What is Diocto?
Diocto is a liquid stool softener that has been linked to Burkholderia cepacia bacteria (B. cepacia), a bacterial infection that lives in aqueous environments. People with weakened immune systems or chronic lung disease are most susceptible to contracting the infection, which can prove fatal for those inflicted. A multi-state outbreak prompted the Food and Drug Administration, as well as the Centers for Disease Control, to issue warnings to consumers and medical professionals. Shortly after, the manufacturer of the product issued a voluntary, nationwide recall of Diocto, in addition to all other liquid products manufactured by PharmaTech LLC.
Diocto Linked to the Death of an Infant
PharmaTech LLC is being sued by the parents of a 9-month-old child who died after being exposed to a contaminated stool softener in a Pittsburgh hospital.
The parents who live in Hampton, Pennsylvania, filed a federal suit in Pittsburgh courts in connection with the May 16, 2016 death of their daughter. She was just three months shy of her first birthday. She suffered from chronic lung disease due to severe acid reflux and other complications present at birth. She was administered a laxative to offset constipation, a common side effect of the pain medication she was on. Doctor’s were able to identify she had contracted a bacterial infection after she became lethargic but were unable to locate the source.
It wasn’t until after their daughters death that her parents learned of the Diocto recall, which was the same laxative she had been given in the hospital. The liquid stool softener was contaminated with B. cepacia manufactured in a PharmaTech facility in Davie, Florida.
FDA and CDC Launch Investigation and Nationwide Recall
The Centers for Disease Control first issued a report on the investigation of a multistate outbreak of B. cepacia infection in June 2016. In conjunction with the CDC report, the Food and Drug Administration issued a press release in July 2016 after the PharmaTech facility was linked to eight more illnesses in California and Maryland in connection to Diocto.
In August 2017, the FDA announced a nationwide recall of Diocto, which was primarily distributed wholesale to hospitals and retail facilities across the nation. It also issued a recall of all PharmaTech liquid products manufactured at the Florida facility, and distributed under the names Rugby, Major, Bayshore, Metron, Centurion and Virtus. Retailers and institutions were advised to immediately stop using and distributing the liquid products due to the risk of contracting the serious and life-threatening bacteria.
Varied Side Effects of B. cepacia
The Centers for Disease Control indicate the effects of B. cepacia vary from person to person, and range from no symptoms to serious respiratory infection. In particular, children with developing immune systems and patients with cystic fibrosis are at a higher risk of developing major health complications from exposure. The FDA press release indicates, “It [B. cepacia] can spread from person-to-person by direct contact and is often resistant to common antibiotics.”
Water System Tested Positive for Mold
PharmaTech shut down the facility in Davie and their phone line was disconnected as of November 3, 2017. B. cepacia bacteria lives in aqueous environments. A report issued by the FDA in 2016 referenced “black flakes” commonly associated with mold in the Florida facility. It’s water system did, in fact, test positive for mold and was most likely the cause of the subsequent distribution of a nationwide outbreak.