Prominent consumer watchdog groups are calling on federal drug regulators to issue an opioid recall for certain drugs, indicating that the risk of abuse and addiction associated with ultra-high dose pain killers exceeds the benefits.
A petition (PDF) was filed with the FDA on August 30, seeking the removal oral and transmucosal ultra-high dosage unit (UDHU) opioid analgesics from the market. Contributors to the petition include the American College of Medical Toxicology, the Association of State and Territorial Health Officials, the Coalition to End the Opioid Epidemic, the National Safety Council, and Physicians for Responsible Opioid Prescribing.
On August 1, FDA Administrator Scott Gottlieb and Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research (CDER), published an editorial in the Journal of the American Medical Association (JAMA) announcing that the agency would be assessing the risks and benefits of opioids. The FDA reviews would include the risks of opioid misuse.
The petition urges the FDA to consider UDHU opioids as carrying too high a risk for misuse and abuse. It specifically points to OxyContin 80 mg and IR oxycodone 30mg as examples of those that should be subject to an opioid recall, but notes there are others as well.
The consumer groups note that in 2015, an estimated 11.5 million Americans misused opioid drugs, which exposes them to the risk of life-threatening respiratory depression in the case of ultra-high dose versions of those drugs.
“UHDU opioids are especially dangerous when misused for recreational purposes or to experience the effect, a practice that is common among adolescents and young adults. In 2015, there were 969,000 youths aged 12 to 17 who misused prescription pain relievers, and 3.0 million young adults aged 18 to 25.5,” the petition notes. “An opioid naive adolescent who makes the mistake of experimenting with an UHDU opioid could easily suffer a fatal overdose. Experimentation with a low dosage opioid is also dangerous but less likely to lead to death.”
Data from the U.S. Centers for Disease Control and Prevention estimates that 142 Americans die every day from drug overdoses.
Drug overdoses kill more people in the U.S than gun homicides and car crashes combined. In fact, between 1999 and 2015, more than 560,000 people died from drug overdoses. Even as abuse has seemingly decreased, opioid overdose deaths have increased.
In 2015, two-thirds of drug overdoses were linked to opioids, including Percocet, OxyContin, heroin, and fentanyl, which on its own is largely driving the number of opioid deaths.
The epidemic is only worsening. Americans consume more opioids than any other country in the world. The amount of opioids prescribed in the U.S. last year was enough for every American to be medicated 24 hours a day for three weeks consecutively.
The governors of Arizona, Florida, Maryland and Virginia have declared states of emergency regarding opioid addiction crisis, while the Governor of Alaska has issued a disaster declaration.
In addition, drug manufacturers face a growing number of opioid lawsuits both from addicts and survivors of those who died from overdose, as well as from states who say the drugs were falsely marketed.
“When utilizing the new benefit-risk framework that takes into account inappropriate use, the need for removal of UHDU becomes even more clear,” the petition states. “UHDU opioids should be immediately removed from the market to prevent further harm to thousands of adults, adolescents, children and toddlers.”
The FDA has indicated that it is reviewing the petition.