FDA sets new limits on use of immediate-release opioids – FiercePharma

After years of criticism that they were not doing enough to fight the growing abuse of opioids, federal authorities are piling on new guidelines and warnings for the powerful painkillers. The is the latest with box warnings about what it called the serious risks of misuse, abuse, addiction, overdose and death.

The agency said that because of the danger that patients can get addicted to drugs like , hydrocodone and morphine, labels would make it clear that immediate-release versions should only be given for severe pain when nonaddictive drugs are not enough. The FDA will provide new cautions about dosing and “a warning not to abruptly stop treatment in a physically dependent patient.” Immediate-release versions make up the vast majority of prescriptions for the painkillers.

The labels also will lay out the fact that there is a risk that the babies of women who take opioids during pregnancy will be born with what is called neonatal opioid withdrawal syndrome (NOWS). The condition can be “life-threatening” so it needs to first be recognized by doctors and then treated using certain protocols established by neonatal experts, FDA said.

“Today’s actions are one of the largest undertakings for informing prescribers of risks across opioid products, and one of many steps the FDA intends to take this year as part of our comprehensive action plan to reverse this epidemic,” the FDA’s new commissioner, Robert Califf, said in the announcement.

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