FDA to require strongest warning on some opioid painkillers

Federal health officials strengthened drug label warnings for addictive painkillers on Tuesday and called for more addiction treatment, citing continuing overdoses and a drug abuse epidemic that is "blurring" into a heroin epidemic.

All immediate-release opioid painkillers will now feature a highlighted warning about the serious risks of misuse, abuse, addiction, overdose and death, the U.S. Food and Drug Administration said Tuesday. Those drugs, sold as Vicodin and many generic brands, are consistently among the most prescribed drugs in the U.S.

The long-awaited change comes roughly three years after the FDA added bolder warnings to long-acting opioid drugs like OxyContin, which slowly release their doses over 12 hours or more.

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.

The recommendations are being released as Congress grapples with legislation aimed at helping medical providers and local governments combat heroin and painkiller abuse through better public education, treatment for addiction, programs to encourage the disposal of excess drugs and the wider use of overdose antidotes such as Naloxone. As part of the boxed warning, the FDA now requires a precaution that chronic maternal use of opioids during pregnancy can result in neonatal opioid withdrawal syndrome (NOWS), which may be life-threatening if not recognized and treated using protocols developed by neonatology experts. The FDA previously restricted combination pills like Vicodin to limit refills and who can prescribe them.

Last week, the CDC released opioid prescribing guidelines for the first time.

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This story corrects the number of immediate-release opioids affected by the FDA action to 175, not 220.

Doctors are not required to follow the FDA's instructions on drug labels, though they are often used as prescribing guidelines by hospitals, medical groups and insurers.

But, Dr. Caleb Alexander, co-director of the Johns Hopkins Center for Drug Safety and Effectiveness, said "that there is a false dilemma that is posed between reducing opioid use and improving quality of pain care ..."

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. The agency said primary care doctors should only turn to opioids after considering physical therapy, over-the-counter medications, counseling and other methods for treating chronic pain.

Government officials have already tried a variety of approaches to tackling painkiller abuse in recent years.

The FDA is also requiring label changes to all opioid drugs regarding interactions with other medications, decreased levels of sex hormones and adrenal gland issues.