Should opioid prescriptions come with an antidote to treat overdoses?
The idea is being floated by Food and Drug Administration Commissioner Scott Gottlieb, M.D., who said he's seeking ways to increase access to naloxone and reduce deaths from opioid misuse.
The FDA will hold a two-day public meeting in December, asking external advisors from the FDA’s Anesthetic and Analgesic Drug Products and the Drug Safety and Risk Management Advisory committees to consider various options to increase naloxone availability.
That includes considering whether naloxone should be co-prescribed with some or all opioids, he said.
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"There is the potential for significant costs and burdens that may be associated with naloxone co-prescribing," Gottlieb said in a statement. "These include the direct economic costs to consumers and health systems. They also include practical considerations such as the need for manufacturing volume growth for naloxone, and the risk of drug shortages of this product that could come from a sudden spike in prescribing."
The number of opioid overdose deaths reached 42,249 in 2016, double the 21,089 opioid-related deaths in 2010.
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Gottlieb said the FDA also plans to discuss the potential development of over-the-counter naloxone at the upcoming meeting.