US meningitis outbreak continues, new products implicated
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US meningitis outbreak continues, new products implicated – Steve McMillan – As of 15 October 2012, the US nationwide fungal meningitis outbreak had grown to 214 cases, including 15 deaths. While initial cases had been linked to three lots of methylprednisolone acetate (MPA) produced at the New England Compounding Center (NECC), the US FDA released a statement on 15 October saying that it was investigating three potential cases possibly associated with other NECC-produced injectable medications. This outbreak has renewed scrutiny on the contemporary practice of pharmacy compounding, and authors of an opinion piece published in Drugs remind prescribers that compounded drugs are produced outside of national regulatory frameworks and lack studies to support their quality, safety and efficacy. On 6 October 2012, the New England Compounding Center (NECC) announced a US nationwide recall of all its products, in response to a number of reports of Aspergillus meningitis among patients who had received epidural injections of methylprednisolone acetate (MPA), compounded at its facility in Framingham, Massachusetts.* Early cases were pinned down to three lots of MPA.1 Invoice information from NECC indicated that approximately 17 500 vials of MPA, from these three lots, had been distributed to 75 facilities across 23 states. The CDC reported that, as of 10 October, state and local health departments had identified almost 14 000 individuals potentially exposed to medications from at least one of these lots. At this time, the US FDA had identified 137 cases and 12 deaths in association with the outbreak in 10 states. Cases included patients with fungal meningitis or nonbacterial/nonviral meningitis of subacute onset; basilar stroke; spinal osteomyelitis or epidural abscess; and septic arthritis or osteomyelitis of a peripheral joint. None of the cases identified as of 10 October were associated with other lots of MPA; and no cases were associated with use of any other NECC product. However, by 15 October, the CDC had noted a total case count of 214, across 15 states, with a total of 15 deaths,2 and the FDA released a statement saying it was investigating a patient with possible meningitis potentially associated with epidural injection of triamcinolone acetonide, produced by NECC.3 The FDA also reported ongoing investigations of two transplant patients with Aspergillus infection who had been administered NECC cardioplegic solution during surgery; though, the agency notes that, at this stage, there may be other explanations for these patients’ infections. While no cases of infection have been reported in connection with any NECC-produced ophthalmic drug that is injectable or used in conjunction with eye surgery, the FDA believes that this class of products could also potentially be associated with similar risks. The agency advises healthcare professionals to follow-up with all patients for whom an injectable product, purchased from or produced by NECC since 21 May 2012, has been administered. This includes opthalmic drugs that
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