Ninety percent of all opioid prescriptions are for these fast-acting, or immediate-release, formulations.
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The FDA plans to add a black boxed warning label to all of the immediate-released opioid painkillers, which includes some 175 branded and generic drugs.
FILE – In this August 5, 2010, file photo, a pharmacy technician poses for a picture with hydrocodone and acetaminophen tablets, also known as Vicodin, at the Oklahoma Hospital Discount Pharmacy in Edmond, Okla. Federal health regulators will bolster warning labels on the most widely used prescription painkillers, part of a multi-pronged federal effort to reverse an epidemic of abuse and death tied to drugs like Vicodin and Percocet, the FDA announced Tuesday, March 22, 2016.
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 diagnosis constraints.
The new labels update information about dosage for the patient including the size of the initial dose, how to monitor patients using opioids and a warning not to abruptly stop treatment for a physically dependent patient. The FDA said it was reviewing such a warning. The primary impact, however, is left with clinicians who prescribe the medication.
“We know that there is persistent abuse, addiction, overdose mortality and risk of NOWS associated with IR opioid products”, said Douglas Throckmorton, M. D., deputy center director of regulatory programs, FDA’s Center for Drug Evaluation and Research. The labeling switch means both drug types will now carry bold warnings about the risks of abuse, overdose and death.
But lawmakers from states that have been plagued by opioid addiction said such labeling changes have “done little” to stem the problem.
In 2013, the FDA required similar labeling on all extended-release / long acting opioids. They will also warn that chronic use during pregnancy can cause newborns to suffer potentially deadly withdrawal symptoms. “This should help improve prescribing practices in the near term”.
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The FDA’s announcement comes just a week after the Centers for Disease Control and Prevention published new prescribing guidelines on opioids to curb an overdose epidemic that the CDC has linked to increased prescribing and sales of opioids. Califf was recently confirmed as the FDA’s leader, but not before some senators delayed the nomination over drug safety concerns. “The plan is focused on policies aimed at reversing the epidemic, while still providing patients in pain access to effective relief”. At the hearing, a White House official said prescription drug monitoring programs are an important tool to reduce opioid overdose deaths.
