(Eye)Drop Out of Sight
What led to the recent bacterial outbreak in the USA that infected 68 and resulted in the death of three patients?
Jed Boye | | 4 min read | Discussion
Some Big Pharma conspiracy theories revolve around the idea that large corporations operate nefariously, giving patients medications that are actively harmful. Although most such claims are baseless and founded on bogus (or zero) science, there are times when – through negligence, human error, or other unexpected factors – medications can do more harm than good.
In March 2023, the USA saw the peak of an outbreak of a rare, drug resistant strain of Pseudomonas aeruginosa (1) – a bacteria that has been associated with multiple types of infections, including those of the eye. It has affected 68 people in 16 states, with eight of those patients reporting vision loss, four requiring enucleation, and three dying (as of the most recent updates). A joint investigation by the US Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC) and state and local health departments has identified artificial tears as a common exposure for many of this patient group.
In particular, EzriCare Artificial Tears, Delsam Pharma’s Artificial Tears, and Delsam Pharma’s Artificial Eye Ointment (all manufactured by Global Pharma Healthcare Private Limited) seemed to be products of concern. Throughout February, the FDA and CDC issued several warnings to both consumers and health care practitioners, cautioning them against purchasing or using these products. Global Pharma Healthcare eventually issued a voluntary recall (2). Although a recall will hopefully curb infections, the number may still rise as some of those already identified as being affected, such as Clara Olivia, who ended up losing her eye last September, were first diagnosed with a Pseudomonas aeruginosa infection as early as spring 2022 (3).
The accounts of those affected are a hard read, especially Olivia’s who, when describing her experience of the months following her enucleation, said, “I cried constantly, asking why this happened to me. How could this have happened to me? I was searching for an answer: What happened to me? At what moment? How? When? What did I do? And to not have an answer, that is the most terrible thing.” It’s clear that blame does not lie with Olivia – or any of the other patients – so what went wrong?
Although the products, which could be bought over the counter before the recall, were intended to be sterile, a number of current good manufacturing practice (GMP) violations by Global Pharma Healthcare (including a lack of appropriate microbial testing, no adequate preservative for the multi-use bottles that the drugs were distributed in, and a lack of proper controls concerning tamper-evident packaging) resulted in contaminated products. For those infected by the eye drops, the impact has been devastating – but it could have been even worse if not for the efforts of doctors, such as those at Bascom Palmer, who used photodynamic antimicrobial therapy to inhibit the bacteria when antibiotics proved unsuccessful (4).
Global Pharma Healthcare’s negligence is frustrating and scary. And it highlights the damage that can be caused – and the lives that can be lost – when corners are cut and when patient safety is not the paramount concern, especially in an era of rising antimicrobial resistance.
Have any of your patients been affected by the Pseudomonas aeruginosa outbreak? Are you worried about the increased drug-resistance of microbes? Do you have any other thoughts about this outbreak? Please let us know in the comments below or drop us an email: [email protected].