CDC Responds to Multistate Outbreak of Fungal Meningitis and Other Infections
Information on this site is focused on the outbreak of fungal meningitis and other infections linked to the use of injectable steroids from three recalled lots of preservative-free methylprednisolone acetate (MPA) distributed by the New England Compounding Center (NECC).
The Centers for Disease Control and Prevention (CDC), in collaboration with state and local health departments and the Food and Drug Administration (FDA), is investigating a multistate outbreak of fungal meningitis and other infections among patients who received contaminated preservative-free MPA steroid injections from NECC. Several patients suffered strokes that are believed to have resulted from their infections. The investigation also includes other infections from injections in a peripheral joint, such as a knee, shoulder, or ankle. Patients who received injections in peripheral joints only are not believed to be at risk for meningitis, but they could be at risk for joint and other infections.
CDC has recently become aware of reports of spinal epidural abscess and arachnoiditis among a number of patients undergoing treatment for fungal meningitis associated with the outbreak. Both conditions are rare but serious disorders in the general population that require prompt medical attention. Most of these early reports have been about patients in Michigan and Tennessee, but other states have reported patients with these conditions as well. Additional information is found in the Clinician FAQ’s. CDC is working with clinicians and public health officials to obtain more information and refine its clinical guidance as needed.
CDC and public health officials are referring any patients who have symptoms that suggest possible infections to their physicians, who can evaluate them further.
About the Outbreak
FDA Updates
- As of November 2, 2012, the predominant fungus identified in patients continues to be Exserohilum rostratum, with 75 CDC laboratory-confirmed cases. One patient, the index case, had a laboratory-confirmed Aspergillus fumigatus infection. These fungi are common in the environment; fungal infections are not transmitted from person to person.
- CDC and FDA have confirmed the presence of a fungus known as Exserohilum rostratum [JPG - 183 KB] in unopened medication vials of preservative-free MPA from two of the three implicated lots (Lot #06292012@26, BUD12/26/2012 and Lot #08102012@51, BUD 2/6/2013). The laboratory confirmation further links steroid injections from these lots from NECC to the outbreak. Testing on the third implicated lot continues.
- CDC and state health departments estimate that approximately 14,000 patients may have received injections with medication from the three implicated lots of methylprednisolone, and nearly 97% have now been contacted for further follow-up.
- Patients and clinicians need to remain vigilant for onset of symptoms because fungal infections can be slow to develop. In this outbreak, symptoms typically have appeared 1 to 4 weeks following injection, but it’s important to know that longer and shorter periods between injection and onset of symptoms have been reported. Therefore, patients and physicians need to closely watch for symptoms for at least several months following the injection. See updated Patient Guidance for more information, and contact your physician if you are concerned you may have become ill from your injection.
- Information about the investigation and guidance for clinicians, including interim treatment guidelines, is available at www.cdc.gov/hai/outbreaks/meningitis.html. CDC recommendations are subject to change as more information becomes available.
Related Drug RecallsRecalls of medications beyond the three lots of preservative-free MPA are ongoing.
- On October 6, 2012 NECC voluntarily recalled all products compounded at and distributed from its facility in Framingham, Massachusetts. The product list [PDF - 71 pages], posted on FDA’s website, was the focus of an October 15 MedWatch Alert. FDA advised clinicians out of an abundance of caution to follow up with patients who were administered NECC injectable products, including an ophthalmic drug that is injectable or used in conjunction with eye surgery and a cardioplegic solution. Investigation and laboratory testing of products is ongoing by CDC and FDA.
- On October 31, 2012 The U.S. Food and Drug Administration announced that Ameridose, LLC, based in Westborough, Mass., voluntarily recalled all of its unexpired products in circulation. Products from Ameridose can be identified by markings that indicate Ameridose by name or by its company logo. A complete list of all products subject to this recall can be accessed at www.ameridose.com. Together with the State of Massachusetts, the FDA commenced the current inspection of the Ameridose facility as part of the agency’s ongoing fungal meningitis outbreak investigation. Ameridose is a company sharing common management by the same parties as New England Compounding Center (NECC) of Framingham, Mass., the firm associated with compounded drugs linked to the ongoing outbreak.
- November 1, 2012 Health Alert Network (HAN): Contamination Identified in Additional Medical Products from New England Compounding Center
- November 1, 2012 Health Alert Network (HAN): Voluntary Recall of All Ameridose Medical Products
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发表于 2012-11-13 16:41
