The U.S. Food and Drug Administration has announced a class wide safety labeling change and new postmarket study requirement for all extended release and long acting opioid analgesics intended for the treatment of pain.

“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.”

Serious risk comes with using extended release and long acting opioids. Class wide labeling changes would include new language that would help health care professionals better tailor prescriptions based on each patient’s unique needs.

The updated labeling will  indicate that these types of opioids are intended for the management of pain that is severe enough to require daily, around the clock, long term treatment and in cases where alternative treatments are inadequate for pain management.

The updated labeling will also clarify the risks of addiction, abuse and misuse, even at the recommended doses. Due to the greater risk of overdose and death, labeling will reflect the recommendation that the drugs should be reserved for use in patients where alternative treatment options are ineffective, not tolerated or would otherwise provide inadequate pain management. Extended release and long acting opioids are not intended 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 has recognized that more information is needed to assess the serious risks associated with long term use of these drugs, so they are requiring drug companies manufacturing these products to conduct further studies and clinical trials. The goal of these new postmarket requirements is to further assess the known serious risks of misuse, abuse, increased sensitivity to pain, addiction, overdose and death.

They are also requiring a new boxed warning on the drugs to caution against chronic maternal use during pregnancy because it could result in neonatal opioid withdrawl syndrome (NOWS), which can be life threatening. NOWS can occur in newborns exposed to opioids while in their mother’s womb. Symptoms consist of poor feeding, rapid breathing, trembling and excessive or high pitched crying.