Health
Alert
UPDATED GUIDANCE FROM FDA AND CDC
FUNGAL MENINGITIS OUTBREAK
This health alert provides updated information from the Food and Drug Administration (FDA) and the Centers for Disease Control and
Prevention (CDC) regarding the fungal meningitis outbreak. Specifically,
- FDA provides list of facilities that received products shipped from the New England Compounding Center (NECC). Visit below for
facilities’ list:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm323946.htm.
- CDC Issues Guidance on Management of Asymptomatic Patients Who Received Epidural or Paraspinal Injections with Contaminated Steroid
Products. Please find detailed guidance at: http://emergency.cdc.gov/HAN/han00330.asp.
It is important to note that no facilities in Delaware received the contaminated lots of methylprednisolone acetate (PF) 80mg/ml
(the steroid injection). Facilities in Delaware did receive other products from the New England Compounding Center (NECC) that
are included in the FDA expanded recall.
Background
On October 4, 2012, FDA advised medical professionals that all products produced by NECC should be retained, secured, and withheld from
use. On October 6, NECC announced a voluntary recall of all its products currently in circulation that were compounded at and distributed
from its Framingham, Massachusetts facility. On October 15, 2012, FDA further advised healthcare providers to follow-up with patients who
were administered any NECC injectable product on or after May 21, 2012, including an ophthalmic drug that is injectable
or used in conjunction with eye surgery, or a cardioplegic solution purchased from or produced by NECC.
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FDA provides NECC Customer List
FDA made publicly available two lists of facilities that received products that
were shipped on or after May 21, 2012 from NECC’s Framingham, MA facility. The lists were prepared based on information provided
by NECC, and FDA cannot vouch for the completeness or accuracy of the lists. Products shipped by NECC may be missing from the list and
facility information may be incomplete. Nevertheless, this is the best information that FDA has available to help inform facilities and
healthcare providers.
The following is a list of Delaware facilities, publicly released by FDA, that received any NECC products shipped on or after May 21,
2012. The NECC customer lists can be accessed at: http://www.fda.gov/downloads/Drugs/DrugSafety/FungalMeningitis/UCM325467.pdf
and http://www.fda.gov/downloads/Drugs/DrugSafety/FungalMeningitis/UCM325466.pdf.
Advanced Eye Care PA
Anesthesia Providers
Bayhealth Medical Center
Beebe Medical Center
Richard Bonder, MD, PA
Christiana Health System
Christiana Spine ASC
Glasgow Medical Center
Lewes Surgery Center
Pain Center of Delaware
St. Francis Hospital
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CDC Issues Guidance on Management of Asymptomatic Patients Who Received Epidural or Paraspinal Injections with Contaminated
Steroid Products.
The information in the CDC health alert below is specific to patients who received epidural and
paraspinal injections with the contaminated recalled lots of methylprednisolone acetate and who are asymptomatic (i.e. showing no signs
or symptoms of disease).
CDC analysis suggests that the period of greatest risk for development of fungal meningitis among patients who received epidural or
paraspinal injections with contaminated products (referring to the 3 contaminated recalled lots of methylprednisolone acetate) 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
product 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 (http://www.cdc.gov/hai/outbreaks/clinicians/guidance_asymptomatic_persons.html).
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.
Recommendations
- FDA is reiterating and updating its previous recommendation that follow-up with patients be done when the following three conditions
are met:
-The medication was an injectable product purchased from or produced by NECC, including an ophthalmic drug that is
injectable or used in conjunction with eye surgery, or a cardioplegic solution,
-The medication was shipped by NECC on or after May 21, 2012, and
-The medication was administered to patients on or after May 21, 2012.
-
Advice to NECC Customers
Customers identified on these lists should check their stocks to identify whether they have any products from the New England
Compounding Center (NECC), and they should immediately isolate any identified product from their drug supplies. All NECC products are
subject to voluntary recall. Customers with product on hand should contact NECC at 1-800-994-6322 or via fax at 508-820-1616 to obtain
instructions on how to return products to NECC.
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Advice to Patients
Patients who believe they received an injection or other product that was shipped by NECC on or after May 21, 2012
should remain vigilant for the signs and symptoms of infection, and contact their health care provider if they are concerned. The
meningitis outbreak has occurred in patients who received injections near the spine (back or neck). The signs and symptoms of
meningitis include fever, headache, stiff neck, nausea and vomiting, photophobia (sensitivity to light) and altered mental status.
Symptoms for infections following other types of injections at other body sites may vary, and are not limited to meningitis. Other
possible infections at other parts of the body (e.g., peripheral joints) may include fever; swelling, increasing pain, redness, warmth
at an injection site; visual changes, pain, redness or discharge from the eye; chest pain, or drainage from the surgical site
(infection within the chest).Patients should contact their healthcare provider if they have any of these signs or symptoms.
Patients who received an NECC product prior to May 21, 2012 and who have not experiencing symptoms of infection to date are at less
risk of infection because of the amount of time that has elapsed since that date. FDA is not recommending these patients follow-up with
their healthcare providers unless they are experiencing symptoms of infection.
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Advice to Healthcare Professionals
FDA advises healthcare professionals to follow-up with patients who have been administered an injectable product shipped by
NECC on or after May 21, 2012, including an ophthalmic drug that is injectable or used in conjunction with eye surgery, or a
cardioplegic solution. FDA does not urge patient follow-up at this time for NECC products of lower risk such as topicals (for example,
lotions, creams, eyedrops not used in conjunction with surgery) and suppositories, or for patients who may have received an NECC
product in these categories before May 21, 2012. Patients who received an NECC product prior to May 21, 2012 and who have not
experienced symptoms of infection to date are at less risk of infection because of the amount of time that has elapsed since that date.
FDA is not recommending that healthcare providers follow-up with these patients unless they have reported symptoms of infection.
Health care professionals should retain and secure all remaining products purchased from NECC. All NECC products are subject to
voluntary recall. Clinics or customers with product on hand should contact NECC at 1-800-994-6322 or via fax at 508-820-1616 to obtain
instructions on how to return products to NECC.
Clinicians and patients 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.
Additional Information
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