/6/2013

The cause of death of most patients was vasculitis and stroke with some epidural abscesses. Wong said all states are at risk because the product was shipped to all 50 states. Tennessee, Michigan and Virginia have the highest number of cases.

The FDA has limited oversight over compounding pharmacies, which are mainly policed by state pharmacy boards. In 1997, some laws were passed to oversee them, but “if you did not advertise or solicit business, you were exempt, and small pharmacies were exempt,” Wong said. Lawmakers attempted to draft a law for stricter oversight in 2007, but never voted on it.

Wong recommends contacting all patients who may have been exposed and watching for meningitis symptoms. He said the CDC only recommends treating patients who are “significantly symptomatic” with voriconazole or liposomal amphotericin B because the medications carry significant risks of adverse effects, including ototoxicity, deafness and kidney or liver problems.

Wong questioned whether patients who had only intrathecal injections are showing signs of the illness. There are connections between the arachnoid villi into the epidural veins that empty into the cerebrospinal fluid space, he said. If the arachnoid villi connect and there are many epidural abscesses showing up in patients from the injections, why have not more patients shown signs of meningitis, he asked.

“The kinds of pathophysiology issues I think the CDC is going to have to look at is, okay, were these from translaminar injections vs. transforaminal?” he said. “Was it from folks that have spinal stenosis where there is very little epidural space vs. a herniated disc? I think there is a lot of information yet to come out on this.”

Reference:

Wong D. Meningitis outbreak update. Presented at: North American Spine Society Annual Meeting; Oct. 24-27, 2012; Dallas.

Disclosure: Wong receives royalties from Lippincott, Williams and Wilkins, owns stock in Neurotech/CervIOM, Denver Imaging North and Huron Shores, is a consultant for Anulex, Allosource, DeRoyal and United Healthcare, has speaking or traveling arrangements with Anulex Trips, is on the scientific advisory board of United Healthcare and receives research support from Abbott, Anulex and Cervitech/NuVasive.