FDA sounds alarm post eye drops link to deaths in US, Indian firm suspends production
2 min read . Updated: 03 Feb 2023, 11:12 PM IST
Premium- US FDA in its advisory, citing reports, has warned people that use of the EzriCare Artificial Tears may lead to permanent vision loss and one death from a bloodstream infection.
With US Food and Drug Administration warning consumers not to purchase or use Chennai's Global Pharma Healthcare made EzriCare Artificial Tears due to potential contamination, the firm on 3 February said it has suspended the production.
US FDA in its advisory, citing reports, has warned people that use of the eyedrop may lead to permanent vision loss and one death from a bloodstream infection.
Earlier this week, the Centers for Disease Control and Prevention sent a health alert to doctors, saying the outbreak included at least 55 people in 12 states. One died and at least five others had permanent vision loss, reported AP.
"As of January 31, 2023, CDC identified 55 patients in 12 states with infections that have been linked by epidemiologic and laboratory evidence to use EzriCare Artificial Tears. Associated adverse events include hospitalization, one death with bloodstream infection, and permanent vision loss from eye infections. CDC issued and alert recommending consumers stop using EzriCare Artificial Tears pending additional guidance from CDC and FDA," FDA said in its health advisory.
Meanwhile, FDA is collaborating with the CDC and state and local health departments too probe a multistate outbreak involving a rare, extensively drug-resistant strain of Pseudomonas Aeruginosa bacteria.
According to Insider.com report, Pseudomonas aeruginosa can cause infections in the blood, lungs, or wounds and the germ has been proving tougher to treat in recent times because of antibiotic resistance.
Usually the bacterium spreads to people in hospitals or other healthcare settings when they're exposed to contaminated water or soil, where it typically lives, according to the CDC.
The FDA informed that Global Pharma Healthcare in the meantime has recalled unexpired lots of EzriCare Artificial Tears and another product, Delsam Pharma’s Artificial Tears.
In another update, the FDA shared Global Pharma Healthcare's announcement where it said that it is recalling all lots within expiry of their Artificial Tears Lubricant Eye Drops, distributed by /EzriCare, LLC- and Delsam Pharma, to the consumer level, due to possible contamination.
The US regulator had made this recall recommendations 'due to the company's current good manufacturing practice (CGMP) violations, which include lack of appropriate microbial testing, formulation issues and lack of proper controls concerning tamper-evident packaging'.
The eyedrops issue is gaining momentum across the globe, as in 2022, India-made brand of cough syrups landed in trouble post dozens of deaths among children in Gambia and Uzbekistan.
With agency inputs.
