FDA Announces Label Changes to Improve Opioid Safety

Labels on all extended-release and long-acting opioid analgesics will be amended to ensure they are used only by those who need them and to warn pregnant women of the risk of neonatal narcotic withdrawal syndrome.

In an effort to combat the rising rate of opioid-related deaths, the FDA will require safety label changes on all extended-release and long-acting opioid analgesics, the agency announced on September 10, 2013.

The new safety information will emphasize that the drugs are only to be used for patients requiring continuous treatment when other treatment options, including non-opioid analgesics or immediate-release opioids, are ineffective or intolerable. The labels will also indicate that the drugs should not be used on an “as-needed” pain relief basis. The new labels aim to reduce serious risks associated with opioid painkillers, including addiction and death, and to help health care professionals better assess patient needs when prescribing painkillers.

“The FDA’s primary tool for informing prescribers about the approved uses of medications is the product labeling,” said Douglas Throckmorton, MD, deputy director for regulatory programs in the FDA’s Center for Drug Evaluation and Research, in a press release. “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.”

Although current labels already include information on the effects of the drugs on newborns, the new labels will include updated warnings against use of these drugs by pregnant women. The information will be displayed in a boxed warning, the most prominent labeling position, and will include more details on the risk of neonatal opioid withdrawal syndrome in children born to women who use the medications while pregnant.

In addition to label changes, opioid manufactures will also be required to update educational materials for health care professionals and patients, including paper handouts given to patients with a prescription. After label changes are finalized, the extended-release and long-acting Opioid Analgesics Risk Evaluation and Mitigation Strategy will also be updated to remain consistent with the new information.

In order to foster better understanding of the potential risks and benefits of the drugs, the FDA will also require drug companies to conduct longer studies and trials of extended-release and long-acting opioid painkillers that are already on the market. The studies will assess known risks associated with the drugs, including increased sensitivity to pain, misuse, abuse, addiction, overdose, and death.

Through these combined strategies, the FDA hopes to increase the safety and reduce the risks of using opioid pain relievers.

“This is not the first or last initiative, and we will continue supporting broader efforts to solve the serious public health problems associated with the misuse and abuse of opioids,” Throckmorton said.