By Patricia L Johnson
*as of October 18, 2012
The Tennessee Department of Health was first notified on September 18, 2012 of culture-confirmed, Aspergillums fumigatus meningitis. This diagnosis was made 46 days after the patient had received an epidural steroid injection at a Tennessee surgery center.
Within nine days an additional eight patients were clinically diagnosed through collaboration with the CDC, Tennessee Department of Health and the North Carolina Department of Health and Human services. Seven of these patients were in Tennessee and one was in North Carolina.
All nine infected patients had received one or more epidural steroid injections with preservative-free methylprednisolone acetate solution (MPA), compounded at NECC (New England Compounding Center) located in Framington Massachusetts.
It was determined the injections had come from one of three lots of MPA (lot numbers 05212012@68; 06292012@26; and 08102012@51).
During the subsequent investigation, NECC provided the CDC with invoice information indicating approximately 17,500 vials of MPA (80 mg/ml) from these lots had been packaged in 1ml, 2ml, and 5ml vials and subsequently distributed to 75 different facilities in 23 states for treatment of both peripheral joint and back pain.
NECC voluntarily recalled these three lots on September 26, expanded the voluntary to all lots of MPA and all lots of sterile products used for intrathecal injection by October 3 and followed up with a voluntary recall of all remaining products on October 6, 2012.
Click for a listing of all NECC products voluntarily recalled.
Follow-up investigations by CDC as well as state and local health departments indicated there were almost 14,000 patients potentially exposed to medications from at least one of the lot numbers and by October 10, 2012 the various departments advised CDC that approximately 90% of all patients had been contacted at least once, by telephone, voicemail, home visit or registered mail.
Four separate categories of cases have been identified as follows:
- Fungal meningitis or nonbacterial and nonviral meningitis of subacute onset following epidural injection on or after May 21.
- Basilar stroke following epidural injection on or after May 21.
- Spinal osteomyelitis or epidural abscess at the site of injections following epidural or sacroiliac injection on or after May 21.
- Septic arthritis or osteomyelitis of a peripheral joint (e.g., knee) diagnosed following injection of that joint on or after May 21
Clinical meningitis was defined as having one or more symptoms (e.g., headache, fever, stiff neck, or photophobia) and CSF pleocytosis.
Clinically diagnosed septic arthritis was defined as new or worsening pain with presence of effusion or new or worsening effusion.
Many times during this election cycle we have been subjected to the Republican term “Job-Killing Regulations“.
I don’t know about the rest of you, but I’d rather have a few jobs “killed” over government regulations than thousands of Americans dead because the regulations weren’t there to protect the public.
It will be months and perhaps years before we know all the answers to why these particular batches of MPA caused so many deaths and illnesses. In the meanwhile we can be extremely grateful to the CDC, other government agencies as well as Epi-X (the CDC electronic health notification system) for working so quickly to obtain the necessary information on the 14,000 potential cases and notify those patients of the possibility of exposure.
This particular story hits close to home as I’ve had numerous epidural injections over the past several years without side effects. The reason a person has a sacroiliac or epidural steroid injection is because they are in considerable pain and the injection generally takes away a certain amount of pain for a specific period of time, but they don’t always work. I can’t imagine what it would be like to have the injection and then get notified that due to the injection you may be subjected to a life-threatening illness.
© 2012 Patricia L Johnson