The overdose-reversal drug naloxone should be available as an over-the-counter medication to aid the national response to the opioid crisis, U.S. health...
WASHINGTON — The overdose-reversal drug naloxone should be available as an over-the-counter medication to aid the national response to the opioid crisis, U.S. health advisers said Wednesday.
Panel members urged the FDA to move swiftly rather than waiting for Emergent to conduct a follow-up study with the easier-to-understand label. The potential move represents the latest government effort to increase use of a medication that has been a key tool in the battle against the U.S. overdose epidemic that kills more than 100,000 people annually. The decades-old drug can counteract the effects of an opioid overdose in minutes.
FDA staff members flagged also cautioned that a number of participants had trouble following the directions, in part because of the way the multistep instructions were laid out across two sides of the carton, FDA noted. Community advocates and organizations that favor distributing the drug welcomed the potential approval of an over-the-counter version.
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