FDA to Require Much Stronger Warnings on Opioid Painkillers

The Food and Drug Administration said it will require much stronger warnings on opioid painkillers, making clear they need to be a last-ditch option even for serious pain.

It’s the latest action from federal agencies that are changing the rules in light of a surge in addiction and deaths caused by the drugs, which are cousins of opium and heroin, and under pressure from Congress, which believes the FDA has been too lax in approving new painkillers.

Some members of Congress who have criticized the FDA said the action is "too little, too late". And even the FDA said it was not enough to change much on its own.

“Opioid addiction and overdose have reached epidemic levels over the past decade," said FDA commissioner Dr. Robert Califf.

“Opioid addiction and overdose have reached epidemic levels over the past decade."

“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.”

FDA warns about painkiller use during pregnancy 0:21

The FDA will require makers of the drugs to put a so-called “boxed warning” about the serious risks of misuse, abuse, addiction, overdose and death.

Immediate-relief opioids — those that release the full dose right away — should be reserved for pain severe enough to require opioid treatment that cannot be helped by alternative drugs, the new warnings will say.

“The plan is focused on policies aimed at reversing the epidemic, while still providing patients in pain access to effective relief,” the agency said.

“The FDA is also requiring several additional safety labeling changes across all prescription opioid products to include additional information on the risk of these medications. This is part of the agency’s overall effort to help inform prescribers about the importance of balancing the serious risks of opioids with their role in managing pain.”

Califf admitted that doctors do not always pay close attention to labels. "It's true that most docs don't read labels," he told reporters in a conference call. But Califf said the FDA was limited in what it could do. "The FDA does not regulate the practice of medicine."

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Opioids include morphine, oxycodone, hydrocodone, codeine and other drugs, sold under brand names such as Percocet, OxyContin and Vicodin.

Last week, the Centers for Disease Control and Prevention released guidance for doctors using the drugs to treat chronic pain.

They urged doctors to take it easy in prescribing the potentially killer drugs, emphasizing that overprescribing is helping drive the epidemic of opioid addiction.

The guidelines encourage doctors to try something besides an opioid when first treating pain, even suggesting ice and talk therapy, and to start with low doses.But they also note that some patients really need opioids, including cancer patients, people who are dying and those receiving palliative treatment for incurable pain.

Califf said people can become addicted to the drugs even when they use them as directed.

President Barack Obama has made the overdose epidemic a political priority, asking for $1 billion to address it. And Congress recently held up Califf’s appointment until he promised reforms.

"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."

“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," said Massachusetts senator Ed Markey, a Democrat who's been critical of the FDA.

"Whether it's immediate or extended release, or abuse-deterrent, the labels given by the FDA have done little to prevent opioid addiction. 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."

CDC says deaths from opioid overdoses have hit an all-time record in the U.S.

The drugs killed more than 47,000 people in 2014 — more than the 32,000 who died in road accidents.

"No other medicine routinely given for a non fatal condition kills so frequently," CDC director Dr. Tom Frieden told reporters in a separate conference call Tuesday hosted by the White House. "We have seen a four-fold increase in prescribing associated with a four-fold increase in deaths."

"No other medicine routinely given for a non fatal condition kills so frequently."

The FDA tightened labeling requirements for extended release opioids in 2013. The new labels will also point out the risk to unborn children when pregnant women take the drugs. The babies can be born addicted to the drugs.

The agency is also requiring updated labeling for all to caution about potentially harmful drug interactions including a serious central nervous system condition called serotonin syndrome.

"This is one of dozens of things that need to be done," Califf said.

The White House said it would continue to press states, the industry, regulators and drugmakers to help. "This is an all-of-government approach," said Michael Botticelli, director of National Drug Control Policy.

Botticelli said the administration would press states to require doctors to undergo training in prescribing opioids and to establish programs to monitor drug prescribing in real time so that problem doctors and problem patients can be flagged.