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FDA Label Changes for Opioid Drugs Designed to Promote Safer Prescribing

The U.S. Food and Drug Administration (FDA) recently ordered label changes for extended-release and long-acting opioid pain relievers. The changes are intended to encourage better prescribing habits by doctors and curb abuse among patients.

Opioids are largely responsible for a surge in prescription drug overdoses in recent years. Drug poisoning is now the leading cause of death from injuries in the United States.

During the most recent decade, the number of drug deaths involving opioid analgesics more than tripled from about 4,000 in 1999 to 14,800 in 2008. To further compound the problem, recent reports also suggest that doctors in California and across the country are increasingly handing out prescriptions for potent opioids like morphine and Oxycodone with little concern for patient safety, often leading to serious addiction problems and death.

The new FDA labeling requirements reflect the risks of both negligent prescribing and patient abuse. They emphasize that other, less potentially addictive, treatment options should be considered first.

New labels must state: “Because of the risks of addiction, abuse and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve [Tradename] for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.”

In addition to the labeling changes, the FDA will also require drug companies to conduct longer-term studies and trials of extended-release and long-acting opioid pain relievers on the market. According to the agency, the companies must “evaluate long-term use, with the goal of assessing a variety of known serious risks, including misuse, abuse, addiction, overdose, and death, as well as the risks of developing increasing sensitivity to pain.”