For the first time, the Food and Drug Administration (FDA) says it will consider allowing the over-the-counter sale of an overdose antidote as a way of curbing the rising death toll from drug overdoses each year.
The FDA along with the Centers of Disease Control and Prevention (CDC) and the Drug Enforcement Agency (DEA) gathered last month to discuss strategies to fight prescription drug abuse and misuse. A key topic was widening the availability of naloxone (Narcan), a nontoxic, non-addictive drug that can reverse the potentially fatal opioid overdose.
Some of the most misused prescription opioid painkillers include Oxycontin and Vicodin.
Naloxone is currently available as a nonprescription drug through limited sources, such as small, community-based programs that distribute the drug to people at high risk for drug overdose. Since 1996, 50,000 doses of naloxone have been distributed, and 10,000 overdose reversals have been reported.
The FDA is considering options for widening the availability of the drug, including offering a new formulation of the medication or making it available as an over-the-counter medication.
“We hope that by laying out the pathways and signaling our interest in working with groups interested in these issues, FDA can help to improve appropriate use and access to naloxone,” an FDA representative said in a statement.
Virtually hundreds of thousands of Americans are prescribed opioids each year. Whether they are taken legitimately or are being abused or misused, proponents of the plan say that widening the availability of naloxone has the potential to save thousands of lives each year.