FDA pathogen warning follows rise in drug product recalls

Published: 9-Jun-2017

The US FDA has advised drug manufacturers to be aware that Burkholderia cepacia complex poses a contamination risk in non-sterile, water-based drug products

The FDA has advised manufacturers of non-sterile, water-based drug products that there have been recent product recalls due to Burkholderia cepacia complex (BCC or B. cepacia) contamination.

BCC and other water-borne opportunistic pathogens are among the contaminants that can be found in pharmaceutical water systems.

BCC can survive or multiply in a variety of non-sterile and water-based products because it is resistant to certain preservatives and antimicrobial agents.

Detecting BCC bacteria is also a challenge and requires validated testing methods that take into consideration the unique characteristics of different BCC strains.

People exposed to this pathogen are at an increased risk for illness or infection, especially patients with compromised immune systems.

Specifically, the FDA has set out six steps for drug manufacturers to help prevent, test and investigate any cases of such contamination.

It says adverse events or quality problems experienced with the use of a non-sterile water-based drug product should be reported to the FDA’s MedWatch Adverse Event Reporting programme.

Visit https://www.fda.gov/Drugs/DrugSafety/ucm559508.htm for the more details.

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