Opioid Painkillers Will Have Black Box Warnings in the US

When concerns about opioid addiction and overdose keep mounting, the Food and Drug Administration (FDA) has announced boxed warnings on immediate-release opioid painkillers in the United States.

The Centers for Drug Control and Prevention (CDC) data showed that about 40 Americans die every day due to drug overdose and in 2013, over 1.9 million people abused prescription painkillers.

‘The U.S. Food and Drug Administration has announced class-wide safety labeling changes for immediate-release (IR) opioid pain medications.’

The black box warnings are the strongest indication used for denoting the risks of misuse, abuse, overdose and death. Opioid painkillers are a type of narcotic pain medications used to treat moderate to severe pain. Some of the drugs include morphine, Vicodin and Percocet.

Opioid painkillers are of two types namely extended-release and immediate-release. Extended-release opioids are of higher dosages that are taken once or twice a day. Immediate-release opioids are of lower doses but needs to be frequently administered and, therefore, have an increased risk of misuse, abuse, overdose and death.

"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. 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 FDA Commissioner Robert Califf in a statement.

This effect may help reduce the rising cases of opioid overdose and addiction as these painkillers must only be prescribed if there are no other alternatives. Also, use of immediate-release painkillers during pregnancy can result in neonatal opioid withdrawal syndrome (NOWS).

Source: Medindia