How officials solved the case of eye drops that blinded people

It’s amazing how the disease detectives pieced together this case, as the patients were scattered across the country for many months.

WASHINGTON. Patients have severely inflamed eyes. They could feel light, but they could see almost nothing else. The doctor called one case the worst eye infection he had ever seen.

This was the start of a national outbreak caused by extremely dangerous bacteria that some say marks an era when antibiotics no longer work and seemingly common infections spiral out of control.

At last count, 58 Americans in 13 states were infected, including at least one person who died and at least five people suffered permanent vision loss. All were linked to tainted eye drops, leading to a recall.

Experts admire the way disease detectives pieced together the case: the patients were scattered across the country. Illnesses arose within several months. Infections were found in different parts of the body – in some in the blood, in others in the lungs.

But scientists also shudder because they have long feared that common bacteria will evolve so that antibiotics will no longer work against them.

“It really shows us that this is not something theoretical and future. It’s already here,” said Dr. Louis Ostrosky, an infectious disease expert at the University of Texas Health Sciences Center at Houston.

This report is based on telephone and email interviews with disease researchers in the US, health officials in three states, and regulators in the US and India.

The investigation began in May in Los Angeles County, California. A patient who had recently been seen by an ophthalmologist presented with a severe eye infection. A month later, local health officials received a second report. Another severe eye infection, same optometrist.

Until the end of the summer, two more cases were reported in the county. The eyes of the patients were inflamed with profuse yellow pus, covering most of the pupil. Among the four, two had complete loss of vision in the affected eye.

The hospital that reported the first infection determined that it was caused by the bacterium Pseudomonas aeruginosa. The facility, which was equipped to conduct advanced genetic testing, quickly realized that the bacteria had a rare gene that protected them from the effects of commonly used antibiotics.

It was an early break for investigators, according to Kelsey Oyong of the Los Angeles County Department of Public Health.

OYong and her colleagues knew they were dealing with a dreaded microbe and notified the Centers for Disease Control and Prevention.

Pseudomonas infections are not new. According to the CDC, drug-resistant bacterial strains cause more than 30,000 infections among hospitalized patients in the US each year and more than 2,500 deaths. It can be spread through contaminated hands or medical equipment and is especially dangerous for debilitated patients with catheters or ventilators.

But the Californian infections were in the patients’ eyes, not more common stains like blood and lungs. In addition, laboratory analysis showed that the infection was caused by the microbe Pseudomonas, which can resist almost any antibiotic.

The only thing that helped was a new antibiotic called cefiderocol administered intravenously.

During the summer, outbreaks of Pseudomonas were observed in long-term care facilities in two other states.

In Connecticut, the first case was in June. In the end, the bacteria were found in 25 patients from five nursing homes across the state, said Christopher Boyle, a spokesman for the Connecticut Department of Public Health.

In Davis County, Utah, just north of Salt Lake City, the CDC reported the first of six cases in August. Although the patients had the bacteria, no one actually got sick, according to Sarah Willardson of the Davis County Department of Health.

Los Angeles County health investigators have speculated that the cases may have been related to some sort of contamination of equipment in the eye doctor’s office.

But that suspicion was dispelled in early October, when genetic testing revealed that swarms in California, Connecticut and Utah were caused by the same strain of bacteria — a type of microbe never seen before.

“It made us start thinking it was some kind of product,” said Maroya Walters, the CDC official overseeing the investigation.

There were other reports of drug-resistant Pseudomonas throughout the year, including a man in Washington who died of a bloodstream infection.

Given the initial cluster in an ophthalmologist’s office in California, the researchers suspected an eye care product was the culprit, although this hypothesis was complicated by the fact that infections in long-term care facilities were mostly found in the lungs.

But it wasn’t impossible. The tear ducts drain into the nasal cavity, which leads to the lungs and can provide a route deep into the body.

In early November, investigators determined that most of the Connecticut infected patients had been given artificial tears, though it is not clear to whom and what brand they were given.

Then, on November 9, a Florida hospital contacted the CDC to report serious eye infections associated with the outpatient clinic. A review of artificial tear brands used in Connecticut, Florida, and Utah revealed one common product: EzriCare artificial tears, an over-the-counter product sold in the US by EzriCare LLC of New Jersey and manufactured in India by Global Pharma Healthcare.

Pseudomonas bacteria are “almost everywhere” in India, and drug-resistant microbes are common in many hospitals, said Dr. Gagandeep Kang, who studies microbes at the Christian Medical College in the same state as the Global Pharma factory.

In January, genetic sequencing confirmed that the cases in Florida were caused by the same strain of bacteria as the clusters in California, Connecticut and Utah. On January 20, the CDC urged physicians not to recommend the EzriCare product.

However, there was no retraction or wide public notice. Investigators had strong circumstantial evidence pointing to EzriCare drops, but did not get stronger evidence until more than a week after testing, bacteria were found in seven open bottles of EzriCare artificial tears in Connecticut and New Jersey.

In early February, CDC officials issued a public health warning and the FDA recalled EzriCare eye drops and Delsam Pharma artificial tears, another product made by Global Pharma. Last week, the recall was extended to include Delsam Pharma artificial eye ointment.

Global Pharma did not respond to email requests for comment.

A month before the first recall, the FDA blocked imports of Global Pharma products.

FDA spokeswoman Audra Harrison said the US import ban was “not related to the outbreak” but was instead based on the company’s “inadequate response” to the documentation request and issues with its manufacturing procedures. She did not say what those problems were.

A follow-up recall was recommended due to a lack of microbiological testing and product formulation and packaging issues, she said.

The Food and Drug Administration (FDA), charged with ensuring the safety of drugs shipped to the US, has long failed to inspect facilities in China and India, which account for the vast majority of raw materials used in US drugs. A search of the FDA’s online inspection database turned up no records of facility visits by agency personnel.

Indian narcotics inspectors visited the plant and the country’s narcotics controller asked Global Pharma to cease production of all products related to the treatment of eye diseases until they complete their investigation, P.V. said. Vijayalakshmi, narcotics officer in the southern state of Tamil Nadu.

Ostrosky, an expert at the University of Texas, called the US investigation a “public health victory,” saying it shows that fighting drug-resistant bacteria requires international cooperation and investment. But he also said the case was discouraging.

An infection that would normally be easily treated with regular antibiotic eye drops “has become an infection that can be fatal and has little to no treatment other than one intravenous antibiotic,” he said.

Pseudomonas now joins a growing list of microbes, including the bacteria that cause urinary tract infections, which are becoming increasingly difficult to treat, Ostrosky added.

“It looks like a wave is coming towards us,” he said.

AP writers Matthew Perrone of Washington and Aniruddha Gosal of New Delhi contributed.

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