FDA strengthens painkiller warnings to clarify risks as overdoses, abuse surge
WASHINGTON — The Food and Drug Administration is requiring stronger warning labels on prescription painkillers such as OxyContin, in the government's latest attempt to reduce overdose deaths caused by the long-acting medications.
The changes announced on 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. Whereas the previous label recommended the medications for “moderate to severe pain,” the new label describes a more limited role. It says the drugs should only be used for “pain severe enough to require daily, around-the-clock” treatment that cannot be managed with alternatives, such as 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,” said Dr. Douglas Throckmorton of the FDA.
The label 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 requiring manufacturers of the targeted products to conduct long-term studies tracking rates of misuse, abuse, addiction and death among patients.
The action affects about 20 prescription products, including Purdue Pharma's OxyContin, Johnson & Johnson's Duragesic patch and Pfizer's Embeda. Opioids are drugs that simulate the effects of natural narcotics, such as the opium poppy. They are typically prescribed for people 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.
Show commenting policy
TribLive commenting policy
You are solely responsible for your comments and by using TribLive.com you agree to our Terms of Service.
We moderate comments. Our goal is to provide substantive commentary for a general readership. By screening submissions, we provide a space where readers can share intelligent and informed commentary that enhances the quality of our news and information.
While most comments will be posted if they are on-topic and not abusive, moderating decisions are subjective. We will make them as carefully and consistently as we can. Because of the volume of reader comments, we cannot review individual moderation decisions with readers.
We value thoughtful comments representing a range of views that make their point quickly and politely. We make an effort to protect discussions from repeated comments either by the same reader or different readers.
We follow the same standards for taste as the daily newspaper. A few things we won't tolerate: personal attacks, obscenity, vulgarity, profanity (including expletives and letters followed by dashes), commercial promotion, impersonations, incoherence, proselytizing and SHOUTING. Don't include URLs to Web sites.
We do not edit comments. They are either approved or deleted. We reserve the right to edit a comment that is quoted or excerpted in an article. In this case, we may fix spelling and punctuation.
We welcome strong opinions and criticism of our work, but we don't want comments to become bogged down with discussions of our policies and we will moderate accordingly.
We appreciate it when readers and people quoted in articles or blog posts point out errors of fact or emphasis and will investigate all assertions. But these suggestions should be sent via e-mail. To avoid distracting other readers, we won't publish comments that suggest a correction. Instead, corrections will be made in a blog post or in an article.
- Blockbuster snowstorm aims northeast
- Orcas could land on endangered list
- Ramping up e-cigarette voltage may be more hazardous to health
- Navy wants to increase use of sonar-emitting buoys
- Obama to seek protection of wilderness designation for Alaska refuge
- Some Catholics ruled out as jurors in Boston Marathon bombing case
- Santa Ana winds cut power to thousands in Southern California
- Police: Man kills co-worker, then himself at NYC Home Depot
- Lawmakers target gay nuptials as Supreme Court ruling nears
- Arizona hospital tests brain tumor drugs by giving patients dose, then operating
- Massive asteroid will fly by Earth late Monday