The Food and Drugs Authority (FDA) has cautioned the general public against the purchase and use of some specific eyedrop brands currently on the market due to its harmful effects.
According to the Authority, due to the contamination of these drugs the US Centre for Disease Control and Prevention (USCDC) has classified the incident as an outbreak. It explained that the USCDC has revealed that the eyedrops were found to contain the drug-resistant bacteria pseudomonas aeruginosa and is suspected to have led to three deaths and vision loss in eight patients.
“The Food and Drugs Authority (FDA) is alerting the public about a recent major incidence of contamination of two brands of eyedrops, EZRICARE ARTIFICIAL TEARS and DELSAM PHARMA’S ARTIFICIAL TEARS owned by Global Pharma. Global Pharma has since issued a voluntary recall of the products.”
Food and Drugs Authority
Contained in a statement signed by Dr. Delese Mimi Darko, FDA’s Chief Executive Officer, it indicated that due to the fact that the products are not registered with the Authority, they should not be commercially available on the Ghanaian market. However, the FDA advised the public who may be in possession of these drugs through other means to immediately stop using the recalled products, Ezricare Artificial Tears and Delsam Pharma’s Artificial Tears, and submit them to any of the FDA offices nationwide.
“Anyone who has used these recalled products and is experiencing any symptoms should contact a healthcare professional immediately. Reported symptoms include yellow, green, or clear discharge from the eye, eye pain or discomfort, redness, feeling of something in the eye, increase sensitivity to light and blurred visions.”
Food and Drugs Authority
Furthermore, the FDA assured the public that it is taking all necessary measures to ensure that only safe and effective medical products are available in Ghana. To this end, it encouraged the public to report any adverse effects or quality problems related to the use of medical products to the FDA through its MEDSAFETY APP.
Contaminated eyedrops recalled in the US
Meanwhile, a rare strain of bacteria found in recalled eye drops has been linked to dozens of infections, as well as cases of vision loss and surgical removal of eyes in the United States. This week, the US Centers for Disease Control and Prevention reported two additional deaths – a total of three have been linked to the bacterial infection.
Global Pharma Healthcare recalled its Artificial Tears Lubricant Eye Drops that were distributed by EzriCare and Delsam Pharma last month, and the agency has been warning people not to use the drops.
As of March 21, 2023, the CDC has identified 68 people in 16 states with infections of a rare strain of drug-resistant Pseudomonas aeruginosa never before reported in the United States. Most of the patients reported using artificial tears, the CDC said, and EzriCare Artificial Tears was the brand most commonly reported.
Reported adverse events include infections of the cornea, bloodstream, respiratory tract and urinary tract. There are eight reports of lost vision and four reports of surgically removed eyeballs.
On Wednesday, two case reports published in JAMA Ophthalmology offered more details about how these problems developed. One of the new case reports described a 72-year-old woman who lost vision in her left eye after using EzriCare artificial tears for dry eyes for about a week.
The woman went to the emergency room, where doctors discovered a large ulcer on her left cornea, nearly involving the entire eye. She was admitted to the hospital for three weeks, requiring IV antibiotics, antibiotic eye drops and multiple surgical interventions.
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