The US Food and Drug Administration (FDA) has announced it will make changes to safety labeling and post-market study requirements for extended-release and long-acting opioids.
Opioids are a commonly used class of narcotic pain medication. They work by binding to specific proteins called opioid receptors that are located in the brain, spinal cord and gastrointestinal tract. They then block the brain’s ability to perceive pain.
Extended-release and long-acting opioids (ER/LA opioids) are prescribed to patients experiencing moderate to severe persistent pain that needs to be treated over a long period of time.
However, the FDA has long been concerned with the misuse, abuse and overdose risks linked to the drug.
The class-wide labeling changes to be introduced will include “new language” on the labeling in an attempt to assist health care professionals in tailoring their prescribing decisions based on the individual needs of a patient.
The labeling will also emphasize the fact that ER/LA opioids are to be used for the management of pain that is severe enough to need daily, around-the-clock treatment where other treatment options are ineffective.
The FDA says the improved labeling will indicate that due to the risk of addiction, misuse and abuse, as well as the increased risk of overdose, the drugs should be reserved for patients where alternative treatment is strictly ineffective, not just tolerated.
A new caution will also appear on the boxes of ER/LA opioid analgesics, warning that chronic maternal use of these products during pregnancy may result in neonatal opioid withdrawal syndrome (NOWS).
The syndrome can occur in newborns who have been exposed to opioids while in the mother’s womb and can be life-threatening.
Additionally, the FDA says it is issuing notifications to ER/LA opioid application holders specifying the need for changes within various sections of drug labeling. These include:
- Dosage and administration
- Warnings and precautions
- Drug interactions
- Use in specific populations
- Patient counseling information, and
- The Medication Guide.
Douglas Throckmorton, deputy director for regulatory programs at the Center for Drug Evaluation and Research at the FDA, says:
“The FDA’s primary tool for informing prescribers about the approved uses of medications is the product labeling.
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.”
In addition to the labeling changes, the FDA is asking for “post-market requirements,” meaning that drug companies should conduct further studies and clinical trials to determine the risks linked to the long-term use of ER/LA opioids.
They add that through this, the goals are to further assess the already known serious risks, such as misuse, abuse and addiction, increased sensitivity to pain (hyperalgesia), overdose and death.
The FDA says that once these changes are finalized, the ER/LA Opioid Analgesics Risk Evaluation and Mitigation Strategy (REMS) will be updated to reflect the modifications.
Earlier this year, Medical News Today reported that, according to the FDA, increased use of opioids resulted in more than 15,500 deaths in the US in 2009, a 300% increase over the last two decades.