US FDA issues new labelling requirements for immediate-release opioids

By Dan Stanton contact

- Last updated on GMT

Image: iStock/ArtTim
Image: iStock/ArtTim

Related tags: Opioid

The US FDA has ordered new labelling changes for immediate-release (IR) opioids but rejects claims that such products pose the same risks as extended-release (ER) opioids.

In February 2014, drugmaker Purdue Pharma submitted a Citizen Petition​ requesting the US Food and Drug Administration (FDA) recognise IR opioid analgesics have the same risks as extended-release and long-acting (ER/LA) opioids.

The petition stemmed from a 2013 FDA mandate​ requiring safety labelling changes and postmarket study requirements solely for ER/LA opioids on the grounds “that there are disproportionate safety concerns associated with these products compared to immediate-release (IR) opioids.”

The Agency submitted a response​ to the petition this week, denying that IR opioids have comparable or higher incidence of risks - including crisis of misuse, abuse, addiction, overdose, and death - than ER/LA opioid analgesics.

New labelling

However, it agreed such analgesics are still very much associated with substantial and continued abuse, and as such has ordered new labelling requirements for IR opioids.

Drugmakers must now include a precaution that chronic maternal use of opioids during pregnancy can result in neonatal opioid withdrawal syndrome (NOWS) on the boxed warning of IR opioid products.

“We know that there is persistent abuse, addiction, overdose mortality and risk of NOWS associated with IR opioid products,”​ deputy center director of regulatory programs at the FDA’s Center for Drug Evaluation and Research (CDER) Douglas Throckmorton said.

“We have taken an important next step in clarifying and making more prominent the known risks of IR opioid medications.”

Extended label requirements

Furthermore, all opioids – both IR and ER/LA – must now include safety information about potentially harmful drug interactions with other medicines that can result in a serious central nervous system condition called serotonin syndrome.

The Agency and the pharma industry have been under pressure to clampdown​ on opioid abuse which is increasingly becoming a problem in the US. 2014 saw a record number of deaths​ from drug overdose, with prescription opioid pain relievers deemed a driving factor.

“Opioid addiction and overdose have reached epidemic levels over the past decade, and the FDA remains steadfast in our commitment to do our part to help reverse the devastating impact of the misuse and abuse of prescription opioids,”​ said FDA Commissioner Robert Califf, welcoming the new requirements.

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