“FDA is extremely concerned about the inappropriate use of opioids, which has reached epidemic proportions in the United States and has become a major public health challenge,” FDA commissioner Margaret A. Hamburg told reporters Tuesday.
At the same time, she added, “We must also recognize the medical value they have for many patients living with pain. Therefore, the agency must strike a balance between their benefit in treating patients with pain and the risks associated with misuse, abuse, addiction, overdose and death.”
Tuesday’s announcement marks the latest chapter in an ongoing, impassioned debate in the public health community about the proper role for opioids.
For years, doctors typically prescribed them only to patients in acute pain, such as cancer patients. But over the past decade, in part due to research generated by drug companies and pain specialists downplaying the risks of opioids, the prescription and use of painkillers skyrocketed, as they became a relatively common treatment for everything from back pain to arthritis.
With that increase has come an epidemic of addiction to the powerful painkillers, as well as a rise in their illicit use. A 2009 National Survey on Drug Use and Health found that about 2 million Americans were hooked on or abusing prescription pain relievers, numbers that eclipsed those for both cocaine or heroin.
The balance the agency tried to strike on Tuesday involves requiring new labels stating that the drugs are intended for the management of pain “severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.” The warnings, which will take effect in coming months, will say that because of the risks of addiction, abuse and misuse — even for patients who use the drug as directed — opioids should be used only for patients for whom other treatments are not sufficient.
That approach represents a departure from current labeling, which focuses more on the severity of patients’ pain rather than their conditions or the overall treatment they might need, said Douglas Throckmorton, deputy director for regulatory programs in the FDA’s Center for Drug Evaluation and Research. Current labeling recommends use for patients with “moderate to severe” pain.
Throckmorton said FDA officials hope the revised labeling will lead physicians and patients alike to be “more thoughtful and more careful” before using the powerful medications. “The goal here was to make every patient who taking an opioid and their prescriber have a long conversation about whether [the drugs] benefit them as individuals,” he said, adding, “This new labeling is also going to highlight some of the risks in ways we haven’t previously.”