A rare drug-resistant strain of bacteria found in recalled eyedrops has been linked to dozens of infections, vision loss, surgical removal of eyeballs, and even one death, according to a recent report by CNN. The recalled product, Global Pharma Healthcare’s Artificial Tears Lubricant Eye Drops, was distributed by EzriCare and Delsam Pharma and was first recalled in early February. The US Centers for Disease Control and Prevention has identified 68 patients in 16 states with infections of a strain of Pseudomonas aeruginosa that has never before been reported in the US. Most patients reported using artificial tears, with EzriCare Artificial Tears being the brand most commonly reported. The US Food and Drug Administration and CDC are urging consumers to stop using the recalled products immediately. Eye drop recalls have also been announced recently, although they aren’t linked to adverse events so far. These recalls highlight the importance of safe eye drop use, including using caution with preservative-free eye drops, washing hands before touching the bottle or the eye, avoiding touching the tip of the bottle to eyelashes and skin, and not using expired eye drops.
Important Details about Bacteria in recalled eye drops linked to cases of vision loss, surgical removal of eyeballs –
– A rare strain of bacteria found in recalled eyedrops has been linked to dozens of infections, as well as cases of vision loss, surgical removal of eyeballs and one death.
– 68 patients in 16 states of the US are infected with a rare strain of drug-resistant Pseudomonas aeruginosa that had never been reported before.
– EzriCare Artificial Tears was the brand most commonly reported.
– Adverse events reported include infections of the cornea, bloodstream, respiratory and urinary tract.
– FDA recommended the recall due to manufacturing violations.
– Pharmedica USA is recalling two lots of anti-inflammatory Purely Soothing 15% MSM Drops due “to non-sterility.”
– Apotex is recalling six lots of Brimonidine Tartrate Ophthalmic Solution 0.15% due to cracks in some bottle caps.
– Eye drops are safe when manufactured and used correctly.
– Patients should use caution with preservative-free eye drops, and other ways to prevent eye infections include washing hands before touching the bottle or your eye, avoiding touching the tip of the bottle to eyelashes and skin, and not using expired eye drops.
CNN — Rare Strain of Bacteria Found in Recalled Eye Drops Linked to Infections, Vision Loss, and Death
As of the first week of February, the artificial tears lubricant eye drops distributed by EzriCare and Delsam Pharma, both products of Global Pharma Healthcare, have been recalled due to bacteria contamination. This drug-resistant Pseudomonas aeruginosa —reported on March 14th by the US Centers for Disease Control and Prevention (CDC) — was never reported in the United States before, and was found in 68 patients across 16 states. Adverse events reported as of March 14th include infections of the cornea, bloodstream, respiratory and urinary tract. In addition, eight patients reported losing vision and four had to have their eyeballs surgically removed. At least one person has died. The CDC has urged consumers to stop using recalled products, and to seek medical care immediately if certain signs are detected.
The FDA had initially recommended recalling Delsam Pharma’s Artificial Eye Ointment over concerns of bacterial contamination; the company agreed to do so. Due to manufacturing violations such as a lack of adequate preservatives and microbial testing, FDA has also recommended the recall of EzriCare Artificial Tears, which was the most commonly reported brand of artificial tears used by patients affected by the bacteria-based infection. Global Pharma issued a voluntary recall last month. The company did not comment on the matter.
Pharmedica USA’s Purely Soothing 15% MSM Drops have also been recalled over non-sterility concerns. Meanwhile, Apotex has issued a recall to their Brimonidine Tartrate Ophthalmic Solution 0.15% over potential sterility issues caused by cracks in bottle caps that could lead to adverse effects. Although no adverse events have been reported so far with this product, Apotex still notes in the March 1st FDA announcement that they are recalling six lots of the prescription eye drops out of “an abundance of caution”. Pharmedica USA has not received reports of any adverse events or illnesses related to the product.
Dr. Thomas Steinemann is a clinical spokesperson for the American Academy of Ophthalmology. He notes that eye drops are usually safe when manufactured and used correctly. However, these recent recalls highlight the importance of safe eye drop use. Steinemann states that there are millions of individuals currently using eye drops safely for a variety of reasons. He stresses that for the average eye drop user, there is little concern and they shouldn’t stop using their eye medicines or even their over-the-counter products. Steinemann adds that patients should handle preservative-free eye drops such as EzriCare Artificial Tears with caution, as contamination can lead to serious infection. Most eye drops on the market have preservatives within them that serve to counteract the risk of contamination.
To prevent eye infections, individuals should wash their hands before touching the bottle or one’s eye. Eye drops that have expired should not be used. Additionally, the tip of the bottle should be avoided touching one’s eyelashes and skin.
As patients are urged to seek medical care and to refrain from using contaminated products, this recent outbreak highlights the importance of proper manufacturing and handling of pharmaceutical products.