Almost 70 infections linked to recalled eyedrops in 16 states, CDC says

The bacterium Pseudomonas aeruginosa mutated over time to evade most treatments and had not been found in the U.S. until last year.

The deadly bacteria linked to recalled eyedrops causing infection and blindness had never been seen in the U.S. until 2022, according to the Centers for Disease Control and Prevention. It has since infected dozens of people and killed three. Even though the contaminated bottles have been removed from stores and healthcare facilities, the CDC expects more cases to be identified.

Infectious disease experts are most alarmed by how this bug — a well-known type of bacterium, Pseudomonas aeruginosa — has evolved in a way that is resistant to nearly all available treatments.

As of Friday, the CDC had identified 68 cases of a new strain of Pseudomonas aeruginosa in 16 states. The investigation is still underway, and the agency has to wait for states to report other cases.

More than half of the cases have been found in long-term healthcare facilities. Nearly all are linked to contaminated eyedrops that had been imported from India.

Pseudomonas aeruginosa has been around for years. In 2020, there were an estimated 28,800 drug-resistant cases in hospitals in the U.S., a CDC investigator not authorized to speak to the media said.

But the new infections revealed a form that had never before been reported in the U.S.: carbapenem-resistant Pseudomonas aeruginosa with Verona integron-mediated metallo-β-lactamase and Guiana extended-spectrum-β-lactamase.

The long name shows how its genes have transformed to make it more drug-resistant.

“This was a Pseudomonas original,” Dr. Robert Bonomo, a professor of medicine at Case Western Reserve University in Cleveland who has studied a variety of drug-resistant bacteria since 1990, said in an interview.

 

FDA staff report says data shows Pfizer’s Covid treatment Paxlovid is effective in high-risk adults

U.S. Food and Drug Administration staff on Tuesday said Pfizer’s clinical trial results on its Covid antiviral pill Paxlovid support the drug’s use in adults at high risk of progressing to severe disease.

The FDA staff made the conclusion in briefing documents ahead of a meeting on Thursday when external advisors on the agency’s Antimicrobial Drugs Advisory Committee will discuss whether to recommend full approval of Paxlovid for the treatment of mild to moderate Covid in high-risk adults.

At the meeting, advisers will consider evidence related to Paxlovid’s efficacy, and vote on whether the benefits outweigh the risks of using the drug. The FDA typically follows the advice of its advisory committees but is not required to do so.

The FDA authorized Paxlovid for emergency use in December 2021. Pfizer submitted an application for full approval of the drug in June 2022, and the FDA extended the review period of the application in December 2022. The agency is set to complete its review in May.

The meeting comes as companies like Pfizer and Moderna brace for a drop in sales of Covid vaccines and treatments that led to record revenues earlier in the pandemic. Sales of Paxlovid jumped to $18.9 billion in 2022, the first year it was available, but the company said it expects that revenue to drop 58% to $8 billion this year.