Indian company’s eye drops linked with 55 adverse events in U.S.
Why in news:
- Chennaibased Global Pharma Healthcare has recalled its eye drops from the U.S. market after U.S. government agency Centers for Disease Control and Prevention said that several people have suffered from adverse events that are possibly associated with the use of the product.
- The eye drops are not sold in India.
More on the news:
- The CDC had alerted the U.S. Food and Drug Administration (FDA) that to date, there were 55 cases of adverse events, including eye infections, permanent loss of vision, and one death with a bloodstream infection.
- The CDC was investigating a multiState outbreak of drugresistant infection cases, which it linked to the use of “Artificial Tears” lubricant eye drops.
- A warning is issued instructing consumers and doctors to not purchase and stop using the product.
Why it has been recalled:
- The FDA had recommended the recall due to manufacturing violations, including lack of appropriate microbial testing, formulation issues.
- The U.S. agencies were alerted while investigating an outbreak of a rare, drug resistant strain of Pseudomonas aeruginosa bacteria.
More about Pseudomonas aeruginosa bacteria:
Pseudomonas aeruginosa bacteria
- Pseudomonasis a type of bacteria (germ) that is found commonly in the environment, like in soil and in water.
- Of the many different types of Pseudomonas, the one that most often causes infections in humans is called Pseudomonas aeruginosa, which can cause infections in the blood, lungs (pneumonia), or other parts of the body after surgery.
- In 2017, multidrug-resistant Pseudomonas aeruginosacaused an estimated 32,600 infections among hospitalized patients and 2,700 estimated deaths in the United States.
How it is spread:
- Pseudomonas aeruginosalives in the environment and can be spread to people in healthcare settings when they are exposed to water or soil that is contaminated with these germs.
- Resistant strains of the germ can also spread in healthcare settings from one person to another through contaminated hands, equipment, or surfaces.