In what might seem like a bad dream, the makers of Diocto Liquid are recalling their stool softening products again. Rugby Laboratories has issued a voluntary recall - the second in less than a year - of their product known as Diocto Stool Softeners. This product comes in liquid form, and the recall involves all lots currently on the market, and the products were distributed all over the country at hospitals and pharmacies.
The manufacturers of the product, PharmaTech LLC had sold the stool softening liquid under several brands Rugby, Major, Bayshore, Metron, Centurion, and Virtus.
Docusate sodium, or Diocto as it is commonly known, is given to patients who have suffered from heart attacks or trauma, have undergone major surgery and it has been given to women who have recently given birth. Stool softeners work by increasing the amount of water that gets absorbed into the intestines and helps to make stool soft so that it can pass without difficulty.
The first recall took place last summer when the presence of Burkholderia cepacia (B. cepacia) infections related to use of the laxative and stool softener products were reported. The unopened bottles of Dicto tested positive for the presence of B. cepacia, and it was later traced back to contaminated water in the plants where the product was made.
Burkholderia cepacia is a bacterial infection caused by antibiotic-resistant bacteria that bring about a variety of symptoms related to the lungs including coughing, wheezing, congestion, fever, and shortness of breath. However, the risk of death is high for people who suffer from complex immune conditions, such as cystic fibrosis or pneumonia, and those who already have an underlying health condition.
Interestingly enough, in a timely 77-year study that recently wrapped up, researchers found that up to 43% of cases of B.cepacia can be fatal for people with pre-existing conditions and mortality rates were much higher than they would have liked to see; as high as 36% in some cases. The researchers noted that the mortality rate for these infections was surprisingly high. Mortality was 16% at 14 days, 25% at 30 days, and 36% at 90 days. This is at least in part due to the natural resistance to antibiotics that is common with B. cepacia infections. Only about 70% of the cases studied had any response to antibiotic treatment. This makes treating the infections even more difficult.
In response to the recall, there are a number of lawsuits coming about. One law firm from Texas, Hastings Law Firm, is currently speaking with victims and their families of people who have suffered from the B. cepacia bacterial infection. Those that have been injured may be able to recover monetary loses and compensation from their injuries through a docusate sodium (Diocto) lawsuit.
The FDA is urging people to check their stool softeners at home to ensure they don’t have this product in their medicine cabinets and to contact the FDA if signs of infection do occur. The product is not currently being used in the United States in hospitals and pharmacies until further notice.