HSA Updates
HSA Updates on the Recent Outbreak of Meningitis in the US
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17 October 2012
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This is an update on the recent outbreak of meningitis in the US among patients who have received an epidural steroid injection, namely methylprednisolone acetate.
2 The product, preservative-free methylprednisolone acetate, an injectable steroid produced and distributed by New England Compounding Center (NECC), in Framingham, Massachusetts has recently been implicated in the outbreak of meningitis in the United States. The cause of infection is suspected to be due to fungal contamination of the product. However, this product is not available in Singapore. None of NECC's products are registered in Singapore.
Background information
3 The US Food and Drug Administration (FDA) is working closely with the Communicable Diseases Centre (CDC) to investigate the cause of an outbreak of meningitis among patients who had received epidural methylprednisolone injection. Investigation into the exact source of the outbreak is still ongoing, but the outbreak is associated with preservative-free methylprednisolone acetate. CDC's interim data show that all infected patients received injection with this product. As part of the ongoing investigation, FDA has confirmed the presence of a fungal contaminant in multiple sealed vials of preservative-free methylprednisolone acetate injection from NECC and from samples of the product collected around the country.
4 As of 3 October 2012, NECC has voluntarily shut down its premises. On 6 October 2012, NECC announced a voluntary recall of all products currently in circulation that were compounded at and distributed from its facility in Framingham, Massachusetts.
HEALTH SCIENCES AUTHORITY
SINGAPORE
17 OCTOBER 2012