FDA orders starker warnings on opioid painkillers

WASHINGTON — The Food and Drug Administration is requiring stronger warning labels on prescription painkillers like OxyContin, in the government’s latest attempt to reduce overdose deaths caused by the long-acting medications.

The changes announced Tuesday are designed to remind doctors and patients about the fatal risks of misusing and abusing long-acting opioid pain relievers, which include forms of oxycodone, morphine and other narcotic medications. The new label emphasizes that the drugs are only for patients with “around-the-clock” pain that cannot be treated with over-the-counter medications or immediate-release opioids.

“These labeling changes describe more clearly the risks and safety concerns associated with `extended release and long-acting’ opioids and will encourage better, more appropriate, prescribing, monitoring and patient counseling practices involving these drugs,” the FDA’s Dr. Douglas Throckmorton said in a statement.

ADVERTISEMENT
0 seconds of 0 secondsVolume 0%
Press shift question mark to access a list of keyboard shortcuts
00:00
00:00
00:00
 

The new label also includes a boxed warning about the risks of opioid withdrawal syndrome in infants who are exposed to the drugs during pregnancy, labor and nursing. Symptoms may include rapid breathing, trembling and poor feeding habits.

The FDA is also requiring manufacturers of the targeted products to conduct long-term studies tracking rates of misuses, abuse, addiction and death among patients.

Opioids are drugs that simulate the effects of natural narcotics, such as the opium poppy. They are typically prescribed for people already taking pain medications, including cancer patients, to treat severe pain flare-ups.

The FDA has issued a number of warnings about the dangers of prescription pain relievers in recent years, but with little effect. Inappropriate use of opioids caused more than 16,650 overdose deaths in 2010, up more than 12 percent from 2008, according to the Centers for Disease Control and Prevention.

Earlier this year the CDC reported that prescription painkiller overdose deaths among women increased about fivefold 1999 to 2010. Among men, such deaths rose about 3 1/2 times. The rise in both death rates is closely tied to a boom in the overall use of prescribed painkillers.

The most prescribed medication in the U.S. last year was the opioid combination pill Vicodin and its generic equivalents, according to IMS Health. U.S. pharmacies dispensed the medication, which combines hydrocodone and acetaminophen, over 135 million times in 2012. However, Tuesday’s announcement does not affect Vicodin because it uses an immediate release formulation.

The products targeted by the FDA feature extended-release formulations designed to give long-lasting effects. But that potency carries serious risks when doctors prescribe them inappropriately, and when patients abuse them as stimulants.

The FDA reports that many physicians prescribe the painkillers for unapproved uses, such as treating migraine headaches. Patients will also sometimes chew extended-release pills that are designed to be swallowed, causing an overdose.

Talk to us

> Give us your news tips.

> Send us a letter to the editor.

> More Herald contact information.

More in Local News

(City of Everett)
Everett’s possible new stadium has a possible price tag

City staff said a stadium could be built for $82 million, lower than previous estimates. Bonds and private investment would pay for most of it.

Jennifer Humelo, right, hugs Art Cass outside of Full Life Care Snohomish County on Wednesday, May 28, 2025 in Everett, Washington. (Olivia Vanni / The Herald)
‘I’ll lose everything’: Snohomish County’s only adult day health center to close

Full Life Care in Everett, which supports adults with disabilities, will shut its doors July 19 due to state funding challenges.

The age of bridge 503 that spans Swamp Creek can be seen in its timber supports and metal pipes on Wednesday, May 15, 2024, in Lynnwood, Washington. The bridge is set to be replaced by the county in 2025. (Ryan Berry / The Herald)
Snohomish County report: 10 bridges set for repairs, replacement

An annual report the county released May 22 details the condition of local bridges and future maintenance they may require.

The Edmonds City Council gathers to discuss annexing into South County Fire on Tuesday, Dec. 3, 2024 in Edmonds, Washington. (Olivia Vanni / The Herald)
Community group presents vision for Edmonds’ fiscal future

Members from Keep Edmonds Vibrant suggested the council focus on revenue generation and a levy lid lift to address its budget crisis.

Cars drive along Cathcart Way next to the site of the proposed Eastview Village development that borders Little Cedars Elementary on Wednesday, May 7, 2025 in unincorporated Snohomish, Washington. (Olivia Vanni / The Herald)
Former engineer: Snohomish County rushed plans for Eastview development

David Irwin cited red flags from the developers. After he resigned, the county approved the development that’s now stalled with an appeal

People listen as the Marysville School Board votes to close an elementary and a middle school in the 2025-26 school year while reconfiguring the district’s elementary schools to a K-6 model on Wednesday, Jan. 22, 2025 in Marysville, Washington. (Olivia Vanni / The Herald)
Marysville schools audit shows some improvement

Even though the district still faces serious financial problems, the findings are a positive change over last year, auditors said.

Outside of the Madrona School on Monday, Aug. 26, 2024 in Edmonds, Washington. (Olivia Vanni / The Herald)
Sewer district notifies Edmonds schools of intent to sue

The letter of intent alleges the school district has failed to address long-standing “water pollution issues” at Madrona K-8 School.

Raul Benitez Santana in the courtroom Wednesday. (Will Geschke / The Herald)
Jury convicts driver in death of Washington State Patrol trooper

The jury took four hours Wednesday to find Raul Benitez Santana guilty of vehicular homicide and vehicular assault.

Lake Stevens honors council member who died in office

Marcus Tageant, 52, served on the Lake Stevens City Council for more than a decade. He died on May 26.

Community members gather for the dedication of the Oso Landslide Memorial following the ten-year remembrance of the slide on Friday, March 22, 2024, at the Oso Landslide Memorial in Oso, Washington. (Ryan Berry / The Herald)
The Daily Herald garners 6 awards from regional journalism competition

The awards recognize the best in journalism from media outlets across Alaska, Idaho, Montana, Oregon and Washington.

Edmonds Mayor Mike Rosen goes through an informational slideshow about the current budget situation in Edmonds during a roundtable event at the Edmonds Waterfront Center on Monday, April 7, 2025 in Edmonds, Washington. (Olivia Vanni / The Herald)
Edmonds mayor recommends $19M levy lid lift for November

The city’s biennial budget assumed a $6 million levy lid lift. The final levy amount is up to the City Council.

Amit B. Singh, president of Edmonds Community College. 201008
Edmonds College and schools continue diversity programs

Educational diversity programs are alive and well in Snohomish County.

Support local journalism

If you value local news, make a gift now to support the trusted journalism you get in The Daily Herald. Donations processed in this system are not tax deductible.