Nearly 40 doctors, researchers, and public health officials Wednesday asked the Food and Drug Administration to change the labeling used on narcotic painkillers, a move that, if approved, would make it more difficult for drug companies to market the medications for chronic, noncancer pain.
Although many of the 37 who signed the petition are associated with the reform group known as Physicians for Responsible Opioid Prescribing, most are from other institutions, including the New York City Health Commissioner, the Cleveland Clinic, the Mayo Clinic, several universities, and the watchdog group, Public Citizen.
The move comes amid concerns that prescribing practices of doctors have contributed to an opioid epidemic in America.
“By implementing the label changes proposed in this petition, FDA has an opportunity to reduce harm caused to chronic pain patients as well as societal harm caused by diversion of prescribed opioids,” the petition says.
Controversy has grown over the practice of prescribing powerful painkillers such as Oxycontin or fentanyl to treat long-term, noncancer pain. Over a decade, prescriptions for opioids have increased four times, accompanied by big increases in opioid-related overdose deaths and in people seeking treatment for addiction.
Before the late 1990s, opioids had been used primarily to treat short-term pain, such as after surgery, and pain associated with cancer and end-of-life disease.
Morgan Liscinsky, an FDA spokesperson, said the agency will review the petition and provide a response directly to Public Citizen.
The issue involves labeling on most opioid analgesics. Public Citizen says most of the labels are overly broad, stating simply that the drugs are approved for moderate to severe pain without any limit on the amount of time a patient should be taking the products.
The petition calls for changing the labels to eliminate the word “moderate,” and to include a maximum of the equivalent of 100 mg a day of morphine and a time period of no more than 90 days when used to treat noncancer pain.
Such uses then would become off-label.
That, in turn, would prevent drug companies from promoting the drugs for the off-label uses such as in advertisements, dinner talks for physicians, and at medical meetings. It also would affect continuing medical education courses.
The changes would not affect a doctor’s ability to prescribe off-label, just such promotion by drug companies, said Sydney Wolfe, MD, director of the health research group at Public Citizen.
The petition notes that many doctors are under the false impression that opioids have been proven safe and effective for long-term noncancer pain.
Typically, studies of opioids for treating noncancer pain last less than 12 weeks.
“In the absence of long-term studies demonstrating safety and effectiveness, we need limits on what drug companies can claim about opioids,” Ed Covington, MD, director of the Neurological Center for Pain at the Cleveland Clinic, said in a statement.
Lewis Nelson, MD, an emergency physician and medical toxicologist at NYU Langone Medical Center, said doctors are wrong in assuming that the current “on-label” use of opioids is based on good scientific evidence.
“It’s time to close the loophole on opioid labels,” he said in a statement.
Both Covington and Nelson signed the petition.
Beginning in the late 1990s, Purdue Pharma and several other companies that market opioids funded activities that promoted use of the drugs for long-term, noncancer pain such as low-back pain and fibromyalgia.
“Over-prescribing of opioids is harming many chronic pain patients,” Covington added. “The label change is a way for the FDA to let the medical community know that risks may outweigh benefits when used long term.”
That is not to say that opioids don’t help some chronic pain patients.
Doctors estimate that about 30% of such patients may benefit. Typically they get about a 30% reduction in pain.
But that uncertainty over who might benefit has to be weighed against serious risks such as addiction, overdosing, respiratory suppression, falls and fractures in the elderly, sleep apnea, and cognitive impairment.
The label change setting the maximum dose at the equivalent of 100 mg of morphine means that it would apply mainly to higher doses of the drugs, which also are the most dangerous, said Andrew Kolodny, MD, president of Physicians for Responsible Opioid Prescribing.
That’s about equal to 14 tablets of Vicodin or 13 tablets of Percocet a day, said Kolodny, chairman of psychiatry at Maimonides Medical Center in Brooklyn. Someone taking twice-a-day, 80 mg of Oxycontin, which is made by Purdue, also would be over that limit, he said.
A Purdue spokesman, noting that opioid use and dosing has been on the FDA’s radar over the past decade, said “FDA, its advisory committees, and numerous medical experts maintain that the current indications for long-acting opioids are appropriate. We agree with the FDA that prescribing information for any medication should be subject to ongoing review and modification to the extent that compelling medical evidence emerges.”
Public Citizen’s Wolfe, said the next step is for the FDA to take action on the petition. He said they could simply grant the labeling changes or hold an advisory panel hearing on the issue.
“They can’t just write this off,” he said.
If the agency does not take action in a reasonable amount of time, Public Citizen could take it to court to force a response, he Wolfe said.
Source: John Fauber, Reporter, Milwaukee Journal Sentinel/MedPage Today-Published: July 25, 2012