FDA Institutes New Label Requirements in Response to Opioid Crisis

FDA Institutes New Label Requirements in Response to Opioid Crisis

As 2018's first month draws to a close, it is now difficult to refer to the crisis of opioid addiction in the U.S. as anything other than a pandemic. The broad-sweeping issue affects far more than the estimated 12 million addicts who abused opiate-containing prescription drugs or heroin in 2016 – the most recent year for which comprehensive data is available, per the National Institute on Drug Abuse: One must also take into account the tens of millions of Americans who make up addicts' families, as well as these individuals' spouses, partners or friends. 

"New FDA regulations will require prescription cold medicines to feature its most serious abuse and overdose warnings."

Federal and state agencies have, in the last few years as opioid abuse increased exponentially, enacted a number of initiatives designed to treat current addicts, support those in recovery and foster prevention campaigns to mitigate the likelihood of future addiction. The Food and Drug Administration announced one of the newest such policies two weeks into January 2018, just before releasing its Strategic Policy Roadmap for this year.

This change, an adjustment of labeling regulations to various medicines (particularly those marketed toward children), will cause significant reverberations throughout the pharmaceutical sector. It will behoove affected companies in the field to update their label finishing equipment and label printers and thus ensure they remain compliant with new product labels.

Prioritizing Children's Safety

Protecting the well-being of children is the primary purpose of the revised pharma labeling standards. According to the FDA's press release on the matter, all prescription cold and cough medications containing hydrocodone or codeine – especially liquid medicines like Promethazine – will feature specific label instructions stating that they shouldn't be used to treat children and adolescents younger than 18 years old.

These drugs must also now feature the biggest caution label placed on the packaging of legal drugs in the U.S.: the agency's "Boxed Warning," which warns users of life-threatening risks. For codeine and/or hydrocodone, the label must specify that the opioid substances can slow down breathing to a potentially lethal degree, and also prominently mention the drugs' habit-forming potential and overdose hazards. 

FDA institutes new label requirements in response to opioid crisisPrescriptions containing codeine will now be labeled with the same warnings as oxycodone and other major opiates.

Comparing Prescription Cold Medications with Pain-Relief Opiates

Finally, the safety information on codeine- and hydrocodone-based cough medicines must now be identical to warnings found on immediate-release versions of the prescription drugs most readily associated with the opioid crisis: oxycodone, morphine, methadone, buprenorphine, pure hydrocodone and others. FDA Commissioner Scott Gottlieb, MD, elaborated on this in a written statement included with the release.

"We know that any exposure to opioid drugs can lead to future addiction," Gottlieb stated. "It's become clear that the use of prescription, opioid-containing medicines to treat cough and cold in children comes with serious risks that don't justify their use in this vulnerable population … At the same time, we're taking steps to help reassure parents that treating the common cough and cold is possible without using opioid-containing products." 

What it Means for Pharma Producers

Because the cold medicines that employ hydrocodone and codeine aren't available on store shelves, there has never been a concern about the drugs being directly or tacitly marketed to youth. In that respect, pharma companies are off the hook.

Otherwise, though, they'll need to adjust their labeling to include the newly mandated FDA warning and be precise about the phrasing. The changes took immediate effect, so even if companies don't intentionally leave labeling unaltered, a surprise FDA audit could lead to civil or criminal penalties. Label printers capable of reproducing the fine print necessary for medicine containers will be perfect for this need, so company leaders should consider browsing the DuraFast Labels U.S. e-commerce website to find what they need.

Leave a Comment