The CDC traced fatalities and instances of blindness to products imported from India, expressing concern that the bacteria might establish a presence in the United States.
April 3, 2023, 3:00 a.m. ET A bottle of EzriCare artificial tears is displayed alongside two unopened boxes of the product. Contaminated EzriCare artificial tears containing antibiotic-resistant bacteria have been associated with an outbreak that affected 68 individuals across 16 states. Among those affected, eight have lost their sight, four had an eye removed, and three have died. The Centers for Disease Control and Prevention (CDC) has raised concerns that a highly drug-resistant bacteria strain connected to eyedrops imported from India, which has spread among individuals at a Connecticut long-term care center, could establish itself in US healthcare settings.
According to infectious disease specialists, the strain has not been previously identified in the US and is challenging to treat with current antibiotics.
The CDC has linked EzriCare artificial tears to three deaths, eight cases of blindness, and numerous infections in recent months, resulting in a widespread recall this year.
Although the Food and Drug Administration (FDA) has halted imports of the product, the outbreaks underscore regulatory shortcomings in controlling imports of foreign medications.
The FDA acknowledged that it had not inspected the Indian factory where the eyedrops were produced prior to the reported infections but has since visited the facility, operated by Global Pharma Healthcare.
The agency has faced criticism for inspection lapses in overseas manufacturing, particularly in China and India, the two primary producers of drugs and raw ingredients for medications. Contaminated products from overseas have led to mass recalls in other instances, such as blood pressure medications suspected of containing a potential carcinogen and lethal batches of heparin.
The FDA is collaborating with the CDC and has urged retailers to make sure that the recalled eye care products are removed from shelves.
The eye drops are associated with a bacteria that is more drug-resistant than a similar strain that the CDC typically observes in around 150 cases per year, primarily in intensive-care settings, according to Maroya Walters, lead investigator for the CDC’s antimicrobial resistance team.
Dr. Walters expressed concern that the newest strain’s spread “could really change the outlook for that.”
The bacteria exhibited signs of spreading among asymptomatic patients at the Connecticut center who had the bacteria colonized in their bodies. This type of spread tends to occur when patients touch shared items or when healthcare workers transmit the germs.
Drug-resistant Pseudomonas aeruginosa, the bacterium connected to the eyedrops, is already a significant concern for healthcare providers, particularly among people who have compromised immune systems, patients with invasive medical devices like breathing tubes or catheters, and nursing home residents.
According to Dr. David van Duin, a University of North Carolina School of Medicine infectious disease specialist, resistant pseudomonas is particularly difficult to eliminate from healthcare facilities, where it clings to sink drains, water faucets, and other damp environments, and from patients who develop bloodstream infections. He stated that “It’s very hard to get rid of.”
According to Dr. Walters, thanks to a product recall and extensive media coverage, cases linked to the eyedrops have been largely contained. The FDA also announced the recall of Delsam Pharma’s Artificial Eye ointment, manufactured in the same factory as the eyedrops, due to potential contamination.
The CDC is urging doctors to collaborate with health labs to ascertain “the genetic fingerprint of hard-to-treat Pseudomonas infections in the eye and throughout the body.”
“I think we are going to see the impact of this play out over the course of months to years,” Dr. Walters said.
CONTACT PARKER WAICHMAN LLP FOR A FREE CASE REVIEW
To find out if you or your loved one can file a defective eye drop lawsuit, call Parker Waichman LLP for a free legal consultation. Call 1-800-YOUR-LAWYER (1-800-968-7529) to speak with our national eye drop injury lawsuit lawyers, and we will explain your rights and options. If qualified, our attorneys will work hard to obtain the financial compensation you or your loved one deserves.
.svg){kind=small}
.avif)
.avif)
