Health

Alert

UPDATE: CONTAMINATION OF ADDITIONAL MEDICAL PRODUCTS FROM NEW ENGLAND COMPOUNDING

The Delaware Division of Public Health (DPH) is issuing this health alert to provide healthcare providers and facilities with details

regarding additional contaminated medical products identified in the ongoing Food and Drug Administration (FDA) investigation associated

with the fungal meningitis outbreak. In a previous DHAN, DPH reported information from the Centers for Disease Control (CDC) and FDA

regarding contaminated betamethasone and cardioplegia solution. A recently released CDC Health Alert provides additional information on

contaminated triamcinolone. It is unknown whether facilities in Delaware received the lots of contaminated betamethasone, triamcinolone

or cardioplegia solution.

Background

The CDC is reporting that product testing has identified bacterial contamination with several bacterial and fungal organisms in unopened

vials of betamethasone, triamcinolone, and cardioplegia solution that were distributed and later recalled by NECC on October 6, 2012. To

date, although CDC has received reports of illness in patients who have received the medications listed in the table below, including

some patients who had evidence of meningeal inflammation, CDC and public health officials have no reports of laboratory-confirmed

bacterial or fungal meningitis, spinal, or paraspinal infections caused by these products. The available epidemiological and laboratory

data do not, at this time, support evidence of an outbreak of infections linked to usage of non-methylprednisolone NECC products.

The following table provides CDC and FDA laboratory testing results and product lot numbers for the contaminated triamcinolone. See the

CDC health alert (http://emergency.cdc.gov/HAN/han00337.asp) for updated

information on the betamethasone and cardioplegia solution.

Medication	Lot number	Microbial contamination
Triamcinolone* 40mg/mL injectable – 1 mL per vial	06062012@6	Bacillus lentus, Bacillus circulans
Triamcinolone 40 mg/mL injectable – 2 mL per vial	08172012@60	Aspergillus tubingensis, Penicillium sp.
Triamcinolone 40mg/mL injectable – 10 mL per vial	08242012@2	Aspergillus fumigatus

Recommendations

1. Clinicians should consider these product findings when reviewing laboratory results from patients who have been exposed to a NECCproduct.
2. Do not use any product produced by NECC as previously recommended by CDC and FDA.
3. Continue follow-up of patients who received any injectable NECC product, including betamethasone, triamcinolong, and cardioplegiasolution purchased from or distributed by NECC after May 21, 2012.
4. For healthcare providers diagnosing and treating symptomatic patients who have received NECC products, CDC recommendations have notchanged and can be found at http://www.cdc.gov/hai/outbreaks/clinicians/index.html#Guidance.

Additional Information

• CDC health alert: http://emergency.cdc.gov/HAN/han00337.asp
• CDC’s clinical guidance regarding diagnosis and treatment of symptomatic patients: http://www.cdc.gov/hai/outbreaks/clinicians/index.html#testing
• Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these productsonline at www.fda.gov/MedWatch/report.htm
• Delaware Division of Public Health, Bureau of Epidemiology (24/7): 1-888-295-5156

******************

You are receiving this message because you are a registered member of the Delaware Health Alert Network. If you are not a member and

would like to subscribe, please register at https://healthalertde.org