Health Advisory
MULTISTATE BURKHOLDERIA CEPACIA INVESTIGATION

July 11, 2016

Summary

The Centers for Disease Control and Prevention (CDC) continues to recommend that clinicians not use any liquid docusate product as a stool softener or for any other medical purpose. This recommendation is now expanded to all patient populations. If an oral liquid docusate stool softener is medically necessary, alternative medicines should be used.

Background

The CDC continues to work with the Federal Drug Administration (FDA), health departments, and multiple health care facilities to investigate a multistate outbreak of infections caused by Burkholderia cepacia complex (B. cepacia complex”). In at least one state, there is the concern that oral liquid docusate product might have been a source of the infection.

Recommendations/Reporting

At this time, the CDC continues to recommend that clinicians not use any liquid docusate product as a stool softener or for any other medical purpose. This recommendation is now expanded to all patient populations. If an oral liquid docusate stool softener is medically necessary, alternative medicines should be used.

The CDC urges health care providers and laboratories to remain on alert for infections caused by B. cepacia complex occurring among non-cystic fibrosis (CF) patients and to inform infection prevention staff immediately when these infections are identified. In addition, although infections caused by B. cepacia complex are known to occur among patients with CF, any clusters of such infections should be reported. Cases and clusters should be reported to state or local public health authorities.

To report suspected cases in Delaware call the Office of Infectious Disease Epidemiology at 302-744-4990 or 888-295-5156 (24/7).

Facilities that identify infections caused by B. cepacia complex among non-CF patients or clusters of theseinfections among CF patients should sequester and save all docusate products used in the facility.

Investigation Update

To date, 47 B. cepacia complex cases have been confirmed by molecular typing to match one of two outbreak strain types identified from health care facilities in five states. Reports of possible cases from additional states are currently being investigated. The CDC has confirmed that two samples of unused oral liquid docusate product received from one of the affected hospitals has tested positive for B. cepacia complex. Further testing is being conducted to determine if bacteria from these samples match the outbreak strains. The FDA is currently testing multiple liquid docusate products that are epidemiologically linked to reported B. cepacia complex cases. To date, the CDC has confirmed one product as having B. cepacia complex growth; however, because of epidemiologic links, the CDC is concerned about potential contamination of multiple liquid docusate products, pending the FDA’s ongoing investigation of shared ingredients in the products in question.

The CDC will provide an update to this announcement by July 14, 2016. Direct any questions to haioutbreak@cdc.gov.

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