FDA Wants Black-Box Warnings On Immediate-Release Opioids

The Food and Drug Administration yesterday announced new labeling requirements for immediate-release (IR) opioid pain medications including a boxed warning about “the serious risks of misuse, abuse, addiction, overdose and death.”

“Black-box warnings are the most stringent the agency can require, and they have been found to get doctors' attention and influence their prescribing decisions,” writes Rob Stein for NPR.org.

On a conference call with reporters following the announcement, however, FDA commissioner Robert Califf “admitted that doctors do not always pay close attention to labels,” reports Maggie Fox for NBCNews.com. But Califf said the FDA was limited in what it could do. ‘The FDA does not regulate the practice of medicine.’”



The new requirements are for “fast-acting versions of opioids, such as oxycodone, hydrocodone and morphine, which are intended for use every four to six hours for serious acute pain. Ninety percent of all opioid prescriptions are for these fast-acting, or immediate-release, formulations,” NPR’s Stein reports. 

Specifically, the requirements affect 87 brand-name drugs and 141 generics, Sabrina Tavernese reports for the New York Times. Similar 2013 requirements for extended-release opioids, “which are often seen as a bigger addiction risk because of their potency,” affected 34 products. 

“Here's how the warning will play out for consumers,” writes CNN’s Nadia Kounang. “When a patient gets his or her prescription filled, the bottle should have a notification indicating there is a black-box warning for the drug. The consumer would need to go to the manufacturer's website for details.

“In addition, pharmacists are encouraged to provide patients with a medication guide — consumer-friendly language explaining the risks of the drug,” Kounang continues. 

“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,” Califf says in a release about the new requirements. 

Yesterday’s announcement comes as pressures have mounted in Washington for officials to take action on what increasingly is being spotlighted as a public health crisis after being in the shadows for years.

“‘No other medicine routinely given for a non-fatal condition kills so frequently,’ [Centers for Disease Control] 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,’” NBC’s Fox reports.

And increasingly, people who develop a dependence on prescription medications, whether taken on doctor’s orders or obtained illicitly, turn to cheaper street heroin to forestall painful withdrawal symptoms. 

“Heroin-related deaths jumped 39% from 2012 to 2013, and the longer-term trends are equally disturbing: from 2002 to 2013, the rate of heroin-related overdose deaths nearly quadrupled, according to the Centers for Disease Control and Prevention,” Katharine Q. Seelye reported for the New York Times in a “guide to the drug's spread and impact” last October.

Many say the FDA needs to do more, and it “has been criticized as too willing to approve the painkillers and too slow to fight their abuse,” Lenny Bernstein reports for the Washington Post. Last month Califf himself called for a “sweeping review” of its policies.

In February, 41 officials from various state and municipal health departments, as well as some academics, presented a petition to the FDA urging they issue black-box warnings about the potential dangers of taking opioid painkillers with benzodiazepines — anti-anxiety drugs such as Valium and Xanax, as Brady Dennis reported for the Washington Post

Doctors will “prescribe opioids to a patient with acute pain, along with a benzodiazepine to treat muscle spasms. Or benzodiazepines for a patient with an anxiety disorder, along with an opioid to treat chronic pain,” Brady writes. Taken together, they can depress the respiratory system and result in death.

A year-old opioid initiative within the Department of Health and Human Services is focusing on three priority areas: informing opioid prescribing practices, increasing the use of naloxone (a rescue medication that can prevent death from overdose) and expanding access to and the use of Medication-Assisted Treatment (MAT) to treat opioid use disorder.

Some localities are taking bolder measures to prevent deaths. Ithaca, N.Y., yesterday issued a 64-page plan to combat the city’s heroin addiction that includes a provision for a “supervised injection facility,” reports Julianne Peixoto for WBNG.com.

“A lot of folks have been looking for and waiting for ideas to actually help to solve this epidemic instead of just arresting people, forcing them into treatment and then watching them fail again and again,” says Ithaca’s mayor, Svante Myrick.

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