Health & Medicine
FDA Issues New Labeling Guidelines for Longer Acting Painkillers
Samantha Goodwin
First Posted: Sep 16, 2013 04:25 AM EDT
The U.S. Food and Drugs Administration has issued a new set of labeling guidelines for manufactures providing prescribed longer acting painkillers.
Drug overdose death rates in the United States have more than tripled since 1990. They have never been higher. Few years ago, more than 36,000 people died from drug overdoses, and most of these deaths were caused by prescription drugs, especially opoids.
In response to the increasing number of deaths related to drug overdose, the Food and Drugs Administration (FDA) has issued a new set of labeling guidelines for manufactures that provide prescribed longer acting painkillers. The administration hopes that this new set of labeling guidelines will help encourage safer use of opoids by more responsible and educated prescribing by medical providers.
"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," said Douglas Throckmorton, M.D., deputy director of regulatory programs in FDA's Center for Drug Evaluation and Research.
According to the new guidelines, the label should clearly mention the risks of opoid use during pregnancy with potential for development of neonatal opioid withdrawal syndrome (NOWS) in a boxed warning- the highest level warning issued by the FDA.
The "limitations of use" portion of the new labeling retains language indicating that the drugs are not intended for use as an "as-needed" pain reliever.
"Because of the risks of addiction, abuse and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve [Tradename] for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain," the administration said.
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First Posted: Sep 16, 2013 04:25 AM EDT
The U.S. Food and Drugs Administration has issued a new set of labeling guidelines for manufactures providing prescribed longer acting painkillers.
Drug overdose death rates in the United States have more than tripled since 1990. They have never been higher. Few years ago, more than 36,000 people died from drug overdoses, and most of these deaths were caused by prescription drugs, especially opoids.
In response to the increasing number of deaths related to drug overdose, the Food and Drugs Administration (FDA) has issued a new set of labeling guidelines for manufactures that provide prescribed longer acting painkillers. The administration hopes that this new set of labeling guidelines will help encourage safer use of opoids by more responsible and educated prescribing by medical providers.
"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," said Douglas Throckmorton, M.D., deputy director of regulatory programs in FDA's Center for Drug Evaluation and Research.
According to the new guidelines, the label should clearly mention the risks of opoid use during pregnancy with potential for development of neonatal opioid withdrawal syndrome (NOWS) in a boxed warning- the highest level warning issued by the FDA.
The "limitations of use" portion of the new labeling retains language indicating that the drugs are not intended for use as an "as-needed" pain reliever.
"Because of the risks of addiction, abuse and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve [Tradename] for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain," the administration said.
See Now: NASA's Juno Spacecraft's Rendezvous With Jupiter's Mammoth Cyclone