Report: Meningitis Pharmacy Knew of Mold, Bacteria Issues
Federal health officials say the New England Compounding Center (NECC) – the pharmacy at the center of a fungal meningitis outbreak responsible for 25 deaths – knew bacteria and mold were growing in “clean rooms” where sterile drugs were manufactured but apparently failed to act on the knowledge.
A report issued by the Food and Drug Administration (FDA) says that the specialty pharmacy’s internal surveillance program found contamination with bacteria or mold in over 80 locations at its plant during the last nine months, and at levels above NECC’s own action limits, writes the Washington Post. The company appears to have done nothing to correct the situation, according to the FDA report, which is based on its inspections at the Massachusetts company following a recall of tainted steroid shots linked to the outbreak.
NECC said it would comment after reviewing the FDA’s report, according to the Post.
The Centers for Disease Control and Prevention reports there are now 354 cases of fungal meningitis, including 25 deaths, in 19 states. Seven cases of joint infection have also been reported.
Some 17,000 vials of preservative-free methylprednisolone acetate, a steroid, were shipped in three separate lots from NECC to pain clinics in 23 states to be given as a spinal injection to relieve back pain. One of the three lots was tainted by Exserohilum rostratum, a black mold found in many fungal meningitis patients.
Meningitis is an inflammation of the membranes covering the brain and spinal cord. The symptoms include headache, nausea, dizziness, and fever. However, unlike other types, fungal meningitis is not contagious.
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