To curb the narcotic epidemic, the Food and Drug administration announced on Tuesday that it will require additional warnings on the risks of addiction, abuse, and overdose on prescription labels, according to a Washington Post report. Warnings of immediate-release opioid medications will also include cautions to newborns who must suffer an excruciating withdrawal process known as Neonatal Opioid Withdrawal Syndrome.
FDA Commissioner Robert Califf in a release described opioid addiction as one of the most “urgent and devastating public health crises facing our nation” and adding more warnings was just part of a layered strategy in addressing the concern on the heels of criticism for not taking enough initiative to counter the abuse.
The new roll-out will emphasize that immediate-release opioids should be sourced as a last measure when other substitutes don’t work or can’t be administered because of diagnostic constraints. Dosing specifics for prescribers will be more detailed in how to dispense the medication and monitor patients with an additional warning to not “abruptly stop treatment in a physically dependent patient.”
These new precautions will affect more than 200 short-acting narcotic medications including widely prescribed opioids, such as oxycodone, hydrocodone among the 87 brand-name drugs and 141 generics, which dominate 90 percent of the market. Related warnings were labeled on packaging for extended-release meds in 2013, said Douglas Throckmorton, deputy director of regulatory programs for the FDA’s Center for Drug Evaluation and Research. The new labels should be completed by
The new labels should be completed by the end of 2016, after which drug manufacturers will be ordered to single out warnings and refresh guidelines; current packages will not be recalled.
Bill Soller, president of Biomedical Regulatory Consulting in Houston, an expert on drug labeling when he was a professor at UC San Francisco, believes in the “comprehensiveness” of the FDA strategy. The primary impact, however, is left with clinicians who prescribe the medication.