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 NECC product.
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 cardioplegia solution 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 not changed 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 products online at www.fda.gov/MedWatch/report.htm
• Delaware Division of Public Health, Bureau of Epidemiology (24/7): 1-888-295-5156

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