FDA on Tuesday announced that it will require "black box" warnings on certain prescription opioids.
The black box warning is the strongest warning that FDA can issue. The agency says the move will help address growing opioid misuse in the United States.
Read the Q&A: When reducing opioids can make (millions of) dollars and sense
According to CDC, in 2014 almost two million U.S. residents ages 12 and older either misused or were considered to be dependent on prescription opioids. Since 1999, prescription opioids have been linked to about 165,000 overdose deaths.
Warning label details
The black box warning requirement will apply to more than 200 so-called immediate-release opioid painkillers, which account for 90 percent of prescription opioid drugs on the market. Such drugs, which are intended to be used every four to six hours, include hydrocodone, oxycodone, and other commonly prescribed drugs.
Specifically, the requirements will apply to 87 brand-name prescription drugs and 141 generic drugs.
The new labels will include warnings about the risk of addiction, misuse, overdose, and death. In addition, the labels will:
- Emphasize that immediate-release opioids should be a last-resort treatment option for severe pain and should be used only when alternative treatments are not available;
- Warn that chronic use of prescription opioids during pregnancy can result in neonatal opioid withdrawal syndrome, which in some instances can be life-threatening for newborns; and
- Warn users about opioids' potential for harmful interactions with other drugs.
The rules are scheduled to take effect by the end of this year.
Reaction from lawmakers, researchers
Sen. Ed Markey (D-Mass.) in a statement calls the new rules "too little too late." Markey says, "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," adding that past labeling changes "have done little to prevent prescription drug opioid addiction."
According to The Hill, Markey is calling for increased education requirements for physicians who prescribe opioids and for an outside agency to review all opioid prescriptions before they are approved.
Andrew Kolodny, executive director of Physicians for Responsible Opioid Prescribing, criticizes FDA for not requiring labels to include information on the maximum dose or duration of use for the drugs. He says that without those requirements, "the changes will have little impact."
Other stakeholders applaud the changes.
Bruce Psaty, a researcher at the University of Washington who studies drug safety, says FDA "has taken an important step here," adding, "This should help improve prescribing practices in the near term."
Biomedical Regulatory Consulting President Bill Soller also says the new labeling requirements could affect how physicians "prescribe and how they monitor opioid use with their patients," but adds that it will be up to health care providers and consumers to adhere to the warnings (Tavernise, New York Times, 3/22; Grover/Banerjee, Reuters, 3/22; Beilfuss/Burton, Wall Street Journal, 3/22; Bernstein, "To Your Health," Washington Post, 3/22; Ferris, The Hill, 3/22).
Beyond fighting addiction: Reducing opioid prescriptions could cut millions in avoidable costs at your institution
Learn about our analysis of more than 400 organizations to investigate the impact of multi-modal pain regimens, and how your organization may be able to save over $1 million by reducing opioid use during surgery.
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