FDA Set to Change Opioid Labeling

Extended-release opioids will be indicated for severe, but not moderate, pain.


In response to growing concerns about the escalating problem of opioid painkiller misuse (including abuse, addiction, overdose and death), the U.S. Food and Drug Administration (FDA) announced this week it is changing labeling requirements for extended-release and long-acting formulations of the prescription medication.

Opioids – which include morphine (Avinza, Oramorph SR, etc.), oxycodone (OxyContin, Percocet, etc), and hydrocodone (Vicodin, Lorcet, etc.) – change the way patients perceive pain, by keeping cells from transmitting pain signals. Sometimes the pain is acute (such as post-surgical pain or pain from a broken bone) and sometimes it is chronic (such as joint pain from osteoarthritis and rheumatoid arthritis). They are available as pills, liquids and skin patches.

The use (and misuse) of opioid pain relievers has skyrocketed over the last decade. A report from the Centers for Disease Control and Prevention (CDC) released in July notes that there has been a 300 percent increase in sales of the drugs between 1999 and 2010. Deaths in that same period increased fivefold for women and 3.6 times for men, and emergency room visits relating to overdose more than doubled among women between 2004 and 2010.

This labeling change does not affect immediate-release formulations of opioids – such as hydrocodone – which are more widely used.

According to the FDA website, “extended release and long-acting (ER/LA) forms pose a greater safety concern because – as their names suggest – they produce their effects for a longer period, and many contain higher doses compared with immediate release or opioid/non-opioid combination products. They include, to name a few, long acting versions of opioids such as morphine, oxycodone, and fentanyl.”

Current labeling of these ER/LA medications – which are often used for chronic pain – indicates they can be prescribed for "the relief of moderate to severe pain in patients requiring continuous, around-the-clock opioid treatment for an extended period of time.”

But under the change, which is expected to go into effect by December, the drugs will be indicated only for the most severe pain not helped by other medications.

“The new labeling language underscores that patients in pain should be assessed not only by their rating on a pain intensity scale, but also based on a more thoughtful determination that their pain – however it may be defined – is severe enough to require daily, around-the-clock, long-term opioid treatment, and for which alternative treatment options are inadequate,” explains FDA spokesperson Morgan Liscinsky.

The new labeling requirements will also highlight more prominently and in more detail the risk of neonatal opioid withdrawal syndrome (NOWS), which occurs after a baby has been exposed to these drugs while in the womb.

Additionally, the agency is also requiring the drug makers to conduct more studies and clinical trials (called postmarket studies) to better understand the risks and benefits of these medications over the long term.

Lynn Webster, MD, president of the American Academy of Pain Medicine calls the FDA’s decision thoughtful and scientifically based; he especially welcomes the requirement for studies on the drugs’ long-term safety and efficacy.

Dr. Webster says it’s also nice that the decision takes into account that some patients may still need these medications. “People with chronic pain that have severe enough pain to warrant an opioid should have access to it. There are hundreds of thousands of people with arthritis that may fall into that category. Not everyone with arthritis needs an opioid or may benefit from it. But for those in whom an opioid would provide relief, the decision by the FDA will allow that to continue,” he explains.

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