Contaminated steroids blamed for deadly meningitis outbreak
pharmafile | October 25, 2012 | News story | Manufacturing and Production |Â Â FDA, GMP, NECCÂ
As many as 14,000 patients may have been exposed to contaminated steriods that have led to 23 deaths due to meningitis in the US.
The outbreak has been traced to a single compounding pharmacy business in Massachusetts. Pharmacy compounding businesses are widespread across the US, and make up drugs on a small scale for specific patient requirements.
The firm in question is the New England Compounding Center (NECC) in Framingham, Massachusetts – and it is now emerging that concerns about its GMP practices were raised years ago.
The company’s production of the steroid methylprednisolone used to treat severe pain is at the centre of the outbreak, and the number of confirmed cases rose rapidly in October, with 23 being killed by the serious infection and a further 285 severely ill as a result of the injection.
Unlike pharmaceutical manufacturers, compounding pharmacies are not regulated by the FDA, and are instead overseen by state pharmacy boards.
The FDA is now calling for a tighter regulatory framework, saying its powers should be extended to cover compounding pharmacies. Its oversight of the sector has been diminished in recent years thanks in part to legal challenges to its powers.
Federal and state authorities are investigating if the NECC violated regulations by supplying large orders of medicines without matching its drugs to specific prescriptions for patients or treatment regimens. It is also facing a raft of lawsuits connected to the meningitis outbreak.
Congressional investigators claim that federal and state health regulators knew of potential problems with NECC steroid treatments as long ago as 2002, when officials began inspecting the NECC’s facility after the report of an adverse event linked to the drug.
All NECC products have been recalled, and another production unit in the same business has also had production shut down.
If diagnosed in time, rapid treatment with a powerful antifungal drug can prevent the infection from spreading to the brain, where it can cause strokes and other damage.
Andrew McConaghie
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