October 24, 2012 — The U.S. Food and Drug Administration (FDA) has published a list of customers who received medicines from New England Compounding Center (NECC), the compounding pharmacy at the heart of a massive outbreak of fungal meningitis. As of today, more than 300 people have been sickened and 24 have died in 17 states. The FDA has compiled a list of customers who received products that were shipped on or after May 21, 2012. The medicines may have been contaminated.
The FDA posted the list of customers yesterday, but retracted it after discovering an error. The list was re-posted today, cautioning that:
“The lists were prepared based on information provided by NECC, and FDA cannot vouch for the completeness or accuracy of the lists. Products shipped by NECC may be missing from the list and facility information may be incomplete. Nevertheless, this is the best information we have available, at this time, to help inform facilities and healthcare providers of NECC products shipped to their facilities since May 21, 2012.”
The FDA is recommending that healthcare professionals follow-up with patients who were exposed to an injectable medication from NECC (including epidural steroid injections, injectable opthalmic drugs used in eye surgery, cardioplegic drugs used in heart surgery, and others). Medications may have been contaminated if they were shipped from NECC after May 21 and administered to a patient after May 21.
According to the FDA, May 21, 2012 is the earliest-known date when lots of methylprednisolone acetate (an injectable steroid shot) were implicated in the outbreak. The steroid shots were sold without a preservative, which makes sterility essential because funguses will grow aggressively if the product is contaminated.
The FDA has also identified the specific type of fungus associated with most of the illnesses — Exserohilum rostratum, a non-contagious fungus that does not normally cause illness, and is commonly found in rotting plant material. Interestingly, when the first case of fungal meningitis was identified in September, the Aspergillus fumigatus fungus was implicated.
It has been more than one month since the FDA and NECC recalled the methylprednisolone acetate injections. Health experts believe that fungal meningitis has an incubation period of about a month, but they are unsure whether this particular outbreak will have a longer or shorter incubation period.