The move is part of an effort to educate the public and slow down the prescription drug abuse epidemic in the United States, according to the FDA announcement.
There are two main classes of opioid painkillers, reports CNN, extended-release, which means there is more opioid pain medication per dose, and immediate release, which has less opioid medication per dose. The majority of prescriptions written in the U.S. are for immediate release opioids.
The “black box” warning is the FDA’s strongest warning and is meant to educate doctors as they prescribe painkillers to patients. The FDA even has a description of how the prescribing of a painkiller will play out, for the patient’s benefit.
When a patient goes to get his or her prescription filled at a pharmacy. they get the medication, and it will have a notification that indicates it has a “black box” warning. To access that warning, the patient will need to go to the manufacturer’s website for details, according to KFOR.com.
Pharmacists are also involved in the education of the public about the risks involved in opioid painkillers. Pharmacies are being encouraged to hand out a medication guide, using consumer-friendly language, explaining the risks of the drug. The FDA wants all immediate release drugs to have a medication guide, but, again, it is up to the pharmacies.
Not the first time the FDA has used a warning
In 2013, the FDA placed a similar “black box” warning on extended-release painkillers, despite a push from public health officials and legislators that all painkillers needed a warning label. The FDA, at the time, felt that only the extended-release painkillers needed the warning because of the abuse and addiction problem.
“The higher dose strength of the extended release was more attractive for abusers,” FDA commissioner Dr. Robert Califf said. But after that initial action, “we followed the data on misuse … we continue to see misuse and death.”
Digital Journal reported in December 2015 that 24.6 million people — that’s 9.4 percent of the American population 12 years of age and older — were living with “substance dependence or abuse” in 2015, according to the American Society of Addiction Medicine (ASAM).
At the same time, the CDC announced the proposed new guidelines for the prescribing of opioid painkillers, but the agency’s move was met with stiff opposition from drug companies, industry-funded groups, and some public health officials. After a public comment period of 30 days, the guidelines were finally released earlier this month.
The FDA’s move to put a “black box” notification on opioid painkillers is “too little, too late,” according to Sen. Ed Markey, a Democrat from Massachusetts. “Unfortunately, it has taken FDA far too long to address the grave risks of these drugs that have claimed the lives of thousands this year alone,” Markey said in a statement.
