Press Room

State Health Officials, Medical Experts, and Safety Advocates Call on FDA to Seek Removal of Ultra-High Dosage Opioids

Arlington, VA (Aug. 31, 2017) — The Association of State and Territorial Health Officials (ASTHO), together with the Physicians for Responsible Opioid Prescribing, the National Safety Council, and the American College of Medical Toxicology, filed a petition today requesting that FDA seek removal of ultra-high dosage opioids from the market. The petition shows how the risks of these products outweigh their benefits. An example of an ultra-high dosage opioid is the OxyContin 80 mg tablet, which is equivalent to 24 regular strength Vicodin in one pill.

“ASTHO continues to work with state health leadership across the nation to combat the opioid epidemic,” says Mike Fraser, ASTHO’s executive director. “These ultra-high dosage opioids are extremely deadly when misused and we hope that FDA responds accordingly to our request to remove them from the market.”

The request for FDA to seek removal of these products comes on the heels of a report released last month by the National Academies of Sciences, Engineering, and Medicine (NASEM) calling on FDA to overhaul its opioid policies using a new framework that factors in misuse. Scott Gottlieb, the recently appointed FDA commissioner, enthusiastically endorsed the NASEM report and the new framework for making opioid approval and removal decisions.

State and territorial health agencies, along with partners across the nation, are working to prevent substance misuse and addiction, and working to educate providers on appropriate guidelines for treating pain.

In 2015, roughly 11.5 million Americans misused prescription opioids. The most common form of misuse involves borrowing opioids from friends or family to relieve physical pain. When an ultra-high dosage pill is taken by someone with a low tolerance to opioids, fatal respiratory depression can occur. Drug overdoses have become the leading cause of accidental death in the United States, surpassing motor vehicle accidents.

Pharmaceutical companies began introducing ultra-high dosage opioids about 20 years ago as the practice of prescribing long-term, high dose opioids became more common. In response to soaring increases in opioid addiction and overdose deaths, CDC and state health officials across the country are now urging the medical community to prescribe more judiciously and in lower doses when these medicines are indicated.

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ASTHO is the national nonprofit organization representing the public health agencies of the United States, the U.S. territories, and the District of Columbia, as well as the more than 100,000 public health professionals these agencies employ. ASTHO members, the chief health officials of these jurisdictions, are dedicated to formulating and influencing sound public health policy and to ensuring excellence in state-based public health practice.

Call ASTHO's main phone line at (202) 371-9090 or contact Jane Esworthy, (571) 318-5431. Follow us on Twitter.