Physicians' group seeks FDA label change to combat opioid misuse
"An increasing body of medical literature suggests that long-term use of opioids may be neither safe nor effective for many patients, especially when prescribed in high doses," says a petition filed with the FDA. The group, Physicians for Responsible Opioid Prescribing, says the "overly broad" label has helped foster the opioid crisis in the workers' comp and general health care systems.
The labels, they say, fail to limit opioid use to severe pain, do not include a time frame for use, and don't specify a maximum dose. "Unfortunately, many clinicians are under the false impression that chronic opioid therapy is an evidence-based treatment for chronic non-cancer pain and that dose related toxicities can be avoided by slow upward titration," the petition says. "These misperceptions lead to over-prescribing and high dose prescribing."
The FDA's labeling of opioids has come under fire as physicians and other experts address the opioid epidemic. Until several years ago, the label was not a problem.
"If you go back 15 or 20 years ago, it would have been unusual for a primary care physician to treat low back pain with long-term opioids. Most would have been appropriately concerned about addiction and about tolerance to the medication causing them to become less effective over time," said Dr. Andrew Kolodny, chair of the Department of Psychiatry at Maimonides Medical Center in Brooklyn and president of PROP. "The pendulum swung to where physicians were aggressively encouraged to prescribe opioids. They were misinformed about the ability of these medications to improve the quality of life and function."
Kolodny says a "very effective" campaign by drug companies encouraged physicians to prescribe opioids for chronic pain. "I'm sure many involved meant well," he said. "They truly believed opioids were safe and effective for long-term use, but there was really never any strong evidence to support this view."
Because of what PROP says is the "misinformation" that has been advanced, many clinicians still believe the best and most compassionate way to treat pain is through the liberal use of opioids. That has led to what Kolodny says is the crux of the opioid issue: an epidemic of addiction.
Disease of addiction.
"Many who are dying from overdoses have the disease of addiction," Kolodny said. "The question is how did they get addicted."
While some opioid addicts started as nonmedical, recreational users, many others began as legitimate pain patients.
"In terms of strategies, there are many different things that have to be done," Kolodny said. "One of the most important things you need to do, probably the priority, is you need an effort to prevent new cases of opioid addiction, prevent more people from becoming addicted ... to do this we need physicians to prescribe more cautiously."
Many physicians have been misinformed about the risks and benefits of opioids to treat pain, Kolodny said. He says drug companies are still encouraging physicians to prescribe more.
"They've been given incorrect information. Many believe the risks are less than they are and the benefits are greater than they are," Kolodny said. "The label change that we are requesting would prohibit drug companies from making claims that opioids are proven safe and effective for long-term use in chronic pain."
Opposition to petition.
While proponents of the FDA label change are a strong force, Kolodny expects pushback from drug manufacturers who stand to lose millions. Since any new indication for a medication is potentially worth tens of millions of dollars, drug companies typically are forced to produce scientific studies to prove the medications are effective for alternative uses.
"With opioids, they've never had to do that," Kolodny explained. "Because you've got this broad label, it means they can push opioids for fibromyalgia, low back pain -- whatever they want."
A label change by the FDA would prohibit drugmakers from promoting long-term use of opioids for chronic non-cancer pain, PROP says. It would communicate to the medical community that the practice has not been proven safe and effective.
At the same time, Kolodny says PROP members recognize that there are patients for whom opioids may be helpful. "The petition is not saying opioids should never be prescribed beyond 90 days or above 100 milligrams," Kolodny said. "We think there are times when that might be appropriate.
"If a doctor has a patient in front of him and believes for this patient it is appropriate, there is no reason a doctor would not be able to prescribe [opioids] for that patient," he said. "Off label prescribing is often appropriate."
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October 1, 2012
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