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4/22/2002

FDA Warns Against Contamination of Albuterol Solutions

Kate Traynor

The Food and Drug Administration (FDA) cites poor infection-control procedures as the cause of two recent hospital outbreaks of Burkholderia cepacia infection among patients treated with albuterol sulfate for inhalation.

According to FDA, respiratory therapists who administered albuterol sulfate to hospitalized patients apparently contaminated multiple-dose bottles of the drug with B. cepacia. FDA reported that the bacterium was likely spread by the respiratory therapists' practice of using one multiple-dose bottle of the drug to treat several patients.

At least one patient died during the recent outbreaks, which were reported in an April 19 public health advisory from MedWatch, FDA's safety and adverse-event reporting program.

To prevent B. cepacia infection, FDA recommended that hospitals use proper infection-control procedures and adequately train staff who prepare and administer albuterol sulfate. The agency also suggested that hospitals refrain from using the same multiple-dose bottle of albuterol sulfate to treat more than one patient. FDA also reminded people who administer albuterol sulfate to follow the instruction on the product's label that warns against touching the dropper tip of the bottle to any surface.

FDA noted in the MedWatch advisory that other cases of hospital-acquired B. cepacia have been described in the medical literature, with most outbreaks occurring in intensive care units.

A report in the May 15, 1995, Annals of Internal Medicine described a B. cepacia outbreak that affected 42 patients who received nebulized albuterol sulfate at the Department of Veterans Affairs medical center in Houston. The outbreak was halted after the hospital staff adopted proper infection-control measures and stopped using one multiple-dose bottle of albuterol sulfate for more than one patient.

B. cepacia is found in soil and moist environments and can infect both plants and humans. A report in the April–June 1998 issue of Emerging Infectious Diseases (PDF) noted that the opportunistic organism has become a noteworthy human pathogen, particularly among hospitalized patients and people with an immune deficiency. According to the report, lung infections caused by B. cepacia are particularly troublesome for patients with cystic fibrosis.