miércoles, 24 de octubre de 2012

Health Alert Network | HAN Archive - 00329

This is an official

CDC HEALTH ADVISORY

Distributed via Health Alert Network
October 23, 2012, 22:00 ET (10:00 PM ET)
CDCHAN-00330-2012-10-23-UPD-N

Issuance of Guidance on Management of Asymptomatic Patients Who Received Epidural or Paraspinal Injections with Contaminated Steroid Products

As part of its ongoing investigation of the multistate outbreak of fungal infections, the Centers for Disease Control and Prevention (CDC) continues to assess and revise interim guidance to clinicians involved in the management of patients who received injections with contaminated steroid products distributed by the New England Compounding Center (NECC).¹ Since early in the outbreak, CDC has recommended against antifungal prophylactic or presumptive treatment of exposed asymptomatic patients in the absence of diagnostic testing with results indicating meningitis. This recommendation remains unchanged.
Nevertheless, CDC recognizes the need to assist clinicians in managing asymptomatic patients who received epidural or paraspinal injections with contaminated steroid products.¹ CDC is releasing updated interim guidance to clinicians based on new data that has become available during this investigation.
CDC analysis suggests that the period of greatest risk for development of fungal meningitis among patients who received epidural or paraspinal injections with contaminated products¹ is during the first 6 weeks (42 days) after injection; therefore, additional monitoring of these patients should be considered. Accordingly, CDC provides guidance for asymptomatic patients who received epidural or paraspinal injections with contaminated steroid product¹ within the last 6 weeks (42 days), and those who received such products longer than 6 weeks (42 days) ago. For specific details about the updated guidance, see Guidance on Management of Asymptomatic Patients Who Received Epidural or Paraspinal Injections with Contaminated Steroid Products.
As stated above, CDC does not recommend initiation of antifungal treatment in the absence of diagnostic test results indicating fungal meningitis in exposed patients who are asymptomatic. Currently available data do not suggest an added benefit to this approach in comparison to the strategies outlined in the updated guidance, and patients may experience serious adverse drug events associated with treatment.
The guidance and estimates are based on data currently available to CDC. Additional data that are gathered from existing and newly reported cases of infection, when combined with previous data, may alter the guidance and estimates. Clinicians and others with patients under their care who use the guidance and estimates should check CDC’s website for the most up-to-date information, since it is subject to change periodically.
For the most recent information about this and other clinical guidance as well as case definitions being used in the current investigation, visit CDC’s Clinician Guidance web page.

1. NECC lots of methylprednisolone acetate (PF) 80mg/ml:

Methylprednisolone Acetate (PF) 80 mg/ml Injection, Lot #05212012@68, BUD 11/17/2012
Methylprednisolone Acetate (PF) 80 mg/ml Injection, Lot #06292012@26, BUD 12/26/2012
Methylprednisolone Acetate (PF) 80 mg/ml Injection, Lot #08102012@51, BUD 2/6/2013

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

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