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Colace (Docusate) Liquid Recall

July 13, 2016

Please note that we are recommending that all patients using Colace (Docusate) liquid immediately stop taking it.  This affects liquid only.  There have been no reports of other forms (e.g. capsules) as having an issue.

There has been an outbreak of 47 cases of a bacteria called Burkholderia cepacia. This outbreak has been linked to liquid colace (docusate) used for constipation.  The main risk is those that have Cystic Fibrosis or those who are on a ventilator or have a tracheostomy, but the precaution applies to all patients, to be safe.

Burkholderia cepacia complex is a family of bacteria that can colonize and infect the breathing tubes of people who have Cystic Fibrosis (CF). Years ago it was thought that all Burkholderia cepacia were very dangerous for people with CF. This was believed because some people who were colonized with Burkholderia cepacia developed a very quick drop in their health and lung function. In fact, a number of people developed something called cepacia syndrome. Cepacia syndrome is a very dangerous, overwhelming infection that can cause severe, life threatening complications. Although cepacia syndrome occurs in some cases, we now know that not all types of Burkholderia cepacia are associated with this very dangerous complication. In fact, some forms of Burkholderia cepacia are no worse than some of the other bacteria that colonize the breathing tubes of people with CF. The biggest problem with Burkholderia cepacia is we do not know enough about it. What we do know is that it can get very resistant to antibiotics and it can cause a lot of lung damage.

Symptoms of Burkholderia cepacia infection are similar to the symptoms you would experience with any other bacteria. These symptoms include increased cough, congestion, difficulty breathing and possibly fever. If someone develops cepacia syndrome the symptoms will be very severe and include a high fever.