Diocto Liquid and Diocto Syrup (docusate sodium) has been voluntarily recalled by Rugby Laboratories due to a risk of bacterial infections with B. cepacia. The laxative is manufactured by PharmaTech LLC. It is typically prescribed for patients who are hospitalized and might be recovering from a recent surgery or a heart attack, where straining to have a bowel movement might be injurious. It is also used in patients who are on mechanical ventilators or are in intensive care, reports the Daily Hornet.
B. cepacia poses little medical risk to healthy people, but individuals who have certain health problems such as weakened immune systems or chronic lung diseases, especially cystic fibrosis, may be more susceptible to B. cepacia infections.B. cepacia is a known cause of infection in hospitalized patients, according to the Centers for Disease Control and Prevention (CDC).
The recall was issued by Rugby after the U.S. Food and Drug Administration (FDA) told the company about some adverse event reports of B. cepacia infections in patients that may be associated with Diocto Liquid or Diocto Syrup. The effects of B. cepacia on people vary widely, ranging from no symptoms at all to serious respiratory infections. The FDA specified high-risk patients in its warning, but said B. cepacia infections “can be serious or even life-threatening.”
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In August 2016, Rugby recalled all lots of Diocto Liquid after two unopened bottles tested positive for B. cepacia. The CDC confirmed 60 infections in eight states as well, among hospitalized patients who were given Diocto Liquid or other brands of liquid docusate sodium laxatives, according to the Daily Hornet.
The FDA warned physicians not to give patients any brand of liquid docusate sodium laxatives for any reason – but the products returned by October 2016, a short time after FDA investigators discovered a “direct link of contaminated water at PharmaTech to the multi-state B. cepacia outbreak.”
In 2005, the CDC was notified by several states of clusters of pneumonia and other infections caused by B. cepacia and associated with contaminated mouthwash.
In 2004, CDC was told of a voluntary recall of over-the-counter (OTC) nasal spray due to contamination with B. cepacia complex. In addition, in 2004, B. cepacia was linked to nosocomial infections among intensive care unit patients and associated with exposure to sublingual probes.
How the Bacteria May be Spread
According to the CDC, B cepacia can also be spread to susceptible individuals by person-to-person contact, contact with contaminated surfaces, and exposure to B. cepacia in the environment.
Burkholderia cepacia (or B.cepacia complex) is a bacteria that is found in water and soil. Infections have a 42 percent mortality-rate as it resists many antibiotics. B. cepacia mostly infects hospitalized patients who are already very ill, particularly cystic fibrosis patients on ventilators.
With cystic fibrosis (CF) there are problems with salt and water balance in the lining of the breathing tubes. This imbalance causes thick, sticky mucus. This mucus then traps bacteria, like Burkholderia cepacia, in the lungs making it had to clear. This can lead to infection and damage to the lung lining which then can lead to more mucus production and further trapping of Burkholderia cepacia.
cepacia complex can survive for long periods in water or disinfectants. Healthcare-associated outbreaks of B. cepacia complex infection have been linked to contaminated nebulized and intravenous medications and solutions, including compounded and commercially distributed products, skin care products, disinfectants, and to inadequate disinfection of reusable medical devices, reports antimicrobe.org.
cepacia complex emerged in the late 1970s as a cystic fibrosis respiratory pathogen, linked to accelerated decline in pulmonary functions and reduced survival, especially among those with more advanced lung disease or who had undergone lung transplantation., according to antimicrobe.org.
What are B. cepacia Symptoms?
Symptoms of B. cepacia infection are similar to the symptoms one would experience with any other bacteria. These symptoms include increased cough, congestion, difficulty breathing, and possibly fever. If “cepacian syndrome” develops, the symptoms will be very severe and include a high fever, reports Yale School of Medicine.
Legal Help for Consumers of Potentially Tainted Laxative
If you or someone you know has been affected by negative side effects of Diacto Liquid or Syrup Laxative, you may have valuable legal rights. Parker Waichman LLP offers free, no-obligation case evaluations. We urge you to contact our personal injury attorneys at 1-800-YOURLAWYER (1-800-968-7529).