A group of US Congress members are pushing expanded FDA packaging regulations for opiates. The 22 lawmakers are calling for packaging of immediate-release opiates to carry the same labeling as those found on packages containing extended-release versions of the drugs.
In a letter to FDA Commissioner Dr. Stephen Ostroff, the congresspeople wrote:
“Given the national public health crisis of prescription drug overdoses… we believe this common sense approach would equip patients and prescribers with information necessary to make informed decisions regarding the risks of opioid analgesics.”
The proposed labeling—known as “black box” warnings—varies from drug to drug, but consistently carries information concerning proper use and the risks of improper use, including addiction, death and neonatal addiction syndrome. According to Health Commissioner Dr. Harry Chen—who supports the label expansion—the “black box” warning is the strongest form of labeling mandated by the FDA.
According to the FDA, immediate-release opiates have accounted for 90 percent of opiate prescriptions since 2009. Generally, immediate-release opiates are prescribed for patients experiencing short-term pain, while extended-release opiates are prescribed for patients with chronic, long-term pain.