FDA Alters Painkiller Label Rules to Cut Abuse

The Food and Drug Administration announced changes to the labeling requirements for long-acting painkillers, in an attempt to cut abuse, according to the New York Times.

This is an effort to further curb prescription drug abuse, which now takes more American lives than car accidents or gunshot wounds. Agency officials said labeling changes, which is slated to commence by the end of the year, would "help improve the thoughtful prescribing of these medicines," which include OxyContin, a highly addictive opioid featured prominently in the abuse epidemic. Morphine and fentanyl are also included.

The agency is also requiring producers of such drugs to conduct studies on the long-term risks of taking them. Researchers applauded the move, saying that a lack of such data was a major problem in determining safe prescribing practices.

At the heart of the changes is a modification of the language on what kind of pain the drugs are supposed to be prescribed for. Current labels say the drugs should be used for moderate to severe pain, an indication that Dr. Douglas Throckmorton, the deputy director for regulatory programs at the F.D.A.'s Center for Drug Evaluation and Research, said was not quite right.

"What is moderate to me could be severe to you," he said. The new language, he said, will say that the drugs should be reserved for use in patients who do not have other treatment options, and be used for management of pain that is "severe enough" to require round-the-clock treatment.

The move was prompted by a petition from Physicians for Responsible Opioid Prescribing, an advocacy group in New York. Dr. Andrew Kolodny, the president of the group, said he was pleased by the announcement, but would have liked the agency to have gone further to include limit definitions on the duration of use and dosage.