FDA rewrites opioid narcotic labels to tighten use for pain

The FDA has revised the labels of long-acting and extended-release narcotic pain relievers to indicate they are for patients with round-the-clock pain relief needs not met by other means.
The FDA has revised the labels of long-acting and extended-release narcotic pain relievers to indicate they are for patients with round-the-clock pain relief needs not met by other means.
(Rich Pedroncelli / Associated Press)

Patients should not be prescribed long-acting or extended-release opioid pain relievers unless they need daily, round-the-clock treatment of their pain that can’t be managed by any other means, the Food and Drug Administration has told physicians.

The new guidelines are to be included on the labels and patient information sheets of all prescription opioid pain relievers that dissolve slowly after taken.

Along with a call for new research aimed at identifying what doses and modes of use are most likely to harm patients, the revised labels are the latest step taken by the agency to stem a growing epidemic of opioid abuse and addiction in the United States.

They were announced Tuesday by FDA Commissioner Margaret Hamburg and the Obama administration’s drug czar, Gil Kerlikowske.


In redrafting the medications’ “indications for use,” the FDA aims to change the current practice of prescribing these powerful analgesics for use by patients on an “as needed” basis.

The new guidelines will not place formal new restrictions on prescriptions by physicians who treat patients for pain, but administration officials announcing the change made clear they hope to chasten physicians who prescribe the medications for anything other than ongoing, intractable pain.

Currently, the nonbinding physician prescribing guidelines issued by the FDA indicate that long-acting and extended-release opioid narcotics should be used for “moderate-to-severe” pain. The revision made by the FDA would not just remove “moderate pain” from the agency’s list of approved uses for the medications: It aims to get patients and their physicians to focus not only on levels of pain, but on how long it can be expected to persist and what alternatives exist to relieve it.

“The goal here was to make every patient taking extended-release and long-acting opioids to have a conversation about whether these products are helping them as individuals,” said Dr. Douglas Throckmorton, deputy director for regulatory programs at the FDA’s Center for Drug Evaluation and Research. “I hope this encourages physicians and patients to be more thoughtful and more careful as they use these medications.”

Physicians legally retain their broad latitude to prescribe long-acting and extended-release opioid narcotics “off-label” to patients when they judge such use to be medically warranted.

The FDA’s action does not change the labels or prescribing guidelines of fast-acting opioid pain relievers, which are often prescribed to patients following surgery or injury. Agency officials said they acted first to encourage more careful use of the long-acting and extended-release formulations because they pose a higher risk of abuse, addiction and overdose for patients.

The new steps come against the backdrop of opioid abuse and misuse that has been termed “epidemic” by the Centers for Disease Control and Prevention. In 2010, more than 12 million Americans reported they had taken opioid narcotics for purposes other than those approved by the FDA.

In 2008, deaths from opioid abuse overtook those associated with cocaine and heroin combined, reaching 14,800. In 2009, the misuse and abuse of prescription painkillers accounted for approximately 475,000 emergency department visits in the United States, a near doubling of such cases over 2004.


Officials said they have seen a sharp increase as well in the numbers of babies born in the United States who have been exposed to opioid painkillers in utero -- a condition that can result in painful and potentially life-threatening withdrawal symptoms in the early days of life.

The changes ordered by the FDA also encourage physicians to discuss the potential dangers of opioid medications to an unborn child when dealing with women of childbearing age.