Controversy abounds when prescription medication is the topic. In mid-April, the U.S. Food and Drug Administration (FDA) gave notice that it was updating the label for a hydrochloride medication, commonly known as OxyContin. In an explicit warning, the new packaging will alert users to the new properties of the drug in hopes of preventing abuse.
Citing prescription overdose as a public health epidemic, Douglas Throckmorton, MD, deputy director for regulatory programs at the FDA’s Center for Drug Evaluation and Research, said, “The development of abuse-deterrent opioid analgesics is a public health priority for the FDA,” and although “both original and reformulated OxyContin are subject to abuse and misuse, the FDA has determined that reformulated OxyContin can be expected to make abuse by injection difficult and expected to reduce abuse by snorting compared to original OxyContin.”
Some of the issues relating to prescription medication abuse caused the FDA to release the following analysis.
- Citizen petitions requesting that the agency determine whether original OxyContin was voluntarily withdrawn from sale for reasons other than safety or effectiveness
- Information concerning original and reformulated OxyContin and the withdrawal of original OxyContin
- Clinical data, peer-reviewed literature, and other information concerning postmarketing adverse events associated with original OxyContin, reformulated OxyContin, and other extended-release oxycodone products
- Postmarketing assessments of the impact of reformulated OxyContin on abuse are ongoing, and the FDA will update its evaluation of the effects of reformulated OxyContin on abuse as new data become available.
Ultimately, the FDA said, its goal is to both “encourage the development of abuse-deterrent formulations of opioids” and to “help reduce prescription drug abuse.” The Agency was firm in its commitment to providing patients with pain relieving medications that are appropriate and safe. Find out more about this labeling notification.