FDA will require warnings on immediate-release painkillers

In an effort to stem the epidemic of prescription drug abuse, the Food and Drug Administration will require its strongest warning on immediate-release opioid painkillers.

The "black box" warning will alert users to the "serious risks of misuse, abuse, addiction, overdose and death" involved with taking opioids, a class of painkillers that includes morphine, Vicodin and Percocet. The warnings will appear on immediate-release painkillers, which are taken every four to six hours.

The FDA issued warnings on extended-released painkillers, which contain higher doses and are taken once or twice a day, in 2013. Extended-release opioids pose special risks, because people can crush them to produce a strong high, making them a target for abuse.

"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 in a statement. "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.”

About 40 Americans die each day from overdosing on prescription painkillers, according to the Centers for Disease Control and Prevention. In 2013, an estimated 1.9 million people abused or were dependent on prescription opiates.

The labels for immediate-release opioids will now say that they should only be prescribed when there are no alternative treatments. Drug labels will also note that taking opioids repeatedly while pregnant can cause neonatal opioid withdrawal syndrome, a potentially life-threatening condition in babies. 

The FDA's announcement comes at a time of mounting concern over opioid addiction and overdoses.

Last week, the CDC released opioid prescribing guidelines for the first time. The guidelines urge doctors to avoid prescribing opioids for chronic pain unrelated to cancer or end-of-life care, noting that the drugs have serious risks but few demonstrated benefits.

Also last week, Massachusetts' governor signed the first law in the nation to limit a person's first opioid prescription to seven days. The law also provides education for students and doctors.

The FDA has been criticized for not doing enough to stem the opioid addiction crisis, particularly by Sen. Edward Markey, D-Mass., who tried to hold up Califf's approval as a way to pressure the FDA to do more to fight addiction.

“Today’s announced changes to the labels of opioid products will finally reflect what we have known about these drugs for decades — they are dangerous and addictive and can lead to dependency, overdose and death," Markey said in a statement. "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."

Markey said the FDA needs to do more to protect patients. All new opioids should be reviewed by an advisory committee of outside experts, for example. Doctors also need more education about how to prescribe pain relief safely, he said.