Document Detail


Fungal infections associated with contaminated methylprednisolone in Tennessee.
MedLine Citation:
PMID:  23131029     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: We investigated an outbreak of fungal infections of the central nervous system that occurred among patients who received epidural or paraspinal glucocorticoid injections of preservative-free methylprednisolone acetate prepared by a single compounding pharmacy.
METHODS: Case patients were defined as patients with fungal meningitis, posterior circulation stroke, spinal osteomyelitis, or epidural abscess that developed after epidural or paraspinal glucocorticoid injections. Clinical and procedure data were abstracted. A cohort analysis was performed.
RESULTS: The median age of the 66 case patients was 69 years (range, 23 to 91). The median time from the last epidural glucocorticoid injection to symptom onset was 18 days (range, 0 to 56). Patients presented with meningitis alone (73%), the cauda equina syndrome or focal infection (15%), or posterior circulation stroke with or without meningitis (12%). Symptoms and signs included headache (in 73% of the patients), new or worsening back pain (in 50%), neurologic symptoms (in 48%), nausea (in 39%), and stiff neck (in 29%). The median cerebrospinal fluid white-cell count on the first lumbar puncture among patients who presented with meningitis, with or without stroke or focal infection, was 648 per cubic millimeter (range, 6 to 10,140), with 78% granulocytes (range, 0 to 97); the protein level was 114 mg per deciliter (range, 29 to 440); and the glucose concentration was 44 mg per deciliter (range, 12 to 121) (2.5 mmol per liter [range, 0.7 to 6.7]). A total of 22 patients had laboratory confirmation of Exserohilum rostratum infection (21 patients) or Aspergillus fumigatus infection (1 patient). The risk of infection increased with exposure to lot 06292012@26, older vials, higher doses, multiple procedures, and translaminar approach to epidural glucocorticoid injection. Voriconazole was used to treat 61 patients (92%); 35 patients (53%) were also treated with liposomal amphotericin B. Eight patients (12%) died, seven of whom had stroke.
CONCLUSIONS: We describe an outbreak of fungal meningitis after epidural or paraspinal glucocorticoid injection with methylprednisolone from a single compounding pharmacy. Rapid recognition of illness and prompt initiation of therapy are important to prevent complications. (Funded by the Tennessee Department of Health and the Centers for Disease Control and Prevention.).
Authors:
Marion A Kainer; David R Reagan; Duc B Nguyen; Andrew D Wiese; Matthew E Wise; Jennifer Ward; Benjamin J Park; Meredith L Kanago; Jane Baumblatt; Melissa K Schaefer; Brynn E Berger; Ellyn P Marder; Jea-Young Min; John R Dunn; Rachel M Smith; John Dreyzehner; Timothy F Jones;
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Publication Detail:
Type:  Journal Article; Research Support, Non-U.S. Gov't; Research Support, U.S. Gov't, P.H.S.     Date:  2012-11-06
Journal Detail:
Title:  The New England journal of medicine     Volume:  367     ISSN:  1533-4406     ISO Abbreviation:  N. Engl. J. Med.     Publication Date:  2012 Dec 
Date Detail:
Created Date:  2012-12-11     Completed Date:  2012-12-14     Revised Date:  2013-10-31    
Medline Journal Info:
Nlm Unique ID:  0255562     Medline TA:  N Engl J Med     Country:  United States    
Other Details:
Languages:  eng     Pagination:  2194-203     Citation Subset:  AIM; IM    
Affiliation:
Division of Communicable and Environmental Diseases and Emergency Preparedness, Tennessee Department of Health, 1st Fl., Cordell Hull Bldg., 425 5th Ave. N., Nashville, TN 37243, USA. marion.kainer@tn.gov
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MeSH Terms
Descriptor/Qualifier:
Adult
Aged
Aged, 80 and over
Ascomycota / isolation & purification*
Aspergillosis / diagnosis,  epidemiology
Aspergillus fumigatus / isolation & purification*
Disease Outbreaks*
Drug Compounding
Drug Contamination*
Female
Glucocorticoids* / administration & dosage
Humans
Injections, Epidural / adverse effects
Injections, Spinal / adverse effects
Male
Meningitis, Fungal / diagnosis,  epidemiology*
Methylprednisolone* / administration & dosage
Middle Aged
Pharmacies
Risk Factors
Tennessee / epidemiology
Grant Support
ID/Acronym/Agency:
1U5OCK000198-01//PHS HHS; 1U5OCK000211-01//PHS HHS; 3U5OCI000929-02S5//PHS HHS; 5U38HM000414-5/HM/NCHM CDC HHS
Chemical
Reg. No./Substance:
0/Glucocorticoids; 83-43-2/Methylprednisolone
Investigator
Investigator/Affiliation:
Angela A Cleveland / ; Kaitlin Benedict / ; Christopher Braden / ; Mary Brandt / ; L Rand Carpenter / ; Alice Guh / ; Julie Harris / ; John Jernigan / ; Robert H Latham / ; Anastasia P Litvintseva / ; Shawn Lockhart / ; Rendi L Murphree / ; Dana Pepe / ; Anne E Purfield / ; Brenda L Rue / ; J Todd Weber / ; Caleb B Wiedeman /

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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