The U.S. Food and Drug Administration (FDA) said Thursday that it has restricted imports from an Indian health care company amid a multistate bacterial outbreak linked to recalled eye drops.
At least one person has died, five are permanently blind, and at least 55 cases have been identified as of Jan. 31 in the 12-state outbreak involving a rare and “extensively drug-resistant” strain of Pseudomonas aeruginosa bacteria, according to federal agencies.
The outbreak is linked to two artificial tears products, EzriCare Artificial Tears and Delsam Pharma’s Artificial Tears. Most patients have reported using the EzriCare Artificial Tears product prior to infection, according to a health alert issued by the U.S. Centers for Disease Control and Prevention (CDC).
The FDA placed Global Pharma Healthcare Private Limited on its import alert list on Feb. 2 to prevent its products from entering the United States. According to the agency, the company failed to comply with current good manufacturing practice requirements and didn’t provide “an adequate response to a records request” as it probed the outbreak.
EzriCare Artificial Tears is a preservative-free product dispensed in multidose bottles. A Jan. 20 report (pdf) by the CDC noted that the agency discovered that most of those infected had used the EzriCare Artificial Tears product before getting sick.
The CDC said it “identified the presence of the outbreak strain in opened EzriCare bottles with different lot numbers collected from two states.”
The specific strain behind the outbreak, VIM-GES-CRPA, is so rare that it has never been seen before in the United States. Testing of opened bottles of EzriCare eye drops from two different states showed bacteria matching the outbreak strain, but the source of contamination remains unknown.
On Thursday, the FDA issued a warning to consumers and health care practitioners “not to purchase and immediately stop using EzriCare Artificial Tears or Delsam Pharma’s Artificial Tears due to potential bacterial contamination.” The agency said that using “contaminated artificial tears increases risk of eye infections that could result in blindness or death.”
According to the CDC, cases are being investigated in California, Colorado, Connecticut, Florida, New Jersey, New Mexico, New York, Nevada, Texas, Utah, and Washington.
Recall
The artificial tears products were subject to the recall following multiple violations of manufacturing regulations by the company, including a lack of microbial testing and proper tamper-evident packaging controls.
The bacteria, which are found in water and soil, can also be on people’s hands, and tend to mostly affect people with lowered immunity in settings such as hospitals. They are usually resistant to most antibiotics.
“In addition to demonstrating carbapenem resistance, isolates in this cluster are resistant to ceftazidime and cefepime; the subset of isolates that underwent antimicrobial susceptibility testing for ceftazidime-avibactam and ceftolozane-tazobactam were also resistant to these agents,” the CDC’s Jan. 20 report stated.
The infection is particularly difficult for doctors to treat owing to resistance to multiple antibiotics. Symptoms of an eye infection include eye pain or discomfort; yellow, green, or clear discharge from the eye; redness; increased sensitivity to light; and blurred vision.
The CDC recommends that patients who have used EzriCare preservative-free artificial tears and experience these symptoms seek medical attention immediately.
Health care providers are encouraged to perform culture and antimicrobial susceptibility tests if patients report use of the product. Patients infected or colonized with VIM-GES-CRPA should be placed in isolation and use appropriate precautions.
The CDC does not recommend testing for patients who have used the product but are not experiencing any symptoms.