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FDA and CDC Continue to Investigate Multistate Outbreak of Antibiotic-resistant Bacteria

Due to an ongoing investigation of a multistate outbreak linked to contaminated liquid docusate products, the Centers for Disease Control and Prevention (CDC) advised healthcare providers against the use of these products.

*Updated on 7/15/2016 at 1:01 PM EST

Due to an ongoing investigation of a multistate outbreak linked to contaminated liquid docusate products, the Centers for Disease Control and Prevention (CDC) advised healthcare providers against the use of these products.

In June, the CDC partnered with the US Food and Drug Administration (FDA), state and local health departments, and several healthcare facilities, to investigate a multistate outbreak of antibiotic-resistant bacterial infections. Initially, contaminated liquid docusate products from one state were the suspected source of the outbreak of infections caused by Burkholderia cepacia.

On June 29, 2016, the CDC released an investigation update indicating that although there was a suspicion as to what may have caused the outbreak, there was neither epidemiologic nor laboratory evidence “to suggest oral capsules or enemas [were] affected.” The CDC advised healthcare providers and facilities against the use of oral liquid docusate products on those individuals who fit the description of the original outbreak population (ventilated patients who do not suffer from cystic fibrosis), until further investigation was conducted. The CDC extended that warning to also include those who may be immunosuppressed.

As of July 14, 2016, there have been 53 cases of B. cepacia complex. Molecular typing has confirmed these cases to match one of the two outbreak strain types which have been identified in healthcare facilities across the affected five states. The CDC is currently investigating additional reports of possible cases from other states.

Through their investigation, the CDC has identified two samples of unused oral liquid docusate products that have been contaminated with B. cepacia complex. These samples were collected from one hospital where cases were identified during the outbreak. The CDC is currently testing the samples to see if the identified bacterial strains from the oral docusate products match those that caused the outbreak.

Currently, the FDA is testing several liquid docusate products, which have been epidemiologically linked to cases of complex B. cepacia. An additional product has been confirmed by the CDC to have B. cepacia complex growth. However, “because of epidemiologic links, [the] CDC is concerned about potential contamination of multiple liquid docusate products, pending FDA’s ongoing investigation of shared ingredients in the products in question.”

The CDC is advising healthcare providers to cease the use of any form of liquid docusate for any purpose, regardless of the patient’s medical condition. The use of alternative therapies is recommended. Healthcare providers and labs are advised to be on alert for infections caused by B. cepacia complex, especially in patients who do not present with cystic fibrosis (CF). If any cases caused by these bacteria are identified, healthcare providers are advised to immediately inform infection prevention staff, regardless of the patient’s medical condition. State or local public health authorities must be notified of clusters or outbreaks caused by B. cepacia complex.

The CDC warns, “Facilities that identify infections caused by B. cepacia complex among non-CF patients or clusters of these infections among CF patients should sequester and save all docusate products used in the facility.”

This is an ongoing investigation. Contagion will provide more information as it is made available.