Last week on Tuesday the FDA announced changes to their labeling requirements for long-acting painkillers, in an effort to curb prescription drug abuse. Agency officials said the labeling changes, which will take effect by the end of the year would “help improve the thoughtful prescribing of these medicines,”. OxyContin, Morphine, Opana, Fentanyl and other medications are affected by these changes.
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 A. Hamburg, M.D. “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.”
The new steps come against the backdrop of opioid abuse and misuse that has been termed “epidemic” by the Centers for Disease Control and Prevention. In 2010, more than 12 million Americans reported they had taken opioid narcotics for purposes other than those approved by the FDA.
At the heart of the changes is a modification of the language on what kind of pain the drugs are supposed to be prescribed for. Current labels say the drugs should be used for moderate to severe pain. The updated labels will state that “ER/LA opioids are indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Because of the risks of addiction, abuse, and misuse, even at recommended doses, and because of the greater risks of overdose and death, these drugs should be reserved for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain; ER/LA opioid analgesics are not indicated for as-needed pain relief.”
The new language basically states that instead of the loosely defined moderate to severe pain, these drugs should only be prescribed to patients that need 24/7 pain relief and have tried alternative treatments which have failed. Also the labeling warns about the risk of addiction and abuse.
The move was prompted by a petition from Physicians for Responsible Opioid Prescribing, an advocacy group in New York. Dr. Andrew Kolodny, the president of the group, said that he was pleased by the announcement, but that he would have liked the agency to have gone further, for example by defining limits on the duration of use and dosage.
The FDA is also requiring producers of such drugs to conduct studies on the long-term risks of taking them. Researchers praised the move, a major issue hanging over opioid use is a lack of data about the drugs’ long-term risks and effectiveness. Douglas Throckmorton, M.D., deputy director for regulatory programs in the FDA’s Center for Drug Evaluation and Research said the agency was trying to address that by telling producers that they had to run studies and clinical trials on drugs currently on the market to better assess the risks. The goals of these postmarket requirements are to further assess the known serious risks of misuse, abuse, increased sensitivity to pain (hyperalgesia), addiction, overdose, and death.
The next step, Dr. Throckmorton said, is “a series of conversations” with manufacturers of such drugs “about what those studies and trials will look like.” He expects to start receiving information in 2015. Dr. Erin E. Krebs, a pain researcher at a Department of Veterans Affairs facility in Minneapolis, said that “it would be fabulous” to have such data so that doctors could better understand how or whether they should be prescribing opioids for long periods. Dr. Nathaniel Katz, an assistant professor of anesthesia at Tufts University School of Medicine in Boston, said he was skeptical that the labeling changes would have much of an effect, because they represented current practice. But he said the requirement that companies conduct studies was a major advance. “We can’t possibly prescribe these drugs knowledgeably unless we know what the incidence is of serious and fatal complications,” he said.
Officials said they have seen a sharp increase as well in the numbers of babies born in the United States who have been exposed to opioid painkillers in utero — a condition that can result in painful and potentially life-threatening withdrawal symptoms in the early days of life. The changes ordered by the FDA also encourage physicians to discuss the potential dangers of opioid medications to an unborn child when dealing with women of childbearing age.
The FDA is also requiring a new boxed warning on ER/LA opioid analgesics to caution that chronic maternal use of these products during pregnancy can result in neonatal opioid withdrawal syndrome (NOWS), which may be life-threatening and require management according to protocols developed by neonatology experts. NOWS can occur in a newborn exposed to opioid drugs while in the mother’s womb. Symptoms may include poor feeding, rapid breathing, trembling, and excessive or high-pitched crying.
“The FDA remains committed to improving the safety of opioids and to continuing to engage in efforts to evaluate and mitigate the risks associated with opioid use,” said Dr. Throckmorton. “Today’s safety labeling changes reflect the FDA’s current understanding of the risks and benefits of these products. The FDA will evaluate the results of the postmarket studies, continue to monitor relevant safety data, and take further safety action, as warranted.”
While these changes are a good step in the right direction, its a drop in the ocean of what needs to be done to combat the epidemic of prescription drug abuse in this country. I feel the labeling is sound in that it explicitly states the originally intended use of these long acting painkillers, its not enough though. Any doctor that isn’t aware of the prescription drug abuse problem in this country has either been living under a rock, or is blissfully ignorant. So in a perfect world the labeling shouldn’t affect a doctor if they are prescribing the medication ethically or not. Any person who is abusing the medication won’t care what the labeling says, I know I didn’t. However it may help the decision making of a patient uninformed of the risks.
The question that also arises is that will this make those that legitimately need medication that much harder to get? Will every doctor now think a little too carefully if they should prescribe a long acting narcotic painkiller to a patient who legitimately needs it? At the very least having more long term research on these medications is great. The problem that could arise is that because the onus is on the drug companies to fund and research these studies, it would be favorable for results to skew in favor of the medication. How neutral will these studies be?
What do you think, is this a step in the right direction or just business as usual? Let me know.
C.S. Bridger is an LA based writer and photographer trying to make sense of recovery