Urgent recall for popular soap over fears of DEADLY sickness that can cause organ damage

Daily Mail​

2 days ago

A skincare brand that markets antiseptic soaps to immunocompromised Americans and healthcare workers issued an urgent recall over risks of sepsis and organ failure from its products.
DermaRite Industries, LLC, based in New Jersey, found that several of its antiseptic cleansers were contaminated with the bacteria Burkholderia cepacia, a dangerous bacteria that preys on people with weakened immune systems, particularly those with cystic fibrosis (CF).
CF is a genetic disorder that causes severe lung damage and makes patients vulnerable to lasting infections. Around 40,000 Americans have the disease, with about 1,000 new cases diagnosed each year, mostly in children under two.
'In healthy individuals with minor skin lesions the use of the product will more likely result in local infections, whereas in immunocompromised individuals the infection is more likely to spread into [the] blood stream leading to life-threatening sepsis,' the FDA said.
B. cepacia resists most antibiotics, spreads easily through respiratory droplets from coughing or sneezing and can trigger a fast-moving, often fatal pneumonia called 'cepacia syndrome.'
Even CF patients with mild symptoms can develop this aggressive infection. About one in five people with CF who carry the bacteria will progress to severe illness, sometimes with life-threatening bloodstream infections.
In addition to people with cystic fibrosis, immunocompromised people who have sickle cell anemia, are being treated for cancer, and being treated for burns, are most at risk of severe infection caused by B. cepacia.
The products being recalled are sold under the brands DermaRite, DermaKleen, Dermasarra, Kleenfoam and Perigiene. They were were distributed both to consumers via Amazon and their website and to healthcare facilities, including hospitals and clinics
To date, DermaRite has not received any reports of infections linked to their products and it has not been revealed how the products became contaminated.
The FDA recommends that people and stores that received shipments of the products 'examine available inventory and destroy all affected products.'
DermaKleen is an antiseptic hand soap with Vitamin E that reduces skin bacteria.
DermaSarra relieves itching from minor skin irritations like dryness, insect bites, or sunburn. KleenFoam is an antimicrobial foam soap with aloe vera for handwashing after diaper changes, caring for the sick, or before medical contact.
PeriGiene is an antiseptic cleanser designed for perineal hygiene.
'Burkholderia Cepacia Complex in these products may result in serious and life-threatening infections,' the FDA said.
Scientists call B. cepacia the 'chronic colonizer,' because once it infects the lungs of someone with CF, it persists for life, resisting antibiotics and the body's immune system.
It can evade treatment with most common antibiotics, but some, including Bactrim, meropenem, or ceftazidime, have been shown to be effective.
But there is no established, universal treatment for the infection. Doctors typically combine oral antibiotics to those administered through an IV. Even then, success is not guaranteed.
The bacteria sickens around 20 percent of CF patients. It can spread throughout the body and cause Cepacia syndrome (CS), a severe form of pneumonia that kills lung tissue with a mortality rate approaching 75 percent.
In some cases, it can spread beyond the lungs, resulting in multi-system organ failure and death.
The bacteria can spread from person to person through droplets emitted when a person coughs or sneezes. It can contaminate medical equipment in hospitals, while also appearing in moist areas in the home, including sinks and humidifiers.
From 2004 through 2021, there have been four recalls of nasal sprays that infected patients in the ICU, and a recall mouthwash that caused a cluster of pneumonia. It was also found in a liquid stool softener and an ultrasound gel that affected multiple batches and was recalled.
Most healthy individuals will never know that they were infected with this bacteria.
But case studies of B. cepacia infections in immunocompromised patients describe severe respiratory distress causing shallow breathing and low oxygen saturation.
Patients have also exhibited cracking sounds in their lungs, indicating aggressive infection there, potentially leading to respiratory failure.
Early signs of sepsis include fever, a rapid heart rate, fast or shallow breathing, and confusion.
As sepsis advances, it causes severe chills and sweating, extreme weakness, low blood pressure, pale skin, and high white blood cell counts.