The Food and Drug Administration has announced long awaited labeling changes for prescription opioid medicines – changes that adopt many of the demands made in a citizens’ petition that called for major changes in the prescription guidelines for narcotic pain relievers.
The biggest change is that long term opioids would no longer be indicated for “moderate” pain.
The FDA said it was changing the labeling on all extended-release and long-acting (ER/LA) opioid painkillers “to help health care professionals tailor their prescribing decisions based on a patient’s individual needs.”
The updated labeling will state that ER/LA opioids are indicated for the management of severe pain only — “pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.”
It was over a year ago that a group of doctors and public health officials, led by Physicians for Responsible Opioid Prescribing (PROP), petitioned the FDA to change the prescription guidelines for opioids.
Current labeling approves most opioids for “moderate to severe pain,” but the petitioners said that was an overly broad definition that encouraged physicians to prescribe powerful pain medications to patients who don’t really need them. They wanted the word “moderate” dropped from the labeling requirements, so that opioids would only be indicated for treatment of cancer pain and severe non-cancer pain.
The new FDA labels drop the word “moderate” and will say that ER/LA opioids should not be indicated for “as-needed” pain relief. However, doctors would still be able to prescribe opioids “off label” for moderate pain.
The new labels will also warn doctors and patients that, because of the risks of addiction, abuse, overdose and death, the drugs should only be prescribed for patients for whom alternative treatment options are ineffective or inadequate for pain management.
The FDA rejected a PROP demand that long term opioid therapy be limited to 90 days. An FDA letter to PROP giving its response in detail can be found here.
“These labeling changes describe more clearly the risks and safety concerns associated with ER/LA opioids and will encourage better, more appropriate, prescribing, monitoring and patient counseling practices involving these drugs,” said Douglas Throckmorton, MD, deputy director for regulatory programs in the FDA’s Center for Drug Evaluation and Research.
“This is a step in the right direction,” said Stuart Gitlow, MD, President of the American Society of Addiction Medicine, one of the original signers of the PROP petition.
“I think what we’ve got here is the beginning of a very slow movement toward utilization of these very strong opiates for only the most severe of cases, as opposed to their being utilized first-line for pain. But I don’t think we’re going to see any immediate changes in approach or utilization.”
The FDA will also require drug companies that make opioid pain medicines to conduct further studies to assess their risk of misuse, abuse, increased sensitivity to pain (hyperalgesia), addiction, overdose, and death.
In 2010, over 16,000 Americans died from painkiller overdoses, according to the Centers for Disease Control and Prevention. CDC officials say more than 70 percent of the overdose deaths were unintentional. In many cases, a combination of drugs was involved, such as painkillers taken with tranquilizers or alcohol.
“The FDA is invoking its authority to require safety labeling changes and postmarket studies to combat the crisis of misuse, abuse, addiction, overdose, and death from these potent drugs that have harmed too many patients and devastated too many families and communities,” said FDA Commissioner Margaret Hamburg, MD.
“Today’s action demonstrates the FDA’s resolve to reduce the serious risks of long-acting and extended release opioids while still seeking to preserve appropriate access for those patients who rely on these medications to manage their pain.”
Many chronic pain patients were fearful that the PROP petition, if implemented, would deny them access to opioid pain medicines.
Dr. Gitlow told National Pain Report that’s unlikely to happen.
“I’m fairly positive about the FDA’s implementation because they made changes in the wording, which hopefully will have some impact on those prescribers who don’t have quite the knowledge or expertise as others. And it won’t tie the hands of those doctors who are both very comfortable and very skilled in their utilization of these medications,” Gitlow said.
“The FDA’s decision shouldn’t have any impact on those patients who are receiving long term high dose opiates with good effect. In other words, if they genuinely feel better, have functional improvement, have minimal breakthrough pain, have few side effects, and are responding better to this treatment than they were to alternative measures, then by all means they should stay on the medication.”
But Dr. Lynn Webster, President of the American Academy of Pain Medicine, fears some physicians and health insurers may over-react to the FDA decision.
“I fear that payers will use this as an excuse to deny treatment to people who need the medications. I hope someone will be monitoring this,” Webster said in an email to National Pain Report.
“It is unclear how the FDA decision will impact the safe use of ER/LR formulations. Physicians may only prescribe to people with ‘severe’ pain, (but) that doesn’t mean it will be used as directed. People in severe pain often use more opioid than prescribed to escape their insufferable pain. Limiting the label indication will not prevent this from happening. Reducing harm from opioids requires much more than a change in label. I am doubtful this will have much impact.”
Webster said he was pleased that the FDA will require drug makers to conduct post-marketing studies on the effectiveness and safety of ER/LR opioid formulations. Webster said that was “long overdue”.