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Multistate Outbreak of Burkholderia cepacia Infections Associated with Oral Liquid Docusate Sodium

Update October 14, 2016 – Final Update

According to a 10/12/16 FDA update, “Health care professionals may resume normal use of oral liquid docusate sodium not manufactured by PharmaTech.” Products manufactured by PharmaTech are distributed and labeled by six firms – Rugby, Major, Bayshore, Metron, Centurion, and Virtus.

See the full FDA update at http://www.fda.gov/drugs/drugsafety/ucm511527.htm.

Update August 19, 2016

At this time, CDC and FDA are continuing to investigate this issue. Additional updates will be posted as they become available.

Related Announcement: FDA issues an import alert for all drugs produced by Laxachem Organics in India

Update August 10, 2016

FDA released an updated statement including a voluntary recall of all of liquid products manufactured by PharmaTech and distributed by: Rugby, Major, Bayshore, Metron, Centurion, and Virtus.

Instructions and a product list are included in the announcements, which can be read at http://www.fda.gov/Drugs/DrugSafety/ucm511527.htm and http://www.fda.gov/Safety/Recalls/ucm515610.htm.

This issue remains under investigation. In addition to the above recall of all liquid products manufactured by PharmaTech, both FDA and CDC continue to recommend that clinicians and patients not use any brand of liquid docusate sodium product as a stool softener or for any other medical purpose.

To date, CDC has confirmed 60 cases from 8 states. 

Please direct questions to haioutbreak@cdc.gov.  Members of the media should contact the CDC Media Office at media@cdc.gov.

An update will be posted in approximately one week.

Update July 26, 2016

To date, CDC has confirmed 58 cases from 8 states.  Please direct questions to haioutbreak@cdc.gov.  Members of the media should contact the CDC Media Office at media@cdc.gov.

Update July 18, 2016

Case count corrected as of July 18, 2016. CDC has confirmed 49 cases from 5 states.

Update July 16, 2016

FDA has released a statement regarding a voluntary recall of certain liquid docusate products. The extent of this issue remains under investigation; therefore, both FDA and CDC continue to recommend that clinicians and patients not use any liquid docusate sodium product as a stool softener or for any other medical purpose.

Update July 14, 2016

Investigation Update

At this time, CDC and FDA continue to actively investigate this issue. CDC has confirmed 53 cases from 5 states. All recommendations detailed in the last update stand. We will provide an update to this announcement soon. Please direct questions to haioutbreak@cdc.gov. Members of the media should contact the CDC Media Office at media@cdc.gov.

Update July 8, 2016

Recommendations

CDC continues to work with FDA, health departments and multiple healthcare facilities to investigate a multi-state outbreak of infections caused by Burkholderia cepacia complex (also known as “B. cepacia complex”). At this time, CDC continues to recommend that clinicians not use any liquid docusate product as a stool softener or for any other medical purpose. This recommendation is now expanded to all patient populations. If an oral liquid docusate stool softener is medically necessary, alternative medicines should be used.

CDC urges healthcare providers and laboratories to remain on alert for infections caused by B. cepacia complex occurring among non-cystic fibrosis (CF) patients and should inform infection prevention staff immediately when these infections are identified. In addition, although infections caused by B. cepacia complex are known to occur among patients with CF, any clusters of such infections should be reported. Cases and clusters should be reported to state or local public health authorities. 

Facilities that identify infections caused by B. cepacia complex among non-CF patients or clusters of these infections among CF patients should sequester and save all docusate products used in the facility.‎‎
 

Investigation Update

To date, 47 B. cepacia complex cases have been confirmed by molecular typing to match one of two outbreak strain types identified from healthcare facilities in five states.  Reports of possible cases from additional states are currently being investigated. CDC has confirmed that two samples of unused oral liquid docusate product received from one of the affected hospitals have tested positive for B. cepacia complex. Further testing is being conducted to determine if bacteria from these samples match the outbreak strains.  FDA is currently testing multiple liquid docusate products that are epidemiologically linked to reported B. cepacia complex cases. To date, CDC has confirmed one product as having B. cepacia complex growth; however, because of epidemiologic links, CDC is concerned about potential contamination of multiple liquid docusate products, pending FDA’s ongoing investigation of shared ingredients in the products in question.

CDC will provide an update to this announcement by July 14, 2016. Please direct questions to haioutbreak@cdc.gov. Members of the media should contact the CDC Media Office at media@cdc.gov.

Update July 7, 2016

At this time, CDC and FDA are actively investigating this issue. Additional updates will be posted soon.

Update June 29, 2016

Preliminary information continues to indicate that contaminated oral ‎liquid docusate products might be related to B. cepacia complex infections in one state. At this time, there is no epidemiologic or laboratory evidence to suggest oral capsules or enemas are affected. Until more information is available, CDC continues to recommend that facilities not use any oral liquid docusate products for patients who are critically ill, ventilated, or immunosuppressed. Facilities that experience B. cepacia complex infections among non-cystic fibrosis patients or clusters of B. cepacia complex infections among cystic fibrosis patients should sequester all oral liquid docusate products.‎‎

Healthcare providers and laboratories should remain on alert for B. cepacia complex infections occurring among non-cystic fibrosis patients and should inform infection prevention staff when these infections occur.  In addition, clusters of B. cepacia complex infections among patients with CF should be reported when infection rates appear above endemic rates. Cases should be reported to state or local public health authorities. 
 

CDC will provide an update to this announcement by July 7. Please direct questions to CDC at haioutbreak@cdc.gov.

Update June 24, 2016

The Centers for Disease Control and Prevention (CDC) is collaborating with the Food and Drug Administration (FDA), multiple state and local health departments, and numerous healthcare facilities to investigate a multi-state outbreak of Burkholderia cepacia infections. These infections have occurred primarily in ventilated patients without cystic fibrosis and who are being treated in intensive care units. 

Preliminary information indicates that a contaminated liquid docusate product might be related to cases in one state.  Until more information is available, CDC recommends that facilities not use any liquid docusate products for patients who are critically ill, ventilated, or immunosuppressed. Institutions with non-cystic fibrosis patients in whom there are B. cepacia infections should sequester all liquid docusate products.

Healthcare providers and laboratories should be on alert for B. cepacia cases occurring among non-cystic fibrosis patients and should inform infection prevention staff when these infections occur. Cases should be reported to state or local public health authorities. 

Please direct questions to CDC at haioutbreak@cdc.gov.

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