FDA Requires All Rx Opioid Labeling Warn About Risks of Long-Term Use

FDA Requires All Rx Opioid Labeling Warn About Risks of Long-Term Use

The Food and Drug Administration is overhauling the safety labeling requirements for opioid analgesics, citing new evidence that problematic use and overdose are associated with taking the medications as a maintenance regimen. The FDA announced the mandate July 31, and manufacturers are expected to update their labeling and submit the new versions for review by August 30.  “Tragically, the new drug application for OxyContin was initially approve…

FDA Takes Steps to Restrict 7-OH Opioid Products Threatening American Consumers

The U.S. Food and Drug Administration is taking a bold step to protect Americans from dangerous, illegal opioids by recommending a scheduling action to control certain 7-hydroxymitragynine (also known as 7-OH) products under the Controlled Substances Act (CSA). The FDA is specifically targeting 7-OH, a concentrated byproduct of the kratom plant; it is not focused on natural kratom leaf products. Continue reading FDA Takes Steps to Restrict 7-OH …

FDA Addresses Opioid Medication Safety With Additional Label Changes

The FDA also recommended a scheduling action for 7-hydroxymitragynine (7-OH), with data showing the drug binds to opioid receptors.