According to a news report published on FoxBusiness.com, the U.S. Food and Drug Administration (FDA) has issued a new warning to consumers about another eye product linked to a life-threatening bacterium. The recent eye drop bacteria outbreak has led to one death and cases of permanent vision loss.
Last week, federal officials advised consumers and medical professionals not to use or purchase Delsam Pharma’s Artificial Eye Ointment due to a risk of bacterial contamination. Delsam Pharma’s Artificial Eye Ointment is an over-the-counter eye drop product that Global Pharma Healthcare Private Limited manufactures. The company agreed to launch a recall of all lots of its Delsam Pharma’s Artificial Eye Ointment.
This safety recall announcement transpired only a few weeks after this manufacturer initiated a recall of certain lots of its EzriCare and Delsam Pharma’s artificial tears products due to possible bacterial contamination. That recall happened following a multi-state bacterial eye infection outbreak, according to the FDA.
As of February 21, 2023, 58 people in 13 states have been infected with “an extensively drug-resistant strain of Pseudomonas aeruginosa,” according to the Centers for Disease Control and Prevention.
One eye drop user tragically passed away after the Pseudomonas aeruginosa bacteria entered their bloodstream. Five other people who used the recalled eye drops suffered permanent vision loss due to eye infections. All of these victims reported using several different brands of artificial tears, and some even used several different brands. However, EzriCare Artificial Tears eye drops were the most commonly reported eye product connected with these eye infection cases.
The FDA’s initial recall blames Global Pharma’s failure to adhere to good manufacturing practices, such as formulation issues, a lack of appropriate microbial testing, and the lack of proper controls about tamper-evident packaging. The FDA also stated that “Using contaminated artificial tears increases the risk of eye infections that could result in blindness or death.” If you or a loved one used one of the recalled eye drop products and have signs or symptoms of an eye infection, contact your medical provider or seek emergency medical attention immediately.
The Centers for Disease Control and Prevention (CDC) is currently working with the Food and Drug Administration (FDA) and state and local health departments to investigate a multi-state outbreak of a highly drug-resistant strain of Pseudomonas aeruginosa. This strain, which has never been reported in the United States before, is called carbapenem-resistant Pseudomonas aeruginosa with Verona integron-mediated metallo-β-lactamase and Guiana extended-spectrum-β-lactamase (VIM-GES-CRPA). The outbreak has been linked to various types of infections, including eye infections.
During the investigation, it was discovered that artificial tears were a common exposure for many of the affected patients. This is a concerning development, as these types of infections are highly resistant to antibiotics and can be difficult to treat. The CDC and other agencies are continuing to investigate this outbreak and are working to identify the source of the infections and prevent further spread.
This outbreak serves as a reminder of the importance of proper infection control measures and the need for continued surveillance of antibiotic-resistant bacteria. Healthcare providers should remain vigilant and take appropriate precautions to prevent the spread of infections, including careful use of antibiotics and strict adherence to infection control guidelines. The CDC and other agencies will continue to monitor this situation and provide updates as new information becomes available.
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If you lost a loved one suffered harm due to a contaminated eye drops, you may have the right to seek justice and compensation for your damages. The national product liability attorneys at Parker Waichman LLP are here to help you understand your legal options and file your defective product lawsuit, if qualified.
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