FDA: HCPs May Resume Stool Softener Use After Outbreak Source ID’d

Laboratory evidence from the FDA and CDC confirm the source of the Burkholderia cepacia outbreak.

The Food and Drug Administration’s (FDA) investigation into a recent outbreak of Burkholderia cepacia has found evidence to support the source as being PharmaTech, Florida, where more than 10 lots of oral liquid docusate sodium were found to contain the bacteria.

Burkholderia cepacia was also found in the water system used to manufacture the product by PharmaTech and subsequently distributed and labeled by six firms: Rugby, Major, Bayshore, Metron, Centurion, and Virtus.  

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Evidence from the Center for Disease Control and Prevention (CDC) supports PharmaTech as the source of the outbreak. In light of the findings, the FDA states that healthcare professionals may resume normal use of oral liquid docusate sodium not manufactured by PharmaTech.

Lab test results found no evidence to suggest that the active pharmaceutical ingredient used to manufacture oral liquid docusate is a source of the B. cepacia outbreak.  Other manufacturers were also inspected and samples checked, and the bacteria associated with this outbreak was not found in these other products.

The FDA will continue to monitor for reports of B. cepacia related to oral liquid docusate sodium, in the meantime they encourage healthcare professionals to report adverse events to the FDA’s MedWatch Adverse Event Reporting.

For more information visit FDA.gov.