New Warning Labels Coming To Opioid Painkillers

A week after the Centers for Disease Control and Prevention called on physicians to stop prescribing opioid painkillers when less-problematic therapeutic treatments will do the trick, another federal agency is joining in the effort to alert consumers to the potential risks of using these frequently prescribed medications.

The Food and Drug Administration said today that it will require changes to safety labels for all immediate-release opioid pain medications. These are products intended to be taken as frequently as every 4-6 hours, as opposed to extended-release medications that are only meant to be taken once or twice a day. Many of the changes announced today for instant-release drugs were made for extended-release opioids in 2013.

The updated boxed warning — which is exactly what it sounds like: a warning in a box — is intended to bring attention to the serious risks of misuse, abuse, addiction, overdose, and death associated with opioids.

The boxed warning will also require a precaution that chronic maternal use of opioids during pregnancy can result in neonatal opioid withdrawal syndrome for the child, which could be life-threatening if not recognized and treated properly.

The updated indication for these meds will clarify that instant-release opioids should be only be used to treat severe pain that can’t be reduced with the use of non-opioid medications.

Dosing information for instant-release opioids is also being updated to provide clearer instructions regarding patient monitoring and drug administration, including initial dosage, dosage changes during therapy, along with a warning against abruptly halting treatment for patients who have developed a physical dependance on the opioids.

In addition to the changes for labeling of instant-release meds, all prescription opioid products will contain additional safety information about potentially harmful drug interactions with other medicines that can result in a serious central nervous system condition called serotonin syndrome.

This updated labeling will also include information about opioid effects on the endocrine system, including “adrenal insufficiency,” a rare but serious disorder of the adrenal glands and “androgen deficiency” caused by decreased sex hormone levels.

“Opioid addiction and overdose have reached epidemic levels over the past decade, and the FDA remains steadfast in our commitment to do our part to help reverse the devastating impact of the misuse and abuse of prescription opioids,” said FDA Commissioner Robert Califf, M.D.

The FDA also announced today that it is “carefully reviewing” the available scientific information about potentially problematic interactions between opioids and benzodiazepines, a class of drugs that include Valium (diazepam), Klonopin (clonazepam), and many others. If that review confirms that the combined use of these drugs could cause problems, the FDA says it will take actions to ensure prescribers and the public are informed of the risks involved.