Multistate Outbreak of Infections Linked to the Use of Oral Liquid Docusate

 In CDC, FDA

Last month, the CDC and FDA investigated a multi-state outbreak of infections caused by Burkholderia cepacia complex. B. cepacia complex is normally not a pathogen in the ambulatory setting, but may colonize and/or infect the respiratory tract of patients with cystic fibrosis or bronchiectasis. Symptoms can vary widely, ranging from mild respiratory symptoms to serious respiratory infections, especially in patients with compromised immune system. The reported infections were primarily in ventilated patients without cystic fibrosis and who were being treated in intensive care units. Preliminary information indicated that contaminated liquid docusate products may be related to these cases. At the time, the CDC recommended that facilities not use any oral liquid docusate products for patients who are critically ill, ventilated or immunosuppressed.

The CDC is continuing to work with the FDA to investigate this issue. Forty-seven B. cepacia complex cases have now been confirmed in five states. The CDC also confirmed that two samples of unused oral liquid docusate product received from one of the affected hospitals have tested positive for B. cepacia complex. The FDA is currently testing multiple liquid docusate products that are linked to the cases.

The CDC has now expanded the warning to all patient populations, including hospice patients, and recommends that clinicians not use any liquid docusate product, as a stool softener or for any other medical purpose. Patients who are currently using oral liquid docusate as laxative should be transitioned to an alternative product such as senna-docusate tablet (may be crushed), liquid senna, sorbital or Milk of Magnesia.

B. cepacia bacteria are often resistant to common antibiotics and decisions on the treatment of infections should be made on a case-by-case basis. Healthcare providers should remain on alert for infections caused by B. cepacia complex and inform infection prevention staff immediately when these infections are identified. Cases should be reported to state or local public health authorities. More information and further updates regarding this outbreak can be found on the CDC website.

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