FDA Announces New Safety Measures for Narcotic Painkillers
Label warnings designed to limit use of extended-release, long-acting drugs like Oxycontin
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The syndrome develops in the womb among infants exposed to narcotics and can be life-threatening, the agency said. Symptoms can include poor feeding, rapid breathing, trembling, and excessive or high-pitched crying.
In addition, the FDA is requiring makers of these drugs to conduct new studies and clinical trials to assess the risks of misuse, abuse, increased sensitivity to pain, addiction, overdose and death associated with these medications when used for a long time.
When the wording on the labels is finalized, these changes will also become part of the FDA's strategy to evaluate and mitigate risk, which requires companies to provide educational programs to doctors on how to safely prescribe these drugs.
In addition, companies are required to offer patient medication guides on the safe use, storage and disposal of these narcotic painkillers.
Substance abuse and addiction expert Janina Kean, president and CEO of High Watch Recovery Center in Kent, Conn., said she welcomes "the order for stronger labeling, but believes more needs to be done to reduce overdose deaths -- and to help prevent people from becoming addicted."
She said she'd like to see the FDA "designate specific criteria or a list of chronic pain issues for which opioids can be prescribed."
"Twenty to 25 years ago these drugs didn't even exist, and they keep making them stronger and stronger and I can't understand why," Kean stated. "Today we're prescribing Oxycontin for dental work when we should be using painkillers like Darvocet or Tylenol with codeine, which are more mild and not as readily addictive."