WASHINGTON — The Food and Drug Administration on Tuesday announced changes to the labeling requirements for long-acting painkillers, in a further effort to curb prescription drug abuse, which now takes more American lives than car accidents or gunshot wounds.
Agency officials said the labeling changes, set to take effect by the end of the year, would "help improve the thoughtful prescribing of these medicines," which include OxyContin, a highly addictive opioid that has figured prominently in the abuse epidemic. Morphine and fentanyl are other examples.
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 that he was pleased by the announcement, but that he would have liked the agency to have gone further, for example by defining limits on the duration of use and dosage.
A major issue hanging over opioid use is a lack of data about the drugs' long-term risks and effectiveness. Dr. Throckmorton said the agency was trying to address that by telling producers that they had to run studies and clinical trials on drugs currently on the market to better assess the risks. In a letter sent to drug makers, the agency said that companies would also have to perform other studies, including one examining whether patients on opioids develop increased sensitivity to pain.
The next step, Dr. Throckmorton said, is "a series of conversations" with manufacturers of such drugs "about what those studies and trials will look like." He expects to start receiving information in 2015.
Dr. Erin E. Krebs, a pain researcher at a Department of Veterans Affairs facility in Minneapolis, said that "it would be fabulous" to have such data so that doctors could better understand how or whether they should be prescribing opioids for long periods.
Dr. Nathaniel Katz, an assistant professor of anesthesia at Tufts University School of Medicine in Boston, said he was skeptical that the labeling changes would have much of an effect, because they represented current practice. But he said the requirement that companies conduct studies was a major advance.
"We can't possibly prescribe these drugs knowledgeably unless we know what the incidence is of serious and fatal complications," he said.
Barry Meier contributed reporting from New York.
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