FDA adds new warnings on risk of addiction, overdose and death for some prescription opioids

A kit of Naloxone, which can reverse the effects of an opioid overdose. (Andrew Burton/Getty Images)

The Food and Drug Administration announced Tuesday morning that it would require new warnings about the risk of addiction, abuse, overdose and death for short-acting opioid pain medications, a step toward curbing the epidemic of narcotic use in the United States.

The "black box" warnings for immediate-release medications — powerful narcotics intended for use every four to six hours — also will warn of the danger that chronic use of the drugs by pregnant women can result in newborns who must go through the painful process of withdrawal, known as Neonatal Opioid Withdrawal Syndrome.

One study shows that 14 percent of pregnant women have been prescribed the powerful opioid medications for pain.

[CDC warns doctors about the dangers of prescribing opioid painkillers]

The new FDA warnings will emphasize that immediate-release opioids should be a last resort for severe pain when other painkillers don't work or can't be tolerated by patients. Dosing information will provide clearer instructions to prescribers about how to administer the drugs and monitor patients, along with a warning not to "abruptly stop treatment in a physically dependent patient," according to an FDA news release.

It will apply to more than 200 short-acting opioid products, an FDA spokeswoman said, including widely prescribed medications, such as OxyContin, Vicodin and others. Those immediate release opioids represent about 90 percent of the products on the market. Similar warnings were added to packaging for extended release medications in 2013, said Douglas Throckmorton, deputy director of regulatory programs for the FDA's Center for Drug Evaluation and Research.

The FDA made its announcement even as a congressional oversight committee was probing the causes and effects of the nation's opioid epidemic. Deaths from opioid overdoses — both prescription narcotics and street drugs, such as heroin — killed a record 28,647 people in 2014, according to the Centers for Disease Control and Prevention.

[One county, 69 minutes, eight overdoses]

Last week, the CDC issued the first national guidelines for doctors on the use of opioids. They urge physicians to use more caution and to consider alternatives before they prescribe highly addictive narcotic painkillers.

The FDA is briefing the news media on the warnings at 1:30 p.m., and we'll update this post after that.

Source by : https://www.washingtonpost.com/news/to-your-health/wp/2016/03/22/fda-adds-new-warnings-on-risk-of-addiction-overdose-and-death-for-some-prescription-opioids/