US stops India-made eyedrop import after infections | India News

A highly drug-resistant bacteria that was linked to eyedrops imported from India and that spread from person to person in a long-term care center in Connecticut, US, has prompted concerns that the strain could gain a foothold in US health care settings, according to the Centers for Disease Control and Prevention.
Specialists said the strain had not been previously detected in the US, and that it was particularly difficult to treat with existing antibiotics.
In recent months, three deaths, eight cases of blindness and dozens of infections have been traced to EzriCare artificial tears, according to the CDC, leading to a widespread recall this year.
The Food and Drug Administration, which regulates over-the-counter medicine, has stopped imports of the product. But these outbreaks highlight regulatory gaps in controlling imports of medications. The FDA confirmed that it had not inspected the factory where the eyedrops were made in India before the infections were reported, but that the agency had since visited the plant, which is operated by Global Pharma Healthcare.
The agency has long been criticised for lapses in inspections of manufacturing in China and India, which are the two major producers of drugs and raw ingredients for medicines. Other instances of contaminated products from overseas included blood pressure medications suspected of containing a possible carcinogen and deadly batches of heparin, both of which prompted mass recalls.
The FDA said it was continuing to work with the CDC and had urged retailers to make sure the products were removed from shelves.
In the latest instance, the eyedrops are linked to bacteria that is even more drug-resistant than a similar bacteria that the CDC tends to see in about 150 cases per year, mostly in intensive-care settings, according to Maroya Walters, lead investigator for the CDC’s antimicrobial resistance team.
The bacteria showed signs of spreading within the Connecticut center among asymptomatic patients who had the bacteria colonized in their bodies. Such spread tends to occur when patients touch common items or when health care workers transmit the germs. The bacterium linked to the eyedrops, drug-resistant Pseudomonas aeruginosa, is a top concern for health care providers. nyt

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