FDA, CDC confirm link between PharmaTech product and 60 bacterial infections

The U.S Food and Drug Administration and the CDC have confirmed the link between a contaminated docusate sodium solution made by PharmaTech and a multistate outbreak of Burkholderia cepacia infections. The investigation into the outbreak and the suspected link between contaminated liquid docusate products has been underway since June, according to CDC updates.

In July, the agencies confirmed PharmTech's docusate sodium solution products were contaminated with the bacteria. Subsequently, the Davie, Fla.-based manufacturer of the laxative product voluntarily recalled the solution. The two agencies continued testing oral liquid docusate sodium products developed by other manufacturers to ensure safety and isolate the primary source of the outbreak.

According to a Wednesday update from the FDA, laboratory evidence now suggests PharmaTech's manufacturing facility is the source of the outbreak. Investigators detected B. cepacia in more than 10 lots of the oral solution and identified the bacteria in the water system of the facility where the product is manufactured.

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"Healthcare professionals may resume normal use of oral liquid docusate sodium not manufactured by PharmaTech," said the FDA in Wednesday's update. "FDA will continue to monitor adverse event reports for B. cepacia related to oral liquid docusate sodium. FDA also encourages healthcare professionals and patients to report adverse events or quality problems experienced with the use of oral liquid docusate sodium products to FDA's MedWatch Adverse Event Reporting program."

B. cepacia can be found in soil and water. Though it generally poses little risk to healthy people, individuals with weakened immune systems may be susceptible to severe respiratory infections caused by the bacteria.

According to the CDC, the B. cepacia outbreak linked to PharmaTech infected 60 individuals across eight states, but PharmaTech isn't the only manufacturer dealing with the bacteria: On Oct. 4, Nurse Assist initiated a voluntary recall of its pre-filled saline flushes which have been linked to clusters of B. cepacia bloodstream infections across four states.

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