The Food and Drug Administration will soon require prescription opioid manufacturers to include stronger language on the medications’ labels warning that higher doses and longer-term use carry risks including overdose and death.
The action, announced Thursday, comes nearly three months after a pair of FDA advisory committees met to discuss the results of two post-market studies of opioids that attempted to quantify the risks of long-term opioid use. And it comes nearly 30 years after the initial approval of OxyContin, the now-infamous painkiller sold by Purdue Pharma, whose aggressive marketing and oversupply helped drive the first wave of the opioid epidemic.
“The death of almost one million Americans during the opioid epidemic has been one of the cardinal failures of the public health establishment,” Marty Makary, the FDA commissioner, said in a statement. “This long-overdue labeling change is only part of what needs to be done — we also need to modernize our approval processes and post-market monitoring so that nothing like this ever happens again.”
The agency is also encouraging providers to use immediate-release opioid products when possible, and switching to extended-release products like OxyContin “only for severe and persistent pain that cannot be adequately treated with alternative options.” Notably, the FDA’s new labeling standards require drugmakers to include warnings that rapidly reducing doses or discontinuing opioid treatment altogether risks withdrawal symptoms, pain, and even suicide.
As the opioid crisis spiraled out of control, some prescribers became hesitant to treat patients’ pain with opioids, and in some cases, even hesitant to continue long-running prescriptions. But suddenly cutting patients off from prescription opioids often sends them into withdrawal, and can result in switching from legal medications to illegal opioids like illicit pills sold online or fentanyl.
The new labeling rules also require drug manufacturers to discuss medications used to reverse opioid overdose, like naloxone.
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The extent to which the FDA’s move will have a significant impact on public health is unclear. Opioids and the overdose crisis are seared into many Americans’ consciousness thanks to countless books and TV shows and continued media attention. Many have been directly affected, or have had family or friends who have been.
Annual opioid prescriptions in the U.S. are also down sharply from their peak over a decade ago, as American medical providers respond to the opioid epidemic and increased scrutiny of their prescribing practices. Deaths involving prescription opioids but not involving illicit substances, like heroin or fentanyl, have declined consistently since peaking in 2011, according to the National Institute on Drug Abuse.
In a recent interview, Makary, who is also a gastrointestinal surgeon, foreshadowed the move by referencing his own decision-making as a prescriber and citing OxyContin, which was approved without data supporting its long-term use.
“I feel terrible about the opioid epidemic: I personally prescribed opioids with misinformation,” Makary said in a July 11 interview with Bloomberg. “We’re going to look at the label for OxyContin and that class of medications and ask, ‘How can we ensure that it’s accurate and consistent with the science?’”
Accordingly, the FDA is removing the phrase “extended treatment period” from opioid labels, in an effort to avoid leaving the false impression that data exist supporting the medications’ use over the long term.
In a statement, the American Medical Association, which has previously opposed new requirements that physicians receiving training about opioid use disorder, applauded the FDA’s move, saying it emphasizes “shared decision-making” between patients and doctors.
“The AMA agrees that decisions whether to begin opioid therapy must be made on whether the benefits outweigh the known risks,” said Bobby Mukkamala, the organization’s president. “We agree that — if opioid therapy is indicated —physicians should start low and go slow. We further agree with the FDA that rapid escalations and rapid discontinuation should not occur to avoid patient harm.”
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