Contaminated Steroid Injections: Fungal Meningitis

As many as 13,000 contaminated steroid shots were administered throughout the US resulting in an outbreak of meningitis that has sickened over two hundred and resulted in 19 deaths.

The contaminated batches of the steroid, methylprednisolone acetate, were all made by a single lab that is now under federal investigation.

Fungal Meningitis

Meningitis is an inflammation of the membrane around the spinal cord and brain. This system of membranes is known as the meninges.

While meningitis can be caused by a virus, bacteria, or fungus, fungal meningitis is considered the most difficult to treat. Patients with fungal meningitis are susceptible to strokes. Several of those sickened in the recent outbreak have suffered strokes.

The fungus that is the primary focus for these cases of fungal meningitis is known as Exserohilum. Normally found in plant materials, particularly grasses, this mold is rarely seen in human infections. A second fungus, Aspergillus, has also been identified by the CDC in their multi state meningitis outbreak investigation.

Steroid injections for pain

A combination steroid and numbing agent, the goal behind these injections is to treat pain. The numbing agent provides immediate relief while the steroid takes longer to work. Proponents say patients can get weeks, months, or even a year of pain relief.

Methylprednisolone acetate, the compound being made by New England Compounding Center, was used primarily to treat neck and back pain. This effectiveness of these injections to treat such pain has been questioned by some experts. A Cochrane Collaboration review concluded "that there is no strong evidence for or against the use of any type of injection therapy for individuals with subacute or chronic low-back pain."

According to the CDC, "injections into joints other than the spine (e.g., knee, hip) have not been reported. However, the investigation is ongoing and joint infections may take longer to develop than meningitis." Patients who received injections at other sites should be on the lookout for the signs of infection: fever, swelling, pain, heat, and/or redness.

Recall

On October 6, 2012, The New England Compounding Center (NECC) issued a voluntary recall of all products from their Framingham, MA facility:

New England Compounding Pharmacy, Inc. d/b/a New England Compounding Center (NECC) today announced a recall of all products currently in circulation that were compounded at and distributed from its facility in Framingham, Massachusetts. This action is being taken out of an abundance of caution due to the potential risk of contamination, and in cooperation with an investigation being conducted by the U.S. Food and Drug Administration, the Centers for Disease Control and Prevention and the Massachusetts Board of Registration in Pharmacy. The FDA had previously issued guidance for medical professionals that all products distributed by NECC should be retained and secured. While there is no indication at this time of any contamination in other NECC products, this recall is being taken as a precautionary measure. Products from NECC can be identified by markings that indicate New England Compounding Center by name or by its acronym (NECC), and/or the company logo that can be accessed here. A complete list of all products subject to this recall can be accessed here.

NECC is notifying its customers of this recall by fax. Clinics, hospitals and health care providers that have product which is being recalled should stop using the product immediately, retain and secure the product, and follow instructions contained in the fax notice.

Adverse reactions or quality problems experienced with the use of any product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Online: www.fda.gov/medwatch/report.htm
• Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form.
• Fax: 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Sources

1. Staal JB, de Bie R, de Vet HCW, Hildebrandt J, Nelemans P. "Injection therapy for subacute and chronic low-back pain." Cochrane Database of Systematic Reviews 2008, Issue 3. Art. No.: CD001824. DOI: 10.1002/14651858.CD001824.pub3 <http://summaries.cochrane.org/CD001824/injection-therapy-for-subacute-and-chronic-low-back-pain>
2. Grady, Denise; Pollack, Andrew; Tavernise, Sabrina. "Scant Oversight of Drug Maker in Fatal Meningitis Outbreak," The New York Times. October 6, 2012. <http://www.nytimes.com/2012/10/10/health/as-meningitis-death-toll-rises-lawmakers-call-for-more-oversight.html?_r=0>
3. Ghianni, Tim. "Calls for oversight grow as meningitis death toll mounts," Reuters. October 10, 2012. <http://www.reuters.com/article/2012/10/10/us-usa-health-meningitis-idUSBRE8970TQ20121010>
4. "FDA Statement on Fungal Meningitis Outbreak," FDA. October 6, 2012 <http://www.fda.gov/Drugs/DrugSafety/ucm322734.htm>

 

 

Quick Facts

• 17,676 vials
• 23 states received vials
• 15 states have reported illnesses
• 247 sickened
• 19 dead
• Onset of symptoms is typically 1-4 weeks
• Injections given in spine are of most concern

Information last updated: Oct. 17, 2012.