FDA announces new labeling rules for opioid painkillers, including oxycodone

September 10, 2013

The Food and Drug Administration on Tuesday announced that it will require starker warning labels on OxyContin and certain other narcotic painkillers, known as opioids, as part of an effort to combat the rampant addiction and misuse that lead to thousands of deaths each year.

The agency said the labeling changes would apply to all extended-release and long-acting opioid painkillers. The most widely used of those includes oxycodone, which can be found in OxyContin and similar drugs.

“FDA is extremely concerned about the inappropriate use of opioids, which has reached epidemic proportions in the United States and has become a major public health challenge,” FDA commissioner Margaret A. Hamburg told reporters Tuesday.

At the same time, she added, “We must also recognize the medical value they have for many patients living with pain. Therefore, the agency must strike a balance between their benefit in treating patients with pain and the risks associated with misuse, abuse, addiction, overdose and death.”

Tuesday’s announcement marks the latest chapter in an ongoing, impassioned debate in the public health community about the proper role for opioids.

For years, doctors typically prescribed them only to patients in acute pain, such as cancer patients. But over the past decade, in part due to research generated by drug companies and pain specialists downplaying the risks of opioids, the prescription and use of painkillers skyrocketed, as they became a relatively common treatment for everything from back pain to arthritis.

With that increase has come an epidemic of addiction to the powerful painkillers, as well as a rise in their illicit use. A 2009 National Survey on Drug Use and Health found that about 2 million Americans were hooked on or abusing prescription pain relievers, numbers that eclipsed those for both cocaine or heroin.

The balance the agency tried to strike on Tuesday involves requiring new labels stating that the drugs are intended for the management of pain “severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.” The warnings, which will take effect in coming months, will say that because of the risks of addiction, abuse and misuse — even for patients who use the drug as directed — opioids should be used only for patients for whom other treatments are not sufficient.

That approach represents a departure from current labeling, which focuses more on the severity of patients’ pain rather than their conditions or the overall treatment they might need, said Douglas Throckmorton, deputy director for regulatory programs in the FDA’s Center for Drug Evaluation and Research. Current labeling recommends use for patients with “moderate to severe” pain.

Throckmorton said FDA officials hope the revised labeling will lead physicians and patients alike to be “more thoughtful and more careful” before using the powerful medications. “The goal here was to make every patient who taking an opioid and their prescriber have a long conversation about whether [the drugs] benefit them as individuals,” he said, adding, “This new labeling is also going to highlight some of the risks in ways we haven’t previously.”

The FDA said Tuesday it also intends to require drug companies to conduct more studies and clinical trials to further assess the risks of opioid painkillers. Specifically, agency officials are interested in determining whether using opioids at certain dosages or for certain durations is more likely to trigger addiction.

The agency also will require a new boxed warning on the drugs cautioning that chronic maternal use during pregnancy could result in neonatal opioid withdrawal syndrome, a life-threatening condition.

Purdue Pharma, the maker of OxyContin, noted in a statement Tuesday that it had reformulated the drug in 2010 in an effort to deter tampering and misuse, and that it supports efforts such as prescription-drug monitoring.

“We recognize the importance of providing updated safety information about opioid drug products to healthcare professionals,” the company said. “The changes announced by the FDA today are part of that process. We are reviewing the labeling changes and requirements for additional studies outlined in the FDA letter and will respond to the FDA.”

In a report this year, the Centers for Disease Control and Prevention said that while deaths from drug overdoses had increased steadily in the decade ending in 2010, deaths attributable to opioid pain relievers increased fivefold for women between 1999 and 2010, and 3.6 times for men.

In 2010, the CDC said, 16,651 died from overdoses involving opioids. That same year, the agency said enough opioid pain relievers were sold to medicate every adult in the United States with the typical dose of 5 milligrams of hydrocodone every four hours for a month — a 300 percent increase from barely a decade earlier.

Last year, a group of dozens of doctors known as Physicians for Responsible Opioid Prescribing pushed the FDA to revisit its labeling requirements, among other actions.

“It’s a good thing,” Stuart Gitlow, the president of the American Society of Addiction Medicine and one of the signers of that petition, said of the agency’s announcement Tuesday. “You don’t want to tie the hands of people who prescribe the drugs for patients who truly need them. But you do want to send a message to the doctors who are writing these particular prescriptions in too high dosages or for too long a period of time.”

Brady Dennis is a national reporter for The Washington Post, focusing on food and drug issues.
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