The U.S. Food and Drug Administration (FDA) announced Tuesday that safety label changes and post-market study requirements for all extended-release and long-acting (ER/LA) opioid analgesics will be revamped in an effort to combat misuse of, addiction to, and death from the potent drugs. Impacted medications may include morphine, oxycontin, Vicodin, Percocet, and oxycodone.
“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,” said FDA Commissioner Dr. Margaret A. Hamburg.
Opioid analgesics are used for the treatment of moderate to severe chronic pain. They suppress a patient’s perception of pain and helps to calm emotional response by lowering the amount of pain signals sent to the brain. Common side effects of opioid use include constipation, dizziness, drowsiness, and nausea.
Since the drugs are used in the treatment of pain, patients with more severe chronic conditions tend to take them regularly. Physical dependence and addiction have become huge problems among people who use the drugs. The FDA’s new safety labeling and post-market study requirements are intended to help curb those issues.
The class-wide labeling changes will include measures that will help doctors to tailor their prescribing decisions based on each individual patient’s unique needs. The new labeling will also note that the use of ER/LA opioids should be limited to individuals for whom alternative treatments have been ineffective.
“The FDA’s primary tool for informing prescribers about the approved uses of medications is the product labeling,” said Dr. Douglas Throckmorton, deputy director for regulatory programs at 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.”
In addition to label changes, the FDA will also require drug companies to conduct studies and clinical trials on the ER/LA opioids after they enter the market. These post-market studies are intended to assess the risks associated with long-term ER/LA opioid use. Using the data collected by drug companies, the FDA will be able to accurately identify risk factors for abuse and dependence.
“The FDA remains committed to improving the safety of opioids and to continuing to engage in efforts to evaluate and mitigate the risks associated with opioid use,” said Throckmorton. “The FDA will evaluate the results of the post-market studies, continue to monitor relevant safety data, and take further safety action, as warranted.”
For more information on ER/LA opioid analgesics and FDA safety labeling, visit FDA.gov.