Yesterday Digital Journal
reported on the serious case of fungal meningitis from a supposedly sterile medicine (a steroid), which had been distributed across several U.S. states.
The steroid is called methylprednisolone acetate
. It was manufactured by the New England Compounding Center
(NECC) in Framingham, Massachusetts under the brand name Depo-Medrol (as an injectable syringe). The medicine is used to treat pain and swelling that occurs with arthritis and other joint disorders. The shots were then administered by 76 health clinics in 23 US states, often to patients experiencing back pain.
To date twelve people
have died from being injected with the steroid. The most recent two deaths were reported on Saturday in Michigan, according to the Daily Times
The latest report, featured on RT.com
indicates that 137 people have now been reported ill. The number of cases has has more than doubled since Friday. The US Centers for Disease Control has warned
that the number will likely rise. Fungal meningitis is very rare and, unlike viral and bacterial meningitis, is not contagious.
The U.S. Food and Drug Administration, in conjunction with the manufacturer of the steroid, issued a recall notice (see the FDA MedWatch site
). The company who manufactured the drug shut down production and U.S. FDA has launched an investigation
, which is currently on-going. The investigation is proceeding with assistance from the Massachusetts Board of Pharmacy.
It is not certain how many
people have been exposed to the contamination because fungal meningitis can have a lengthy incubation period.
International contamination control expert Barry Friedman
considers that the issue throws up wider questions about the control and regulation of compounding pharmacies. Dr Friedman has said
with regard to drug compounding:
"Unfortunately, this is not the first case in recent months of Pharmaceutical Compounding facilities producing contaminated parenteral product. Franck’s Compounding Lab, Ocala, Florida recently was issued a Warning Letter (7/9/12) for Fusarium contaminated BBG as was InfuPharma, LLC, Hollywood, Florida (7/30/12) for Streptococcus. Both of these companies were found by the FDA to have been repacking sterile injectable vials into sterile injectable syringes which were then being shipped to various end users. The products were found to cause a variety of illnesses because of the contamination. Please visit the Warning Letters for additional information."
Hopefully this unfortunate issue will lead to a wider review of compounding pharmacies.