Consumer advocacy groups are petitioning the Food and Drug Administration (FDA) to ban high-dose opioids in yet another effort to curb the nation’s growing opioid epidemic. The petition aims to ban opioid pills and under-the-tongue films with a daily dose equivalent to more than 90 milligrams of morphine – a level deemed dangerous and debilitating to most patients by the Centers for Disease Control and Prevention (CDC).
The petition cites cases of toddlers and preschoolers who have accidentally ingested the pills and teenagers who have experimented with opioids – populations who would be less likely to overdose and die if high-dose opioids were banned.
“The existence of these products implies that they’re safe. They’re not,” said Dr. Andrew Kolodny, founder of the advocacy group Physicians for Responsible Opioid Prescribing. The petition points to the 80 mg dosage of OxyContin indicated for twice-daily use, which is the equivalent to 240 mg of morphine a day.
Opioid overdoses claimed the lives of more than 15,000 people in the U.S. in 2015 alone. Food and Drug Administration (FDA) Commissioner Dr. Scott Gottlieb has called the growing opioid epidemic his “highest immediate priority.” Both the FDA and the CDC have taken measures to limit prescribing of the drugs and warn consumers of the risks associated with use in an effort to slow the epidemic.
The FDA made no immediate comment to the petition but is expected to respond within six months.