Two types of over-the-counter eye drops that have been recalled in the US after being linked to bacterial infections, including one fatal case, have not been imported to Taiwan, the Food and Drug Administration (FDA) said yesterday.
The agency’s US counterpart on Thursday ordered the recall of EzriCare Artificial Tears or Delsam Pharma’s Artificial Tears, citing potential bacterial contamination.
Global Pharma Healthcare Private Ltd, which manufactures the product, is suspected of contravening production guidelines, leading to the contamination that caused a multistate outbreak involving a rare, extensively drug-resistant strain of the Pseudomonas aeruginosa bacterium, it said.
The US agency said it is working with the US Centers for Disease Control and Prevention and local health departments to investigate the outbreak.
Fifty-five cases linked to EzriCare Artificial Tears were as of Saturday last week identified in 12 US states, it said.
In Taipei, the FDA said that the outbreak poses no threat to Taiwan, as the drugs are not available in the nation.
Cheng Hsin General Hospital Department of Infectious Diseases director Lee Ming-cheng (李明政) said P aeruginosa is a “very malicious bacterium” that can spread rapidly via contaminated surfaces.
Infections are usually treated with antibiotics, Lee said, adding that the prognosis for cases is best if they start taking the medication within three days of contracting the bacterium.
Cases are documented in which people contracted the bacterium via contaminated contact lenses, Lee said.
Delayed treatment has lead to blindness in some of them, he added.
He said there have been clinical cases of P aeruginosa infection from contaminated surfaces, such as contact lens, and that delayed treatment on a case resulted in blindness.
Additional reporting by CNA
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