Drug regulators are issuing new rules designed to combat prescription drug abuse and addiction.
The new label standards announced by the Food and Drug Administration (FDA) on Tuesday will tell doctors not to prescribe painkillers like morphine and oxycodone that can be easily misused unless all other options have been exhausted.
The drugs, technically known as long-acting and extended release opioids, are sometimes abused or taken recreationally. That can lead to overdose and death, the FDA warned.
“Today’s action demonstrates the FDA’s resolve to reduce the serious risks of long-acting and extended release opioids while still seeking to preserve appropriate access for those patients who rely on these medications to manage their pain,” FDA Commissioner Margaret Hamburg said in a statement.
The labels will include new language clarifying that the drugs are only to be used for people with pain severe enough to require “daily, around-the-clock, long-term” treatment, according to the FDA.
Drugs will also include a boxed warning for pregnant mothers. Children in their mothers’ womb can be affected by chronic use of the drugs, and as newborns they can display withdrawal symptoms that could result in death.
“The goal of all of these labeling changes is to help physicians work with their patients to determine whether these potent pain relievers are the most appropriate treatment for their specific situation and if so, to help them in managing their use,” Hamburg added in a blog post on the FDA’s website.
According to the Centers for Disease Control, more than 15,000 Americans died in 2009 from opiod pain relievers like oxycodone.
“The FDA’s primary tool for informing prescribers about the approved uses of medications is the product labeling,” added a statement from Douglas Throckmorton, the agency’s deputy director for regulatory programs.
He said that the changes “will encourage better, more appropriate, prescribing, monitoring and patient counseling practices involving these drugs.”
— This post was updated with additional information at 3:13 p.m.