FDA to require new boxed warnings on opioids


141 generic and 87 branded immediate-release opioid pain medications will be affected.

A month after FDA announced several measures aimed at curbing opioid abuse, the agency said it would require new boxed warnings addressing the serious risk of misuse, abuse, addiction, overdose, and death on 141 generic and 87 branded immediate-release (IR) opioid pain medications (about 90% of all Rx opioids).

FDA is also requiring several additional safety labeling changes across all prescription opioid products.

See also: One-quarter of patients prescribed opioids progress to long-term use

Sweeping changes

The sweeping actions, announced March 22, modify the approved indications for use of medications and in many cases add boxed warnings.

“Until this action, very few IR products had boxed warnings,” said Doug Throckmorton, MD, deputy center director, regulatory programs, Center for Drug Evaluation and Research, on a phone call with reporters.

Boxed warnings will state that addiction can occur even when opioids are used appropriately, Thockmorton said.

“Today’s actions are one of the largest undertakings for informing prescribers of risks across opioid products, and one of many steps the FDA intends to take this year as part of our comprehensive action plan to reverse this epidemic,” said Robert Califf, MD, the new FDA commissioner.

Appropriate access

The updated boxed warning states that, because of the associated risks, IR opioids should be reserved for pain severe enough to require opioid treatment and for which alternative treatment options (such as non-opioid analgesics or opioid combination products, as appropriate) are inadequate or not tolerated.

The new dosing information provides clearer instructions pertaining to initial drug dosage, dosage changes during therapy, and a warning not to stop treatment abruptly if a patient is  physically dependent.

“FDA is committed to working with the healthcare community to help avoid opioid abuse and misuse, while assuring that patients have appropriate access to pain medications,” Thockmorton said.

Revised boxed warnings also caution that chronic maternal use of opioids during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening.

In addition, FDA is requiring updated labeling for all opioids (both ER/LA and IR products) to include safety information about potentially harmful drug interactions with other medicines that can result in a serious central nervous system condition known as serotonin syndrome.  

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