The U.S. Food and Drug Administration (FDA) jut announced safety labeling changes and post-market study mandates on opioid analgesics. According to the agency, the new boxed warnings will include information on neonatal opioid withdrawal syndrome.
The labeling change involves the entire class of medications and the post-market study requirements include extended-release (ER) and long-acting (LA) opioid pain medications. “The FDA is invoking its authority to require safety labeling changes and post-market 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,” FDA Commissioner Margaret A. Hamburg, M.D. said. “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.”
Once the class-wide labeling changes are fully in place, the new language will better enable health care professionals to individualize prescribing choices based on individual patient needs.
The updated labeling states that ER/LA opioids are indicated for the management of pain that is severe enough to mandate daily, around-the-clock, long-term opioid treatment and for which other treatment options are not sufficient. The updated indication also clarifies that, because of addiction, abuse, and misuse risks, even at recommended doses, and because of increased overdose and death risks, these drugs should only be used in situations in which other options—non-opioid analgesics or immediate-release opioids—are not effective or tolerated or which would be insufficient to provide appropriate pain management. ER/LA opioid analgesics are not indicated for as-needed pain relief.
“The FDA’s primary tool for informing prescribers about the approved uses of medications is the product labeling,” said Douglas Throckmorton, M.D., deputy director for regulatory programs in the FDA’s Center for Drug Evaluation and Research. “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.”
The FDA is also mandating ER/LA opioid drug makers to conduct additional studies and clinical trials to assess serious risks tied to long-term use of these drugs so that a further assessment of known serious risks of misuse, abuse, hyperalgesia (increased sensitivity to pain), addiction, overdose, and death can be made.
The FDA is also requiring the new warning to caution that chronic maternal use of these drugs during pregnancy may result in neonatal opioid withdrawal syndrome (NOWS), which may be life-threatening and may require management according to protocols developed by neonatology experts. NOWS may occur in newborn babies exposed to opioid drugs during pregnancy and may include poor feeding, rapid breathing, trembling, and excessive or high-pitched crying.
Agency officials stated that the labeling changes are scheduled to take effect by year-end, according to the New York Times. Opioids include drugs such as the very addictive OxyContin, morphine, and fentanyl. Today’s labeling states that the drugs should be used for moderate to severe pain, which Dr. Throckmorton said is not appropriate. “What is moderate to me could be severe to you,” he said, according to the Times.
Although opioids were originally prescribed to patients in acute pain, such as what is seen in cancer patients, in the past 10 years, opioid use has expanded to more moderate pains, including arthritis and back pain, according to The Washington Post. The increased use has led to increased issues with addition and the drugs’ illicit use. In fact, a 2009 National Survey on Drug Use and Health revealed that 2 million Americans were addicted to or abusing prescription pain relievers, much higher than for cocaine or heroin addictions.
A 2013 Centers for Disease Control and Prevention (CDC) report indicated that while overdose deaths consistently increased from 1999 to 2010, deaths tied to opioids increased five-fold in women and 3.6 times in men during the same period, according to the Washington Post.