Groups seek ban on high-dose opioids citing overdoses
CHICAGO (AP) — Safety advocates and state health officials are formally calling on the Food and Drug Administration to ban high-dose opioid painkillers to prevent accidental overdose deaths among patients and people who abuse drugs.
A petition filed asks the FDA to ban opioid pills that, when taken as directed, would add up to a daily dose of more than 90 milligrams of morphine. The Centers for Disease Control and Prevention has said that level is dangerous for most patients and doesn’t improve pain control or the ability to function.
The petitioners claim toddlers and preschoolers who get their hands on the pills and teenagers who experiment with drugs would be less likely to overdose and die if the high-dose pills were off the market.
The petition was signed by leaders of the Association of State and Territorial Health Officials, Physicians for Responsible Opioid Prescribing, the National Safety Council and the American College of Medical Toxicology.
“The existence of these products implies that they’re safe. They’re not,” said Dr. Andrew Kolodny, founder of Physicians for Responsible Opioid Prescribing and an outspoken advocate for opioid reform.
The petition singles out the OxyContin 80 milligram tablet, which is taken twice daily, adding up to 240 morphine-equivalent milligrams. OxyContin maker Purdue Pharma did not immediately respond to a request for comment. The petition seeks a ban on other high-dose opioid tablets and under-the-tongue films.
FDA officials declined to comment on the petition but FDA Commissioner Dr. Scott Gottlieb has called the opioid epidemic his “highest immediate priority” and has been willing to consider abuse of opioids in evaluating their safety.