Clusters of infections linked to the use of eye drops have been found in four states, according to US health officials tracking the outbreak that’s already led to the death of one person.
(Bloomberg) — Clusters of infections linked to the use of eye drops have been found in four states, according to US health officials tracking the outbreak that’s already led to the death of one person.
At least 35 of 56 cases related to the recalled eye drops have been reported from California, Connecticut, Florida and Utah, according to US Centers for Disease Control and Prevention spokesperson. Eight other states have also tallied infections, the CDC said, with some leading to permanent vision loss.
Concern is rising about the outbreak among people who used artificial tears sold by closely held EzriCare LLC based in Lakewood, New Jersey, according to the CDC. Laboratory testing found drug-resistant bacteria in opened containers of EzriCare eye drops that matched the strain found in patients.
EzriCare did not immediately respond to a request for comment. The company isn’t aware of any testing that definitively links its product to the outbreak, but recommends that people discontinue their use of the eye drops, according to a statement.
Read More: US Regulator Asks Consumers to Stop Using Eye Drops Made in India
Seven New York patients have been linked to the outbreak so far, according to a state health department spokesperson. The department’s Wadsworth Center in Albany is assisting with the multi-state investigation, testing samples from seven states in the northeast, the spokesperson said in an email.
Patients have presented with a variety of conditions ranging from eye infections to blood poisoning, often called sepsis, the CDC said. The infections are caused by a rare strain of Pseudomonas aeruginosa bacteria that’s resistant to many commonly used antibiotics. The resistant strain had never been seen in the US until the current outbreak, the CDC said.
The tears are primarily available through health-care facilities that purchased the product via wholesale distributors, the CDC said. One patient reported buying EzriCare’s product at a Costco Wholesale Corp. store, the CDC said. Costco didn’t immediately respond to a request for comment.
The products were manufactured overseas by Indian firm Global Pharma Healthcare Pvt Ltd, which has initiated a voluntary recall of all unexpired lots of EzriCare’s Artificial Tears, as well as another product marketed by New York-based Delsam Pharma LLC. The CDC is testing unopened bottles to determine whether contamination may have occurred during the manufacturing process.
Contamination has yet to be found in Delsam’s products, a company spokesperson said in an email. Although Delsam and EzriCare share a manufacturer, the two brands have different production dates and lot numbers, the spokesperson said.
US regulators recommended the recall due to Global Pharma’s violations of current good manufacturing practice, including lack of appropriate microbial testing, formulation issues, and lack of proper controls concerning tamper-evident packaging, according to a statement from the US Food and Drug Administration. The agency also placed the Indian firm on an import alert list that prevents more products from entering the US, according to the statement. Global Pharma referred questions about the recall to EzriCare and Delsam in a statement on its website.
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The US outbreak is the latest health issue linked to products manufactured in India, whose multi-billion dollar drugmaking industry is buoyed by an abundance of cheap generic manufacturers. The World Health Organization said last month that it’s investigating the deaths of more than a dozen children in Uzbekistan that were linked to cough syrup made by firms in India.
US regulators are monitoring the situation for additional cases and other potential products of concern. The CDC and FDA recommend that patients stop using artificial tears from EzriCare and Delsam. Patients who have used the products should watch for symptoms of eye infection, which can include pain or discomfort, discharge, redness and blurry vision.
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