Don’t use liquid docusate sodium stool softener

The CDC and the FDA have been alerting healthcare professionals about a multi-state infection outbreak related to the use of a commonly used over-the-counter liquid stool softener known as docusate sodium.

by Michael R. Cohen, RPh

Published July 18, 2016, 10:32 a.m. ET

The Centers for Disease Control and Prevention (CDC) and the US Food and Drug Administration (FDA) have been alerting healthcare professionals about a multi-state infection outbreak related to the use of a commonly used over-the-counter liquid stool softener known as docusate sodium (Colace and also an ingredient in multiple generic products). Through July 14, the Centers for Disease Control and Prevention (CDC) has confirmed 53 cases from 5 states.

FDA has confirmed that some liquid docusate products have been contaminated with an organism known as Burkholderia cepacia. The organism has been linked to an outbreak in five states. B. cepacia is a group of bacteria found in soil and water, is often resistant to common antibiotics. According to CDC, the effects of B. cepacia on people vary widely, ranging from no symptoms at all to serious respiratory infections, especially in patients with cystic fibrosis.

Over the weekend, FDA announced that one of the manufacturers of docusate liquid, PharmaTech LLC, Davie, Florida, has voluntarily recalled their product. However, FDA has received several adverse event reports of B. cepacia infections in patients manufactured by companies other than PharmaTech. FDA and CDC continue to investigate the extent of this issue in order to identify potentially contaminated liquid docusate sodium products by other manufacturers. Hospitals that have received this alert have stopped using oral liquid docusate products.

FDA and CDC are recommending that clinicians not prescribe any liquid docusate sodium product as a stool softener or for any other medical purpose. Although this situation poses little risk to healthy people, patients with weakened immune systems are vulnerable to infections. Until more information is available, I recommend not using liquid docusate products for critically ill patients, those on ventilators to support respiration, or immunosuppressed patients.

Laboratories are being alerted to the possibility of B. cepacia infections, and being asked to report cases to state or local public health authorities. FDA and CDC will provide additional information when it is available.