FDA Requires Immediate-release Opioids To Sport New Boxed Warning

The agency has added the new policy to all immediate-release opioids, including Percocet (acetaminophen/oxycodone).

The Food and Drug Administration announced Tuesday plans to add a boxed warning - the most serious type - to all immediate-release opioid painkillers, which include roughly 175 branded and generic drugs.

The medications now have a black box warning-the most serious of FDA's cautions.

Robert Califf, FDA commissioner, said, "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".

The new labels update information about dosage for the patient including the size of the initial dose, how to monitor patients using opioids and a warning not to abruptly stop treatment for a physically dependent patient. Those are given for pain severe enough to require daily, round-the-clock treatment and contain more drug per tablet than immediate-release tablets.

The FDA is also requiring several additional safety labeling changes across all prescription opioid products to include addition information about the risk the medications pose.

The announcement comes on the heels of efforts from other federal agencies to educate prescribers and patients about the potential risks related to opioid use.

Deaths linked to misuse and abuse of prescription opioids climbed to 19,000 in 2014, the highest figure on record, according to the Centers for Disease Control and Prevention.

The FDA wants to warn doctors and patients about the dangers of the drugs while ensuring they remain available for patients who need them to alleviate pain.

"We know that there is persistent abuse, addiction, overdose mortality and risk of NOWS associated with IR opioid products", said Douglas Throckmorton, M. D., deputy center director of regulatory programs, FDA's Center for Drug Evaluation and Research. "Unfortunately, it has taken FDA far too long to address the grave risks of these drugs that have claimed the lives of thousands this year alone".

The move is one of a series announced recently by the FDA as it seeks to tackle the problem of opioid overdose and death.

A year-old opioid initiative within the Department of Health and Human Services is focusing on three priority areas: informing opioid prescribing practices, increasing the use of naloxone (a rescue medication that can prevent death from overdose) and expanding access to and the use of Medication-Assisted Treatment (MAT) to treat opioid use disorder.

"The main driver of our opioid epidemic is addiction, and the immediate-release products are just as addictive... that's why they should be prescribed more cautiously", said the group's founder, Dr. Andrew Kolodny, an addiction therapist.

Source: FDA Requires Immediate-release Opioids To Sport New Boxed Warning