Background: No guidelines exist for the type of mouthwash that should be used in patients at increased risk for pneumonia. In 2005, we investigated a multistate outbreak of Burkholderia cenocepacia associated with an intrinsically contaminated alcohol-free mouthwash (AFM).
Methods: We conducted a case-series investigation. We used repetitive extragenic palindromic- polymerase chain reaction typing and pulsed-field gel electrophoresis (PFGE) to characterize available Burkholderia cepacia complex (Bcc) isolates from patients and implicated AFM. Seeding studies were conducted to determine the antimicrobial activity of the AFM.
Results: Of the 116 patients with Bcc infection or colonization identified from 22 hospitals with culture dates from April 7 through August 31, 2005, 105 had infections or colonizations that were due to B cenocepacia. The median age of these 105 patients was 64 years (range, 6 to 94 years), 52% were women, 55% had evidence of infection, and 2 patients died. Of 139 patient culture specimens, 83 (60%) were from the respiratory tract. Among 103 Bcc patient isolates characterized, 81 (76%) had an indistinguishable PFGE pattern compared to the outbreak strain cultured from implicated lots of unopened AFM; the species was B cenocepacia. Seeding studies showed that the contaminated AFM might have had inadequate amounts of the antimicrobial agent cetylpyridinium chloride.
Conclusions: This intrinsically contaminated AFM led to a geographically dispersed outbreak of B cenocepacia. AFM without therapeutic label claims is regulated by the US Food and Drug Administration as a cosmetic rather than a drug and is therefore subject to limited quality control requirements. Clinicians should be aware that AFM is not sterile. Its use in intubated and other patients with increased risk of aspiration should be avoided.