FDA Restricts Long-term Opioid Use in Order to Combat Addiction

The U.S. Food and Drug Administration has ordered a class-wide label change for long-acting opioids, including OxyContin (oxycodone) and other prescriptions aimed at helping reverse severe pain.

This was announced Tuesday at a press briefing along with several other changes regarding a curb for the ongoing prescription painkiller epidemic, such as a label clarification about the risk of abuse and deaths with the drugs, a requirement for additional postmarketing studies and a boxed warning regarding the risks of neonatal opioid withdrawal syndrome, according to the FDA's website. 

"Opioids are important pain relieving medications that provide significant benefits when used appropriately," Douglas Throckmorton, MD, deputy director of the FDA's Center for Drug Evaluation and Research (CDER), said during a press briefing, according to USA Today. "But they have significant risks associated with inappropriate patient selection and improper use, whether accidental or intentional."

This announcement is based on a series of meetings regarding drug safety presented largely by the Citizen's Petition from the group Physicians for Responsible Opioid Prescribing (PROP) and Public Citizen, which had nearly 40 doctors, public health officials and researchers sign in order to make it more difficult for drug companies to market these prescriptions for chronic pain.

"The change reflects a departure from an indication that was based on a severity scale and transitions to a more specific use," Throckmorton said, via USA Today. "Patients in pain will not only be assessed by a rating on a pain scale, but a more thoughtful determination of pain."

The FDA also requires postmarketing studies in order to further assess pain risks.

Psychology Today notes that narcotics mimic the pain-relieving chemicals that the body naturally produces. Prescribing the correct amount of products can be essential to pain management, which can be a particularly delicate process. Prescribing too much for longer periods of time can result in addiction.