(WASHINGTON) — Thirty-seven health care workers signed and submitted a petition to the Food and Drug Administration on Wednesday, urging officials to change labels on prescription opioids, such as OxyContin, morphine or Vicodin — all part of an effort to curb prescription drug abuse.
“If the requested changes were adopted, drug companies would not be able to claim that the pain medications are safe and effective for long-term use by noncancer patients,” read a statement from Public Citizen, the nonprofit advocacy group spearheading the petition.
The petition follows a wave of reports of increased addiction to opioid pain drugs. Although pain management and addiction specialists agreed with the sentiment behind the petition, several doctors told ABC News it takes a step too far by limiting opioid access to noncancer patients with chronic pain.
“I believe this is not an appropriate way to address the disease of addiction,” said Pam Kedziera, the clinical director of Fox Chase Cancer Center’s pain program. “Pain is a significant problem in the United States, and those who suffer deserve treatment.”
The proposal suggests striking the word “moderate” from opioid labels to reserve it only for patients with severe pain; limiting the maximum daily dose to the equivalent of 100 milligrams of morphine; and limiting the maximum prescription duration to 90 days.
Dr. Joshua Prager, who directs the Center for Rehabilitation of Pain Syndromes at the University of California at Los Angeles, told ABC News he’s treated chronic pain patients for nearly 30 years and believes a regulation that would make it harder for doctors to treat these “legitimate patients” would be “extremely regressive.”
Prager’s patients have included people who’ve had a failed back surgery or severe osteoarthritis.
Other chronic pain patients could have shingles, multiple sclerosis or pain from a nerve injury.
“We’ve seen the pendulum go from it being extremely difficult for physicians to prescribe opioids to patients who didn’t have cancer… to where it was clearly being overprescribed,” Prager said. “What I would argue for is that there really has to be balance that doesn’t have the pendulum swing back too fast and too far beyond what is reasonable.”
Prager called the 90-day limit “draconian,” and Kedziera called it “unbelievable.” After all, the definition of chronic is that it is long-lasting, and Kedziera said she’s worried about arbitrarily taking chronic pain patients off medication just because time runs out.
An FDA spokesperson said the agency would respond to Public Citizen. In the meantime, it will allow interested parties to provide input on the issue before it is approved or denied.
Copyright 2012 ABC News Radio
Sonia Moghe and Wayne Drash, CNN
Sam Penrod, KSL.com
Kristina Tieken, FamilyShare