Confirms presence of fungal contaminant in multiple sealed vials made by NECC, Framingham
The FDA is continuing to investigate a fungal meningitis outbreak, which has killed 15 and as many as 14,000 people received possibly tainted steroid injections produced by the New England Compounding Center in Massachusetts.
The US regulator aims to contain the health risk as quickly as possible, saying that it is dedicating ‘many resources’ to the investigation.
The FDA has confirmed the presence of a fungal contaminant in multiple sealed vials of methylprednisolone acetate (80mg/ml), an injectable steroid injection made by the New England Compounding Center’s (NECC) Framingham site and from samples collected around the US.
The regulator, in partnership with the US Centers for Disease Control and Prevention (CDC), is trying to identify the exact species of fungus isolated from the sealed vials and whether the fungus is the same as one of two fungal organisms found in patients who had received an epidural steroid injection.
The CDC said 15 patients have died from a rare form of fungal meningitis and 169 people have so far been infected in 11 US states, with Tennessee the hardest hit.
As well as confirming the presence of a contaminant in the vials, the FDA is also reviewing the processes, procedures, and documentation at the NECC facility.
As a precaution, the FDA is urging patients who believe they received an injection or other product compounded by NECC to remain vigilant for the signs and symptoms of infection, including meningitis.
Based on the business relationship between NECC and Ameridose, the FDA and the Massachusetts Board of Pharmacy launched a joint inspection at the Ameridose facility in Westborough, Massachusetts on 10 October.
‘As part of our efforts to protect the public health, FDA is investigating whether certain aspects of compounding practices and facility conditions observed at NECC may be present at the Ameridose facility,’ the regulator said.
The FDA will review whether Ameridose has procedures and facilities necessary to produce and provide sterile drug products safely. There is currently no known contamination of products produced by Ameridose.
The NECC voluntarily shut down on 3 October and following an earlier recommendation by the FDA that none of the firm's compounded products be used, announced a voluntary recall on 6 October of all products currently in circulation from its Framingham facility.
The FDA is taking the additional step of recommending that healthcare professionals and consumers do not use any product that was produced by NECC at this time.
All remaining products purchased from NECC should be retained and secured until the FDA provides further instructions regarding these products.