The Centers for Disease Control and Prevention, (CDC) traced the fungal meningitis outbreak to 3 lots of corticosteroids used for epidural injections, a pain relief treatment for spinal stenosis and herniated discs.
Distribution of the offending medicine has been linked to more than 75 medical clinics in 23 states, and has been allocated to over 14,000 patients between May 21st of this year, to September 24th, 2012 inclusive.
The CDC has indicating that 541 cases have been reported in 19 of the 23 states involved, with 36 deaths.
The New England Compounding Center, (NECC) the Framingham, Massachusetts based compounding pharmacy at the center of this outbreak of fungal meningitis, has been shuttered by the FDA, the offending corticosteroids, termed preservative-free methylprednisolone acetate, have being examined, and several previously unopened lots have been found to contain fungal matter.
In a letter dated December 7, 2012, from the U.S. House of Representatives, COMMITEE ON ENERGY AND COMMERCE, to Scott Karolchyk, President of the International Academy of Compounding Pharmacists, the governing body for all compounding pharmacies in the U.S, Congressional lawmakers indicated that the governing body had ‘coached’ the NECC, on how to deal with Congressional regulators.
The letter reads in part: According to an October 2012 New York Times report, the International Academy of Compounding Pharmacists “tutored pharmacists on how to sidestep [U.S. Food and Drug Administration] requests” for samples related to FDA’s assessment of the quality of compounded drugs. Specifically, the Times stated that your association told its members: “We do not compound or distribute ‘samples’ of any of our prescription medications to anyone. And if a compounded drug was on the premises…a pharmacist should say it was awaiting pickup by a patient.” Allegations that your association may have encouraged compounding pharmacists to attempt to impede the FDA from evaluating the efficacy and safety of their products, if true, raise serious concerns about your actions.
According to the CDC, fungal meningitis is not readily contagious, and cannot be passed from person to person under normal circumstances.
The principally identified fungus is the “Exserohilum Rostratum” fungus, and only 1 patient has been identified with a different variant, the “Aspergillus Fumigatus” fungus. The CDC and FDA have confirmed the presence of the Exserohilum Rostratum fungus in 2 of the 3 lots of unopened vials of the corticosteroid at issue, with testing on the third lot is advancing.
Exserohilum Rostratum fungus, normally termed Setosphaeria Rostrata, is a black mold rarely associated with humans, and normally infects numerous plant species. It is the pathogen responsible for all but one of the infections with regards to the current outbreak.
Because of the rarity of this fungus, and the even rarer assemblage of the fungus into the human species, treatment options are unknown, and this fungus’ advancement into pandemic proportions is not understood at this time, but is being closely watched.
The Aspergillus Fumigatus fungus, a commonly airborne fungus, is widespread in nature and most humans inhale upwards of 2 or 300 or more of these spores daily. Under normal circumstances the body’s immune system counteracts and eliminates these spores, however in persons with immune system deficiencies, like HIV positive individuals and recent transplant patients, or if introduced directly into the spinal column, the fungus can become Patheogenic, and easily overwhelm a patients weakened immune system, causing a host of diseases, and even death.
If you have had an epidural (spinal) injection of corticosteroids since may 21, 2012, and are having symptoms as described below, see your medical provider at once. Fungal Meningitis infections are slow developing infections, and if you have had a recent injection, be sure and pay close attention to the signs and symptoms on the disease.
Symptoms of Fungal Meningitis include:
- Stiff Neck
- Sensitivity to Light
- Slurred Speech
- Weakness or Numbness in any part of your body
- Increased Pain, Swelling or Redness at the point of injection
For more information on Fungal Meningitis and the recent outbreak, follow the links provided for the CDC and the FDA.
The CDC link: www.cdc.gov/hai/outbreaks/meningitis.html
The FDA link: http://www.fda.gov/Drugs/DrugSafety/ucm322734.htm
Article by Jim Donahue