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FDA taking steps to combat opioid abuse, address pediatric labeling :

February 5, 2016

The Food and Drug Administration (FDA) is aiming to curb the opioid abuse epidemic by undertaking a massive review of its policies.

The agency’s plans include convening its Pediatric Advisory Committee to discuss pediatric opioid labeling. It also will take steps to improve prescriber training and access to overdose treatments and abuse-deterrent formulations.

“Things are getting worse, not better, with the epidemic of opioid misuse, abuse and dependence,” FDA Deputy Commissioner for Medical Products and Tobacco Robert Califf, M.D., M.Acc., said in a news release. “It’s time we all took a step back to look at what is working and what we need to change to impact this crisis.”

Roughly 44 people in the U.S. die from prescription opioid overdoses each day, and people who are addicted to such drugs are 40 times more likely to develop a heroin addiction, according to the Centers for Disease Control and Prevention (CDC). From 2011-’13, the rate of heroin use among 18- to 25-year-olds doubled compared to the period of 2002-’04.

The FDA’s plan to address the issue includes:

  • studying the risks and benefits of opioids;
  • halting new labeling until it creates a new framework for pediatric labeling in consultation with its Pediatric Advisory Committee;
  • expanding access to opioid products with abuse-deterrent properties and convening an expert advisory committee before approving those without such properties;
  • adding warnings and safety information to immediate-release opioid labeling;
  • improving access to naloxone to treat opioid overdose;
  • supporting better options for managing pain; and
  • improving prescriber training.

The Academy backed the FDA’s recent move to change OxyContin labeling to include 11- to 16-year-olds, which provides data to help prescribers safely treat severe pain. It also expressed support Thursday for the agency’s additional steps to examine opioid use.

“In view of the epidemic of addiction to pain medications, FDA’s plan to review opioid policies is warranted,” said AAP President Benard P. Dreyer, M.D., FAAP. “However, we want to make sure that children who have severe or chronic pain have appropriate access to these medications to ease their suffering. We encourage continued work by the FDA to provide labeling of these medications with appropriate dosing instructions to physicians for children.”

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