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FDA Orders Warning Labels on Prescription Narcotic Painkillers

Immediate-release versions of addictive meds such as Oxycontin, Percocet and Vicodin to be affected

By E.J. Mundell and Steven Reinberg
HealthDay Reporters

TUESDAY, March 22, 2016 (HealthDay News) -- Hoping to curb a national epidemic of prescription painkiller abuse, U.S. officials on Tuesday announced that certain drugs will get new "boxed warnings" about the dangers of misuse.

The move by the U.S. Food and Drug Administration comes one week after the U.S. Centers for Disease Control and Prevention announced tough new guidelines to doctors for "opioid" drugs such as Oxycontin, Percocet and Vicodin.

"We are at a time when the unfathomable tragedies resulting from addiction, overdose and death has become one of the most urgent, devastating public health crises facing our country," FDA Commissioner Dr. Robert Califf told reporters at a Tuesday news briefing.

He said the agency is working with other agencies, drug makers, doctors and patients "to prevent abuse, save lives and treat dependence while still providing patients in pain access to effective relief."

The new labeling rules are mostly aimed at highly addictive "immediate-release" versions of narcotic painkillers. According to an FDA news release, the new label requirements include:

  • A new boxed warning on the "serious risks of misuse, abuse, addiction, overdose and death."
  • A new prescribing guideline that immediate-release opioids "should be reserved for pain severe enough to require opioid treatment and for which alternative treatment options are inadequate or not tolerated."
  • Labeling stressing the risk of "neonatal opioid withdrawal syndrome" in babies born to mothers who took opioid painkillers during their pregnancy.

Besides this new labeling for immediate-release narcotic painkillers, the FDA is also mandating other revised labeling for all opioids -- even extended-release versions.

All of these drugs will now include information on labels warning of potential harmful interactions of the drug with other medicines "that can result in a serious central nervous system condition called serotonin syndrome," the agency said.

Labels will also warn of possible glandular or hormonal changes linked to opioid use.

The new rules come after CDC action on prescription painkillers, announced March 15. The CDC advisory stressed that doctors -- especially primary care physicians -- should try to avoid addictive "opioid" painkillers whenever possible for patients with most forms of chronic pain.

For example, this would include patients suffering from joint or back pain, dental pain (tooth extraction, for example), or other chronic pain treated in an outpatient setting.

It would not include the use of narcotic painkillers for people dealing with cancer-related pain, or terminally ill patients in palliative care, the CDC said.

"More than 40 Americans die each and every day from prescription opioid overdoses," CDC Director Dr. Tom Frieden said during a news conference last Tuesday. "Increased prescribing of opioids -- which has quadrupled since 1999 -- is fueling an epidemic that is blurring the lines between prescription opioids and illicit opioids," he added.

Recent reports have sounded alarm bells about the mounting death toll from narcotic painkiller abuse.

In December, the CDC announced that fatal drug overdoses had reached record highs in the United States -- driven largely by the abuse of prescription painkillers and another opioid, heroin. Many abusers use both.

According to the December report, more than 47,000 Americans lost their lives to drug overdose in 2014, a 14 percent jump from the previous year.

Reacting to the crisis last October, President Barack Obama noted that the daily death toll from drug overdoses now exceeds that of car crashes. At the time, the White House announced a major initiative aimed at combating the trend. The CDC advisory released Tuesday is a part of that effort.

Besides calling for physicians to prescribe non-narcotic options first for pain relief, the CDC advisory also laid out other steps to curb the abuse of opioid painkillers.

Whenever these painkillers are prescribed, "the lowest possible effective dosage" should be used, the CDC said.

Also, patients who are on such drugs should be closely monitored to "reassess [patient] progress and discontinue medication if needed," the agency said.

The CDC said it was aiming the new guidelines at primary care physicians, because those doctors currently write nearly half of all prescriptions for narcotic painkillers.

Speaking last week, one expert applauded any effort to tighten control on prescription painkillers.

"These guidelines raise awareness of the hazards of unscrupulous opioid prescribing, as well as highlight the value of non-opioid medications and non-pharmacologic therapies," said Dr. Harshal Kirane, who directs addiction services at Staten Island University Hospital in New York City.

"The opioid abuse epidemic can impact any of us, so it requires all of us to bring about sustainable change," he said.

More information

There's more on the epidemic of prescription painkiller abuse at the U.S. National Institutes of Health.

SOURCES: March 22, 2016, news conference with Robert Califf, M.D., commissioner, U.S. Food and Drug Administration, and Doug Throckmorton, M.D., deputy center director, regulatory programs, FDA's Center for Drug Evaluation and Research; March 15, 2016, news conference with Tom Frieden, M.D., director, U.S. Centers for Disease Control and Prevention; March 21, 2016, news release, U.S. Food and Drug Administration; March 15, 2016, news release, U.S. Centers for Disease Control and Prevention; Harshal Kirane, M.D., director, addiction services, Staten Island University Hospital, New York City

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