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,

1. FDA provides list of facilities that received products shipped from the New England Compounding Center (NECC). Visit below forfacilities’ list:

   http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm323946.htm.

2. CDC Issues Guidance on Management of Asymptomatic Patients Who Received Epidural or Paraspinal Injections with Contaminated SteroidProducts. 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.

1. 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: https://www.fda.gov/downloads/Drugs/DrugSafety/FungalMeningitis/UCM325467.pdf

   and https://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

2. 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

1. FDA is reiterating and updating its previous recommendation that follow-up with patients be done when the following three conditionsare 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.

2. 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.

3. 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.

4. 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

• Multistate Fungal Meningitis Outbreak Investigation (http://www.cdc.gov/hai/outbreaks/meningitis.html)
• MMWR Early Release: Multistate Outbreak of

  Fungal Infection Associated with Injection of Methylprednisolone Acetate Solution from a Single Compounding Pharmacy — United

  States, 2012. ( http://www.cdc.gov/mmwr/preview/mmwrhtml/mm61e1012a1.htm?s_cid=mm61e1012a1_w

  )

• CDC HAN Advisory: Update: Multistate Outbreak of Meningitis and Stroke Associated with

  Potentially Contaminated Steroid Medication (http://www.bt.cdc.gov/HAN/han00328.asp)

• CDC Website on Fungal Diseases (http://www.cdc.gov/fungal/)
• FDA Statement on Fungal Meningitis Outbreak (http://www.fda.gov/Drugs/DrugSafety/ucm322734.htm)
• Delaware Division of Public Health, Bureau of Epidemiology (24/7): 1-888-295-5156
• Delaware Division of Public Health Webpage on meningitis: https://dhss.delaware.gov/dph/files/meningocfaq.pdf

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