Briefly, the PROP petition called for three changes to the drug labels of opioid pain medications. For non-cancer pain, these medications are currently approved for “moderate to severe” pain, and the proposed changes would remove the word “moderate,” leaving the drugs indicated only for non-cancer pain that is severe. In addition, the petition calls for the addition of a daily limit of 100 mg of morphine or equivalent per day, and a maximum 90 day treatment period.
Just recently, the FDA responded to the PROP petition and has granted some of the requests in the petition and denied others. While some of the FDA response is good news for chronic pain patients, there is still significant cause for concern that labeling changes to opioid painkillers may affect the ability of patients with chronic pain to access these medications.
The FDA declined to add daily dose limits or maximum treatment periods to the labels of opioids, stating that the current scientific literature does not support such limitations. It is good that the FDA recognizes that there are no data to support arbitrary daily dose or treatment period limits. However, the FDA is recommending label changes for some types of opioid painkillers, in order to provide more information about the risks associated with use of these medications, and to better describe the population in whom these drugs should be used.
Label changes will be required for long-acting or extended-release opioid medications (eg. MS Contin, Oxycontin, Fentanyl), rather than for immediate-release opioids (eg. Vicodin, Dilaudid, Percocet). The reason the FDA is targeting extended-release/long-acting (ER/LA) products with the labeling changes is that FDA feels that the risk for abuse and misuse is greater with these products, and higher doses tend to be used, creating additional risk for a fatal overdose. The boxed warning section of the label is to be changed, to highlight the risk of misuse, abuse, neonatal opioid withdrawal syndrome, addiction, overdose, and death.
In terms of PROP’s request to limit the indication for these medications to “severe” pain only, the FDA requires the following new language in the drug label:
“[Tradename] is indicated 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.”
And, in the Limitations of Use section:
“Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve [Tradename] for use in patients for whom alternative treatment options (eg. non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.”
These changes are cause for some concern, particularly because a judgement call will be required as to what exactly constitutes pain severe enough to require daily, around-the-clock treatment. And although physicians can and often do prescribe medications off-label, in the case of opioids, with the current regulatory environment, physicians may worry that off-label prescribing of opioids may be considered inappropriate, dangerous, and not the standard of care.
Then the question will become, who has pain severe enough to require daily opioid treatment? Many times patients with chronic pain conditions, especially women’s health conditions such as endometriosis that are misunderstood and often mismanaged, feel that their concerns about pain are not heard or taken seriously by their physicians. As an endometriosis patient myself, at times when I’ve been asked to rate my pain on a scale of 0 to 10, after giving my answer, I’ve been told that I must be wrong, and I’m not experiencing pain at the level that I say I am. I am concerned that it will be easy for physicians to tell patients that their pain is not severe enough to require daily opioid treatment based on what they believe to be true about the patient’s pain, rather than asking detailed questions about the disruption of daily life, and duration, quality and severity of pain, then listening to and believing the answers.
Pain is a difficult symptom to manage, especially when the condition from which the pain emanates is not fully understood, or in some cases, is not even recognized as real. Perhaps rather than investing time and capital resources into labeling changes of pain medications, physicians and patients would be better served if the FDA and other governmental agencies were to invest in understanding and developing treatments for the conditions that elicit chronic, untenable, pain.