The FDA has unveiled enhanced warnings for opioid pain medications that will affect 141 generic and 87 innovative immediate-release opioid products, which account for roughly 90 percent of all prescription opioids.
The new boxed warning covers the risks of misuse, abuse, addiction, overdose and death. Labeling was updated due to the increasing number of reports of abuse and misuse, agency officials told reporters during a conference call last week.
The updated information clarifies that because of these risks, IR opioids should be reserved only for patients suffering severe pain for whom there are no other treatment options, the FDA says.
Dosing information also will be clearer, providing instructions on the initial dosage, dosage changes during therapy and a warning to refrain from abruptly stopping treatment in a physically dependent patient.
To know more, attend this session “FDA’s New Labeling Requirements for Opioids ” with expert speaker Dr. David Lim – Ph.D., RAC, ASQ-CQA, who is President and Principal of Regulatory Doctor (www.RegulatoryDoctor.US). As a leading industry speaker, Dr. Lim frequently presents global regulatory and quality compliance topics including regulatory submissions, GLP, GCP and GMP matters in various forums and meetings. Recently, Dr. Lim developed 510(k) and PMA templates ready for use compliant with e-Copy and RTA policy, will provide great opportunities to become aware of and get familiar with FDA’s new requirements for opioid labeling changes. In this conference, David will also discuss what firms should consider and implement the good practices compliant with the FDA’s recommendations so that FDA enforcement actions can be avoided.
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