FDA advisers conclude that Narcan is safe to sell over the counter.

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The unusual unanimity of the vote “underscores the importance of making this medicine more accessible and also highlights the terrible risk of not acting to make medicine more accessible,” said Maria C. Coyle, chair of the advisory panel and an associate clinical professor at The Ohio State University College of Pharmacy.

The panel noted that in the last few years that NARCAN was deployed, some serious outcomes such as death were not directly linked to NARCAN, but were related to delayed application or issues involving other drugs.

The FDA encouraged companies to submit applications for over-the-counter naloxone; Emergent BioSolutions, maker of Narcan, stepped forward.

Several voting and nonvoting experts, including emergency responders, toxicologists, pharmacists, pediatricians and addiction medicine experts, said the proposed labeling and packaging of over-the-counter Narcan was in need of improvement. He suggested improvements to the company’s font, color choices, and pictograms intended to quickly guide Panic Helpers through the administration of the drug.

Such refinements were important, he said, also recommending that the instructions specify the number of doses. They also said the manufacturer had not evaluated whether young children could follow directions and give the medicine to siblings and parents. But the panellists emphasized that such adjustments should not hinder the release of urgently needed medicine.

Nevertheless, Dr. Leslie R. Walker-Harding, a panel member who is a pediatrician at Seattle Children’s Hospital, criticized the company for not enrolling people under the age of 15 in the study to see if children could easily understand if the drug could be used. How to do

“What a trauma it is for a child to see their loved one unconscious, dying, and not being able to do anything about it,” he said.

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