Global Pharma initiated a recall of eye drops in February following links to a strain of drug-resistant bacteria that contributed to a minimum of three fatalities. Subsequently, two additional companies also initiated eye drop recalls.
April 4, 2023, A man repositions his head to apply eye drops into his right eye. The Centers for Disease Control and Prevention issued a caution for individuals to cease using two specific eye drop brands associated with a drug-resistant bacterial strain. Angelika Warmuth/Picture-Alliance-DPA, via Associated Press In January and February, two eye drop brands were removed from the market after being associated with a strain of drug-resistant bacteria resulting in at least three fatalities and significant health complications in several individuals. Weeks following, two distinct eye drop products were recalled due to separate contamination risks.
This wave of recalls might lead you to question your go-to dry-eye solution; however, it’s important to note the differences between the recalls and the numerous precautions you can take for safety.
“I would urge everyone who utilizes eye drops to continue doing so, ensuring, of course, that they’re not using any of the recalled products,” stated Dr. Christopher Starr, a spokesperson for the American Academy of Ophthalmology in a clinical capacity.
Here’s what you need to understand about these recalls.
Which eye drops have been recalled?
In January, both the Centers for Disease Control and Prevention and the Food and Drug Administration cautioned individuals to stop utilizing EzriCare Artificial Tears and Delsam Pharma’s Artificial Tears. These products were associated with a drug-resistant variant of the bacteria Pseudomonas aeruginosa. Infections from this bacterial strain have resulted in at least three fatalities, vision loss in eight individuals, and the surgical removal of four people’s eyeballs.
In February, Global Pharma, the manufacturer of both EzriCare and Delsam Pharma’s eye drops, initiated a recall for both products.
In March, a Florida woman filed a lawsuit against Global Pharma, alleging that an infection triggered by the eye drops was so severe that a surgical procedure was required to remove one of her eyes.
The FDA has also cautioned individuals to cease using an eye ointment produced by Global Pharma due to potential contamination.
The two additional eye drop recalls were unrelated to the bacterial outbreak.
On March 1, Apotex recalled prescription eye drops intended for reducing eye pressure in individuals suffering from glaucoma or ocular hypertension. The company recalled six batches of Brimonidine Tartrate Ophthalmic Solution 0.15 percent due to at least four bottle caps showing cracks, which could compromise the product’s sterility.
On March 3, Pharmedica recalled two batches of Purely Soothing 15 percent MSM Drops due to lack of sterility. These drops are used for alleviating eye irritation and swelling.
As of March 14, the CDC reported that the drug-resistant bacterial strain associated with the recalled EzriCare and Delsam eye drops had been identified in 68 individuals across 16 states.
To determine if you possess eye drops included in the recall, it’s advisable to review the recall notice issued by each company. Each notice provides details on the affected product batch.
The notices for the EzriCare and Delsam eye drops, the Global Pharma eye ointment, the Apotex Brimonidine Tartrate, and the Pharmedica Purely Soothing can be found via respective links.
Seek medical attention if symptoms are present.
The CDC recommends that individuals who have used these artificial tears and are experiencing symptoms of an eye infection should promptly consult a physician. Symptoms may include yellow, green, or clear eye discharge, eye or eyelid redness, heightened light sensitivity, and discomfort or pain in the eye.
Apotex has suggested that individuals who received their recalled eye drops, which were distributed between April 5, 2022, and February 22, 2023, should get in touch with their healthcare provider and pharmacy. The company has also provided a contact number and a website for individuals to request a “recall/return packet.”
Jordan Berman, a vice president at Apotex, stated via email that the company had only identified four bottles with cracked caps. He mentioned that one of these bottles was reported by a customer, and the remaining three were found in retained samples — products the F.D.A. mandates a company to retain for situations like these.
“There have been no reports of adverse health outcomes related to this product,” Mr. Berman stated.
Pharmedica reported that, as of March 3, there were no reports of illnesses or other “adverse events” resulting from the use of the eye drops. The company did not specify the number of affected bottles or how the bottles became non-sterile.
Those experiencing issues with any of the recalled eye drops are advised to submit a report to the F.D.A. online, by mail, or via fax.
Dr. Barbara Tylka, an optometrist at the Mayo Clinic in Rochester, Minnesota, stated that, generally, eye drops are safe for use and many individuals rely on them to manage conditions such as dryness or irritation. According to Statista, a market research firm, about 117 million Americans used eye drops and eyewash in 2020.
To safely use eye drops, Dr. Tylka recommends that individuals use their own bottle and ensure it has not expired. Those who have been prescribed eye drops for procedures like cataract surgery should discontinue use once the healing process is completed, she said.
For the safe application of eye drops, Dr. Tylka advises individuals to use their non-dominant hand to “gently pull down the lower eyelid, look up slightly,” and then, with the dominant hand, place “that little drop in that lower cul-de-sac in the eyelid area.”
According to Dr. Starr, a professor of ophthalmology at Weill Cornell Medicine, mentioned that a common mistake is pressing the top of the bottle into the inner corner of the eye, which can contaminate the drops and scratch the eye’s surface. He stated that if he accidentally hits his eyelid or eyelashes with the bottle tip, he considers the bottle contaminated and either sterilize it again or replace it.
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