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

Update August 25, 2017

CDC is collaborating with the Food and Drug Administration (FDA), state and local health departments, and healthcare facilities to investigate recent outbreak of Burkholderia cepacia infections associated with exposure to liquid docusate.

FDA has released a statement regarding a voluntary recallexternal icon of multiple brands of drugs and dietary supplements manufactured by PharmaTech LLC and distributed by Leader Brand, Major Pharmaceuticals, and Rugby Laboratories, regardless of manufacture/expiration date. These medications are used in inpatient and outpatient settings.

The recall is due to risk of product contamination with B.cepacia and the potential for human infection. PharmaTech liquid docusate products were also implicated in an outbreak of B. cepacia infections in 2016. CDC does not currently suspect that docusate products manufactured by other companies contain B. cepacia.

B. cepacia complex is an environmental pathogen. It can live on surfaces and in water. Infections may be transmitted through lapses in infection control, including indirect contact via environmental surfaces. Person-to-person transmission is possible but less common. B. cepacia complex bacteria can grow in aqueous environments, can exhibit resistance to preservatives, and can cause contamination of liquid medications or other liquid products. This has led to healthcare-associated outbreaks of B. cepacia complex. Healthcare facilities should consider implementing contact precautions in the setting of an ongoing outbreak of B. cepacia to reduce the risk of transmission. For additional information on B. cepacia please visit: Burkholderia cepacia in Healthcare Settings.

If you suspect patient infection(s) possibly associated with a medical product, we encourage you to alert your local or state health department and submit a voluntary report to MedWatch, the FDA Safety Information and Adverse Event Reporting programexternal icon.

The product recall notice and list of products can be found here: Recall of all Liquid Products Manufactured by Pharmatech LLC and Distributed by Leader Brand, Major Pharmaceuticals, and Rugby Laboratoriesexternal icon.

FDA Press Release August 11, 2017: FDA warns of potential contamination in multiple brands of drugs, dietary supplementsexternal icon
FDA Alert August 8, 2017: FDA updates on 2017 Burkholderia cepacia contaminationexternal icon

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.htmexternal icon.

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 Indiaexternal icon

FDA released an updated statement including a voluntary recallexternal icon 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.htmexternal icon and http://www.fda.gov/Safety/Recalls/ucm515610.htmexternal icon.

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.

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.

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

FDA has released a statement regarding a voluntary recallexternal icon 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.

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.

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.

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

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.

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.