Diocto Stool Softener Recalled for Infection Risk

Diocto liquid and Diocto syrup laxatives have been recalled due to a possible contamination risk. The recall comes after the FDA received numerous reports of B. cepacia infections in people who had recently used Diocto stool softeners and laxatives.

The laxatives, manufactured and distributed by Rugby Laboratories, may have been contaminated with B. cepacia, an antibiotic-resistant bacteria that can cause pneumonia in immunocompromised people or those with lung disease. The products were distributed to both retailers and hospitals, and are being recalled voluntarily.pharmatech rugby brand recallSymptoms of B. cepacia infection are similar to those of pneumonia and include fever, cough, congestion, shortness of breath, and wheezing. Anyone who has used Diocto products and developed these symptoms should contact their doctor immediately, especially if they have compromised immune systems. B. cepacia infections are rare in non-compromised adults, but can be very dangerous because the infection is so difficult to treat.

The specific products being recalled are the 473 mL bottles of Diocto with lot numbers NDC 0536-0590-85 and NDC 0536-1001-85. Consumers should check the lot numbers on their Diocto products and throw them away if they match the recall.

Diocto Recalled Again for Infection Risk

Just one year after a previous recall, Rugby Laboratories is issuing another voluntary recall of their Diocto syrup laxatives and stool softeners.

Diocto Liquid, also known as docusate sodium, is a laxative given mainly to patients in the hospital recovering from heart attacks or surgery. The contaminated products were distributed to both retailers and hospitals.

Last year, Diocto products were recalled due to B. cepacia infections related to use of the laxative. Unopened bottles of the liquid laxative tested positive for the bacteria. All together, there were 60 infections spanning eight states. In last year’s case the manufacturer, PharmaTech, recalled all of their liquid products.

fda logo for recallB. cepacia is an antibiotic-resistant bacteria that can cause pneumonia, especially in the chronically ill. According to the FDA, “If a product contain B. cepacia, its use could result in infections in patients with compromised immune systems and in patients with chronic lung conditions such as cystic fibrosis.”

B. cepacia is commonly found in nature, mainly in water and soil. While it is unusual for healthy adults to become infected with the bacteria, such infections are difficult to treat and can be fatal in about 42% of cases.

After investigations following last year’s recall, the bacteria was found to have originated in contaminated water at PharmaTech, where the Diocto products were made.

High Mortality in Burkholderia Cepacia Complex Infections

B. cepacia, an antibiotic-resistant bacteria that causes pneumonia-like symptoms, has long been known to affect patients with cystic fibrosis. Recently, however, the results of a 17-year study have been published, showing how B. cepacia affects those without chronic lung diseases.

“Our work builds upon investigations performed by Dr. Krisztina Papp-Wallace at the Louis Stokes Cleveland VA Hospital investigating mechanisms of resistance in BCC [B. cepacia complex] and the clinical impact of infections caused by these pathogens in non-CF patients,” said Elie Saade, MD, a coauthor of the new study.

Focusing on infections acquired while in the hospital, the researchers looked closely at the epidemiology, treatment modalities used, and outcomes in cases of B. cepacia in the bloodstream. 248 patients over the age of 68 were studied. While none had cystic fibrosis, all were suffering from chronic diseases or severe acute illnesses.

Of the cases studied, 62% were facility-acquired infections with 41% having been associated with the placement of a central venous catheter, or central line–a procedure with a known risk of infection. In 20% of the cases studied, the patients developed pneumonia.

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 B. cepacia’s natural resistance to antibiotics. Only about 70% of the cases studied had any response to antibiotic treatment.

Researchers now have a good grasp how B. cepacia affects those without cystic fibrosis.The next step, Saade says, is to explore other options for treating the bacteria, for the benefit of patients both with and without the chronic lung disease.

Resources:
Texas Diocto® Lawsuit | Docusate Sodium Lawyer | Hastings Law Firm
Texas B. Cepacia Lawsuit | Burkholderia Cepacia Lawyer | Hastings Law Firm
A 17-Year Nationwide Study of Burkholderia cepacia Complex
Voluntary Nationwide Recall of all Liquid Products Manufactured by Pharmatech LLC

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