Multiple eye-related illnesses have been connected to infected eyedrops brought into the United States (US) from India. The cases included one fatality and at least five with irreversible vision loss. The diseases were caused by the Pseudomonas bacterium, a drug-resistant pathogen that is endemic in several Indian hospitals.
The bacterium strain that caused the illnesses was identified in Florida, Connecticut, California, and Utah, and the Centers for Disease Control and Prevention (CDC) advised clinicians not to prescribe the EzriCare medication.
After the CDC’s public health notice, the US Food and Drug Administration (FDA) withdrew Global Pharma’s EzriCare eyedrops and Delsam Pharma’s Artificial Tears. Delsam Pharma’s Artificial Eye Ointment was later included in the recall.
Prior to the recall, the FDA had previously banned Global Pharma goods from entering the country owing to the company’s unsatisfactory response to an information request and concerns with its production practices.
The FDA has had difficulty inspecting factories in China and India, which supply the bulk of raw materials used in US pharmaceuticals. While the inquiry was dubbed a ‘public health victory’, it also shows the growing difficulties of addressing bacterial infections, that are growing increasingly resistant to medications.