Eye drops linked to death: A Chennai-based pharmaceutical company has suspended the production of a line of eye drops from the US market. The step was taken after a US agency said they could be contaminated with a drug-resistant bacteria that have been linked to reports of permanent vision loss and one death from a bloodstream infection.
Teams from Central Drugs Standard Control Organisation (CDSCO) and State Drug Controller were visiting the Global Pharma Healthcare plant located about 40 km south of Chennai.
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Eye drop bottles being tested
The US Centers for Disease Control and Prevention (CDC) is testing unopened bottles of EzriCare Artificial Tears eye drops, manufactured by Global Pharma Healthcare. The US Food and Drug Administration (FDA) said it was restricting imports of products made by the company.
“FDA is warning 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. Using contaminated artificial tears increases risk of eye infections that could result in blindness or death,” the agency said on Thursday.
Earlier, Global Pharma Healthcare had issued a statement, saying the company “is voluntarily 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”.
Outbreak alert in US
Doctors in US have been alerted to an unprecedented outbreak of Pseudomonas aeruginosa, affecting at least 55 people across a dozen states. At least one person died after administering the eye drop, reports said.
A CDC spokesperson said at least five of the 11 patients who have had infections directly in their eyes, have lost their vision.
Pseudomonas aeruginosa can cause infections in the blood, lungs, or wounds. The germ is proving tougher to treat in recent times because of antibiotic resistance, it was reported.
The bacterium usually spreads to people in hospitals or other healthcare settings when they’re exposed to contaminated water or soil, where it typically lives, CDC said.
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