Rhodococcus Equi Bloodstream Infections Potentially Associated With Contaminated Product

Oakland County, Michigan sent this bulletin at 08/12/2013 09:21 AM EDT

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Please find below a recent MI HAN alert on the above subject.

 

A High Priority Alert has been distributed via the CDC Health Alert Network regarding Rhodococcus Equi bloodstream infections that have been potentially associated with contaminated product distributed by a Texas compounding pharmacy. At present the investigaton has been focused in Texas and NO information has been made available about the out-state distribuion of any product.

Per FDA:
The U.S. Food and Drug Administration is alerting health care professionals not to use any sterile products supplied by Specialty Compounding, Cedar Park, TX, because bacterial infections have been potentially associated with contaminated calcium gluconate infusions produced by the company.

FDA has received reports of 15 adverse events experienced by patients in two hospitals. The 15 patients received an infusion of calcium gluconate 2 grams in Sodium Chloride 0.9% for Injection, which was supplied by Specialty Compounding. The patients then developed bacterial bloodstream infections caused by Rhodococcus equi. These infections are thought to be related to the infusions. Cultures from an intact sample of calcium gluconate compounded by Specialty Compounding show growth of bacteria that are consistent with Rhodococcus species.

Calcium gluconate by infusion can be used to treat conditions associated with low calcium levels in certain circumstances.

FDA is working closely with the Centers for Disease Control and Prevention (CDC) and the Texas state officials to investigate the cause of these bacterial infections. Health care professionals should report any adverse reactions to FDA's MedWatch program either by:

- completing and submitting the report online at www.fda.gov/medwatch/report.htm1; or
- downloading and completing the form, then submitting it via fax at 1-800-FDA-0178

We ask that you also contact the Oakland County Health Division, Communicable Disease Unit at 248-858-0009.

 

Richard Renas, MPH, Epidemiologist, Oakland County Health Division

T: 248-858-0009 C: 248-343-1377 F: 248-858-0178