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FDA extends warning label mandate to all opioids. Will it help?

The Food and Drug Administration will be requiring new labels to be printed on opioid painkillers in an effort to educate and warn users of the potential risks of the medication.

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OxyContin pills arranged for a photo at a pharmacy in Montpelier, Vt. OxyContin is a long-acting opioid painkiller that received federal guidance in 2013 to print similar warnings on its labels to those announced for immediate-release painkillers on Tuesday.

Toby Talbot/AP/File

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The federal government announced Tuesday a new measure designed to educate recipients of painkiller prescriptions about the link between pain medication and the scourge of opioid abuse that has claimed tens of thousands of American lives in recent years.

The Food and Drug Administration (FDA) will now require drug manufactures to include a printed warning on all immediate-release (IR) opioid pain medications that informs patients of the potential for "misuse, abuse, addiction, overdose, and death" related to the medication.

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“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,” said FDA Commissioner Robert Califf in an agency release. “Today’s actions are one of the largest undertakings for informing prescribers [and patients] 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.”

The FDA announcement of the new boxed warnings comes one week after the Centers for Disease Control and Prevention issued new guidelines regarding opioid prescriptions for doctors. That update suggests that doctors place more emphasis on screenings to determine if opioids are the right treatment option for their patients, and that physicians prescribe fewer days’ worth of painkillers at a time.

There is some evidence to suggest that warning labels do influence doctors' decisions about prescriptions. 

The FDA hopes that the new warnings will also better educate patients seeking pain relief from IR opioid medication. The administration says that IR opioids should only be used to relieve pain in situations when alternative treatment options are exhausted due to the drugs’ risks.

“We're at a time when the unfathomable tragedies resulting from addiction, overdose and death have become one of the most urgent and devastating public health crises facing our country,” Mr. Califf said, the Associated Press reports. “I can't stress enough how critical it is for prescribers to have the most current information.”

The new FDA regulation comes three years after the agency implemented a similar requirement for all extended-release (ER) and long-acting (LA) opioid pain relievers. Despite that initiative and Tuesday’s announcement, though, some say the administration is not acting quickly enough to fight the wave of opioid abuse and fatalities.

“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,” Massachusetts Sen. Edward Markey (D) told AP.

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The FDA will also add warnings about the potential effects of maternal use of opioids on unborn children. Additionally, both IR and ER/LA drugs will now carry warnings about adverse drug interactions with other medications.

“I think we're very heartened by the new director of the FDA and his enhanced focus on opioid issues,” said Michael Botticelli, director of the Office of National Drug Control Policy, per the AP. “This is an all-of-government effort and clearly the FDA has a key role to play.”

This report includes material from the Associated Press.


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