FDA Sounds Alarm Post Eye Drops Link To Deaths In US, Production Suspended

SRINAGAR: Indian firm Global Pharma Healthcare is voluntarily recalling all lots of its artificial tears and lubricant eye drops after 55 adverse events, including one death and cases of permanent blindness, were reported in the US, American drug regulator USFDA said in a statement on Friday.

Brand named EziCare and Delsam Pharma, the eye drops in question — Artificial Tears Lubricant Eye Drops —are being distributed by EzriCare, LLC and Delsam Pharma. The recall has been attributed to possible microbial contamination.

In its product recall update today, the US Food and Drugs Administration (FDA), the country’s apex drug regulator, said the development followed an alert by the Centers for Disease Control and Prevention (CDC), US, about an investigation of a multi-state cluster of a potential drug resistant microbial infection linked to the eye drops manufactured by Chennai-based Global Pharma Healthcare.

“To date, there are 55 reports of adverse events, including eye infections, permanent loss of vision and a death with a bloodstream infection,” the USFDA said. In a warning, the FDA also cautioned consumers saying the use of contaminated artificial tears could result in the risk of eye infections that could lead to blindness.

“Artificial Tears (carboxymethylcellulose sodium) Lubricant Eye Drops, 10 mg in 1 mL, ½ fl oz (15 ml bottle), are used as a protectant against further irritation or to relieve dryness of the eye for the temporary relief of discomfort due to minor irritations of the eye, or to exposure to wind or sun. The product was distributed nationwide in the US over the Internet,” the FDA said. Global Pharma Healthcare is notifying the distributors of this product, Aru Pharma and Delsam Pharma, and is requesting that wholesalers, retailers and customers who had the recalled product should stop use, the FDA added.

A CDC probe, meanwhile, involves a multi-state cluster of Verona Integron-mediated Metallo-ß-lactamase (VIM)- and Guiana-Extended Spectrum-ß-Lactamase (GES)-producing carbapenem-resistant Pseudomonas aeruginosa infections possibly associated with the use of the artificial tears manufactured by Global Pharma Healthcare.

Drug resistant microbial contamination could be lethal in the wake of microbes in question becoming resistant to the treatment.

On October 5, 2022, the WHO had issued a global alert about potential links between sold and cough syrups manufactured by Maiden Pharma in Haryana’s Sonepat with over 66 child deaths in Gambia. On January 11 this year, the WHO issued a medical product alert on two substandard (contaminated) products, identified in Uzbekistan. The two products—AMBRONOL syrup and DOK-1 Max syrup—were being manufactured for exports to Uzbekistan by Noida-based Marion Biotech. The production at both Maiden Pharma and Marion Biotech remains halted. Sources said the eye drops in question were not sold in India.

Meanwhile, teams from the Central Drug Standards Control Organisation and the Tamil Nadu drug controller office would be inspecting the firm in Chennai tonight. In the past, the CDSCO acted quickly to shut operations at Maiden Pharma and Marion Biotech pending probe, even though the products were meant only for exports.