What Should Physicians Be Doing?
October 16, 2012 2:00 PM EDT
- Find out if you have administered a potentially contaminated medication from New England Compounding Center. The three potentially contaminated lots are:
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
- Contact patients who have been exposed. All patients who have received medication from one of these three lots should be immediately contacted directly to determine if they are having any symptoms.
It is important to note that infected patients have presented with mild symptoms, only slightly worse than baseline.
- Refer symptomatic patients for a diagnostic procedure. For patients who received epidural injection with medication from the lots listed above and have any symptoms of meningitis or basilar stroke, a diagnostic lumbar puncture (LP) should be performed, if not contraindicated. Because presenting symptoms of some patients with meningitis have been mild and not classic for meningitis (e.g., new or worsening headache without fever or neck stiffness), physicians should have a low threshold for LP.
When diagnostic lumbar punctures are performed, they should be done through a site other than the site used for epidural injection when possible. The clinical investigation of patients associated with this cluster is ongoing and this recommendation may change as new information becomes available.
Interim instructions regarding diagnostic testing and treatment options are available at http://www.cdc.gov//hai/outbreaks/clinicians/index.html.
- Report concerning cases to public health. Physicians should report suspected cases to their state health department.
Clinicians are also requested to report any suspected adverse events following use of these products to FDA's MedWatch program at 1-800-332-1088 or www.fda.gov/medwatch.
- Use appropriate treatment for fungal meningitis, parameningeal infections, and joint infections.
- Initiate empiric antifungal therapy after collecting cerebrospinal fluid for culture using the appropriate regimen found in the Interim Treatment Guidance for Central Nervous System (CNS) and/or Parameningeal Infections Associated with Injection of Potentially Contaminated Steroid Products in addition to routine empiric treatment protocols to cover for potential bacterial pathogens until the etiology of the patient’s CNS and/or parameningeal infection has been identified.
Fungal Joint Infections
- When empiric antifungal therapy is initiated, use the appropriate regimen found in the Interim Treatment Options for Septic Arthritis Associated With Injection of Potentially Contaminated Steroid Products until the etiology of the patient’s septic arthritis has been identified.