India’s “Artificial Tears” drops have caused dangerous consequences in the US
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The US Food and Drug Administration (FDA) warns against using Indian-made eye drops.
The Artificial Tears drug has been linked to an outbreak of drug-resistant bacterial infections that have led to side effects in at least 55 patients in the US, including blindness and even death, Reuters reports.
As of January 31, 55 patients in 12 states have been identified with infections linked to the use of artificial tears.
“Associated adverse events include hospitalization, one death from a bloodstream infection, and permanent vision loss from an eye infection,” – reported to the FDA.
An analogue of such eye drops (artificial substitute for tear fluid) is also sold in Ukraine, in pharmacies there is a Belgian-made drug called “Artificial Tears”.
The Authority said that the Artificial Tears eye drops, produced by the Indian company Global Pharma Healthcare Pvt Ltd, were produced with violations.
The drug company says it has voluntarily recalled batches of expired eye drops distributed in the United States by certain drug companies.
One, called EzriCare, said it had stopped further distribution and sale of the eye drops and was not aware of any tests that “conclusively linked” the bacterial outbreak to the product.
An Indian government source said federal and state drug regulators sent a team to the manufacturing plant where the drops were made.
“This is a contract manufacturing company that supplies drugs to the US market through others”, – the source said, adding that this particular drug was not sold in India.
It will be recalled that earlier the World Health Organization linked the deaths of children in Gambia and Uzbekistan to the use of Indian-made cough syrup.
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