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Thursday, October 24, 2013

FDA Proposes Changes in Pain Medication Prescriptions

The US FDA has announced proposed changes will be forthcoming in labeling for pain relief medication:
Consumers and health care professionals will soon find updated labeling for extended-release and long-acting opioid pain relievers to help ensure their safe and appropriate use.
"In addition to requiring new labeling on these prescription medications, the Food and Drug Administration (FDA) is also requiring manufacturers to study certain known serious risks when these drugs are used long-term.
"The new labeling requirements and other actions are intended to help prescribers and patients make better decisions about who benefits from the use of these medications.

They also are meant to reduce problems associated with their use," says Douglas Throckmorton, M.D., deputy director of regulatory programs in FDA's Center for Drug Evaluation and Research. "Altogether, the actions we're now announcing are part of FDA's efforts to make opioids as safe as possible for those who need them," Throckmorton adds.
"He noted that the actions come after careful analysis of new safety information, including reviews of medical literature, and consideration of input from patients, experts and many other interested parties.