Challenges of working in a grey area in a black and white world.
Posted Oct 26, 2013
The United States Food and Drug Administration (FDA) just announced that it has approved the first single-entity (meaning it is not combined with another pain reliever such as Tylenol), extended-release formulation of hydrocodone (the generic name for the drug most people know as “Vicodin). It is indicated for the treatment of pain severe enough to require around-the-clock long-term treatment, in a clinical setting where there are few treatment alternatives.
This is welcome news for practitioners and patients, as more treatment options are always welcome; patients are individuals, and do not necessarily respond equally to a given therapeutic intervention. The chronic pain population is particularly enthused about this new treatment option; it is not to be used as simply an as-needed medication, but rather as a routine part of ongoing pain management.
There had been concern on the part of some regulatory authorities that the potential for abuse with this new addition to the pain medication armamentarium might be higher due to the absence of Tylenol in the formulation. One can appreciate the juggling act that is ongoing when it comes to how we as a country and a medical profession confront the medical treatment of chronic pain, and the different philosophies as to how to prevent the abuse of the medical treatment of chronic pain.
And in fact this approval comes on the heels of last month’s FDA ordering of class-wide label changes for long-acting opioids, aimed at limiting the use of these drugs to patients with severe, refractory pain. Many see the Agency’s recent actions as demonstrating its commitment to chronic pain treatment, while continuing to grapple with the ongoing and deadly prescription painkiller epidemic.
The label clarification will address the risks of abuse and death, reinforce the requirement for additional postmarketing studies of the long-acting opioid, and include a boxed warning highlighting the risks of neonatal opioid withdrawal syndrome. In addition, the FDA has been asked by advocacy groups to strike the word “moderate” from opioid labels associated with the treatment of chronic pain. It is hoped that the indication of “pain severe enough to require daily, around-the-clock, long-term opioid treatment for which alternative treatment options are inadequate” will foster meaningful—and potentially lifesaving –discussions of eligibility between health care providers and their patients.
My sense is that all involved parties are being reminded that long-acting opioid drugs should be considered a last resort for patients who have few or no options, the use of which might lead to addiction, abuse, or misuse, no matter the dose; this reality, coupled with the risk of morbidity and mortality with an overdose, illustrates for us all the challenges of working in what almost is by necessity a grey area in a black and white realm.
Whether the wording on a label accomplishes these worthy goals remains to be seen.