A highly drug-resistant bacterium that has been linked to eye drops imported from India and spread from person-to-person at a Connecticut care facility has raised concerns that the strain could gain a foothold in healthcare settings. United States, according to the Centers for Disease Control and Prevention.
Infectious disease specialists said the strain had not previously been detected in the United States and 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’s artificial tears, according to the CDC, leading to a widespread recall this year.
The Food and Drug Administration, which regulates over-the-counter drugs, has halted imports of the product. But these outbreaks highlight regulatory gaps in controlling drug imports abroad.
The FDA confirmed that it had not inspected the factory where the eye drops 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 criticized for failed inspections of overseas manufacturing in China and India, which are the top two producers of drugs and raw drug ingredients. Other cases of tainted products from abroad included blood pressure drugs 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 ensure products were removed from shelves.
In the latter case, the eye drops are linked to a bacterium that is even more resistant to drugs than a similar bacterium that the CDC tends to see about 150 cases per year, mostly in intensive care settings, according to Maroya Walters. , principal investigator of the CDC’s antimicrobial resistance team.
Walters said the spread of the newer strain “could really change the outlook.”
The bacteria showed signs of spreading within central Connecticut among asymptomatic patients who had the bacteria colonized in their bodies. Such spread tends to happen when patients touch common items or when healthcare workers spread the germs.
Eyedrop-associated bacteria is already a top concern for healthcare providers, especially among those with compromised immune systems, nursing home residents, and patients with invasive medical devices such as catheters and breathing tubes.