Regulatory Agencies Issue Fresh Alert On Circulation Of ‘Deadly’ Eye Drops

Concerns over circulation of eye drops that could cause blindness and death have persisted; three months after National Agency for Food and Drug Administration and Control (NAFDAC) issued an alert.

United States Centre for Disease Control and Prevention (CDC) had, on February 1, warned of an outbreak of a drug-resistant strain of bacteria, Pseudomonas aeruginosa, linked to artificial tear products.

It said 68 patients across 16 states were identified, and the most commonly reported artificial tear brand was EzriCare Artificial Tears.

“Five patients had permanent vision loss, while one patient died,” it added.

NAFDAC had, on March 21, 2023, also alerted Nigerians on recalled EzriCare and Delsam Pharma Artificial Tears.

The recall was contained in a public alert (No: 008/2023), signed by NAFDAC’s Director General (DG), Prof. Mojisola Adeyeye, in Abuja.

In a new development, last week, the United States Food and Drug Administration (FDA) warned: “Do not purchase or use Delsam Pharma’s Artificial Eye Ointment.”

The announcement, released Wednesday, adds to previous caution issued earlier, this month, for EzriCare Artificial Tears or Delsam Pharma’s Artificial Tears, due to potential bacterial contamination.

All three products were manufactured by the same company, Global Pharma Healthcare, based in Tamil Nadu, India.

The FDA faulted the company for multiple violations, including “lack of appropriate microbial testing” and “lack of proper controls concerning tamper-evident packaging,” and has banned imports to the United States.

The updated warning from the FDA did not give additional information about the over-the-counter eye ointment beyond potential bacterial contamination.

The NAFDAC DG said the eye drop was recalled in February, due to suspected contamination with Pseudomonas aeruginosa.

Other problems associated with the eye drop were permanent loss of vision, surgical removal of eyeballs, and a case of death with a “bloodstream infection”.

The CDC said anyone who has any of these three products should immediately stop using them and look for signs of infection, including discharge in the eye, discomfort, redness, and blurry vision.

“If someone has any of these symptoms, they should seek prompt medical care. At this time, CDC does not recommend testing of patients who have used this product and who are not experiencing any signs or symptoms of infection,” the agency said in a statement.

Meanwhile, two manufacturers of eye drops have recalled products over fears of contamination and sterility.

The FDA issued recall notices, last week, for eye drops made by Pharmedica and Apotex, after the companies said they were voluntarily recalling the products.

“Use of contaminated eye drops can result in risk of eye infections that could result in blindness,” Pharmedica said about some of its Purely Soothing 15% MSM Drops.

The company urged consumers to stop usage and return them to point of purchase.

(Guardian)