Doctors, safety advocates and state health officials are formally calling on the Food and Drug Administration (FDA) to ban high-dose opioid painkillers across the country. In the midst of an ongoing addiction crisis, cutting back on accidental overdose deaths is their number one priority, CBS News reports.
Specifically, a formal petition filed late last week by leaders of the Association of State and Territorial Health Officials, Physicians Responsible for Opioid Prescribing, the National Safety Council and the American College of Medical Toxicology is asking federal drug regulators to ban all pain pills that when taken as directed would add up to a daily dose of more than 90 milligrams of morphine. According to the letter, this 90 milligram level is currently considered by the Centers for Disease Control and Prevention (CDC) to be dangerous for most patients, while failing to improve pain control or ability to function.
While the petition seeks a ban on many high-dose tablets and under-the-tongue films, it singles out Purdue Pharma’s Oxycontin 80 milligram tablet. Per the drugmaker, the pill is regularly prescribed to be taken twice daily, adding up to approximately 240 morphine-equivalent milligrams of opioids every day, well over the CDC’s recommended limit.
The petitioners claim that children who accidentally get their hands on prescription painkillers and teenagers who experiment with drugs would be far less likely to overdose and die if the high-dose pills were taken off the market. The letter also notes that more than 15,000 people died from overdoses involving prescription opioids in 2015—many of them from these higher-dose options.
OxyContin maker Perdue Pharma recently responded to the petition, saying scientific experts and the FDA should indeed discuss the issue, adding that it’s important to seek “the appropriate balance” of the treatment of severe pain while combating the ongoing addiction crisis. The American Academy of Pain Medicine also responded, arguing that a ban combined with current insurance restrictions on high-dose opioids could lead to the undertreatment of pain for a small number of patients.
FDA officials have thus far declined to comment on the letter. However, it’s important to note that in the past, the agency has been willing to ban certain drugs for their abuse potential. For example, in July, the painkiller Opana ER was pulled from the market at the FDA’s request following a 2015 outbreak of HIV and hepatitis C virus (HCV) in southern Indiana linked to sharing needles used to inject the prescription painkiller. FDA Commissioner Scott Gottlieb, MD, has also called the U.S. opioid epidemic his “highest immediate priority” in office.
The FDA is expected to respond to this latest opioid-related petition within six months.