Month: March 2023

On Wednesday, the U.S. Food and Drug Administration announced the approval of over-the-counter sales for Narcan, an overdose-reversing nasal spray. The FDA green light marks the first naloxone product approved for use without a prescription (only the 4-milligram dose of Narcan has been approved; other formulations, including higher dosages and injectable versions of naloxone, will continue to require a prescription.) Naloxone rapidly reverses the effects of an opioid overdose, including in situations where fentanyl is involved. According to the FDA, in the 12-month period ending in Oct. 2022, the United States recorded 101,750 overdose deaths, primarily from opioids including fentanyl.

FDA Commissioner Robert Califf said: “Today’s approval of OTC naloxone nasal spray will help improve access to naloxone, increase the number of locations where it’s available and help reduce opioid overdose deaths throughout the country. We encourage the manufacturer to make accessibility to the product a priority by making it available as soon as possible and at an affordable price.”

The decision allows the drug to be made available at drug stores, convenience stores, grocery stores, gas stations, and online shops. It’s not immediately clear when Narcan will be available for over-the-counter sale. The FDA said this timeline will be determined by the product’s manufacturer, Emergent BioSolutions, who said it will be available “by the late summer to account for manufacturing changes that will be implemented to support nonprescription packaging, as well as supply chain modifications.”

Emergent BioSolutions CEO Robert G. Kramer said in a statement: “Today’s landmark FDA OTC approval for Narcan nasal spray marks a historic milestone as we have delivered on our commitment to make this important emergency treatment widely accessible, given the alarming rates of opioid overdoses occurring across the country.”

Walgreens spokesperson Zoe Krey said it would offer Narcan later this year in stores and online: “Delivering access to this lifesaving medication that can reverse the effects of an overdose if administered in time is imperative, and Walgreens is already working with suppliers to bring this OTC medication to shelves.”

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The Vatican said Wednesday that Pope Francis has been admitted to a hospital in Rome after complaining of breathing difficulties in recent days, and have cancelled his meetings for the next two days. The Pope had appeared in relatively good form during his scheduled general audience Wednesday, though he noticeably grimaced while getting into and out of the “popemobile.” Francis’ audiences through Friday were canceled, and questions remained about the pope’s ability to participate in the Vatican’s Holy Week activities.

Vatican spokesman Matteo Bruni said the pontiff is being treated at the Gemelli hospital, where Francis underwent surgery in 2021. Bruni said in a statement: “In recent days Pope Francis has complained of some breathing difficulties,” adding that Covid-19 had been ruled out by the tests but the pope would “require a few days of appropriate hospital medical therapy.” Bruni confirmed that testing at the hospital had determined that Pope Francis has a respiratory infection, and concluded:  “Pope Francis is touched by the many messages received and expresses his gratitude for the closeness and prayers.”

Francis had part of one lung removed when he was a young man due to a respiratory infection; and he spent 10 days at the Gemelli hospital following the 2021 surgery for an intestinal narrowing, which included the removal of 13 inches of his colon.  He had also been using a wheelchair for over a year due to strained ligaments in his right knee and a small knee fracture. The Pope has said he resisted having surgery for the knee problems because he didn’t respond well to the general anesthesia during the 2021 intestinal surgery; but. now has said the knee injury was healing and he has been shown walking more with a cane of late.

Francis is due to celebrate Palm Sunday this weekend, kicking off the Vatican’s Holy Week observances: Holy Thursday, Good Friday, the Easter Vigil and finally Easter Sunday on April 9.

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