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

WASHINGTON, Aug. 31, 2017 /PRNewswire-USNewswire/ -- On August 31, International Overdose Awareness Day, the Association of State and Territorial Health Officials (ASTHO), Physicians for Responsible Opioid Prescribing (PROP), the National Safety Council (NSC), and the American College of Medical Toxicology (ACMT) filed a petition today requesting that FDA seek removal of ultra-high dosage opioids from the market. According to their petition, the risks of these products outweigh their benefits. An example of an ultra-high dosage opioid is the OxyContin 80mg tablet, which is equivalent to 24 regular strength Vicodin in one pill.

In addition to ASTHO, PROP, ACMT, and NSC, the petition was signed by FED UP! and Shatterproof. FED UP! is sponsoring dozens of demonstrations across the country today calling for more forceful action on the opioid crisis from FDA, Congress and the Trump Administration. FED UP! demonstrations include an evening vigil in Washington DC and a march to the White House.

The removal request comes on the heels of a report released last month by the prestigious National Academies of Sciences, Engineering, and Medicine (NASEM) calling on FDA to overhaul its opioid policies. Dr. Scott Gottlieb, the recently appointed FDA Commissioner, enthusiastically endorsed the NASEM report and its recommendation for a new benefit-risk framework that considers misuse in opioid approval and removal decisions.

In 2015, 11.5 million Americans are estimated to have misused prescription opioids. When an ultra-high dosage pill is misused by someone with a low tolerance to opioids, fatal respiratory depression can occur. 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.

Pete Jackson, who lost his 18 y/o daughter Emily to an ultra-high dosage OxyContin tablet, endorsed the effort to remove ultra-high dosage opioids. "These products are just too dangerous, there's no need for them," he said. Dr. Andrew Kolodny, the Executive Director of PROP agreed, explaining that removal will not pose hardships because "opioids are available in liquid preparations, patches and suppositories for patients that might have problems swallowing more pills."

SOURCE FED UP! Coalition