FDA To Slap ‘Strongest’ Warnings On Painkillers – ‘Black Box’ Labels To Caution Against Risk Of Drug Abuse, Overdose, Addiction, And Death

The FDA will slap their “strongest” warnings on painkillers. The “Black Box” labels are a desperate attempt to curtail the abuse, overdose, addiction, and death due to drugs.

Federal health regulators have decided to attach their strongest warning labels to the most widely used class of prescription painkillers. The black box warnings will be mandatory for the “immediate-release opioid painkillers” and will help in highlighting the risk of drug abuse, addiction, overdose, and death. The government announced the labels are part of a multi-pronged approach to reduce the growing epidemic of deaths arising out of drug abuse that are being linked to painkillers.

The black box warnings are meant to educate and caution the doctors as they are the ones prescribing such powerful medications to patients. According to the announcement on Tuesday, there will be a boxed warning attached to all the immediate-release opioid painkillers. Currently, there are about 175 branded and generic drugs which fall under this category of painkillers, most notable being Vicodin and Percocet. Speaking about the decision to slap warnings on painkillers, FDA Commissioner Dr. Robert Califf said the following.

“We’re at a time when the unfathomable tragedies resulting from addiction, overdose and death have become one of the most urgent and devastating public health crises facing our country. I can’t stress enough how critical it is for prescribers to have the most current information.”

Currently, there are primarily two types of prescription opioid painkillers. There’s “extended release,” which packs a strong pain-killing opioid per dosage and the second one is “immediate release.” The extended release takes a little longer to take effect but needs to be taken after a long interval. As the name suggests, the immediate release opioid painkillers are quick to take effect and even pack a relatively minuscule dosage. The only drawback of immediate release opioids is that they need to be taken in very small intervals.


Needless to say, there’s a huge market for the immediate release opioids. They roughly account for 90 percent of opioid prescriptions, noted the FDA. These commonly prescribed medications in the U.S. often combine oxycodone with lower-grade medications. According to the Charleston Gazette Mail, prescription opioids accounted for over $9 billion in sales last year for companies like Teva Pharmaceuticals, Johnson & Johnson’s Janssen Pharmaceutical, Purdue Pharma, and others.

As expected, these drugs have a very high chance of being abused that might result in an overdose. Addiction is a very common problem with painkillers. According to the Centers for Disease Control and Prevention, almost 19,000 people died due to misuse and abuse of prescription opioids in 2014. In fact, overdosing on heroin and opioid painkillers has been collectively responsible for the deaths of almost 29,000 people.


Opioids are a class of powerful and highly addictive drugs that include both prescription drugs like codeine and hydrocodone, as well as illegal narcotics, like heroin, reported Chron. Unfortunately, American doctors aren’t mandated by law to follow the FDA’s instructions on drug labels. Nonetheless, medical professionals involved with hospitals, medical groups, and insurers often treat these instructions as primary guidelines.

How will the Black Box warning labels work? Since doctors aren’t bound by law, the onus of observing the labels and their warnings falls on the patient. As per the announcement by the FDA, when a patient gets his or her prescription filled, the bottle should have a notification indicating there is a black-box warning for the drug, reported Fox 8. The end-user of the prescribed drug will have to visit the manufacturer’s website to obtain the relevant cautionary and warning messages.


The black box label could hopefully alert the pharmacist to voluntarily offer more information on the opioid-based painkiller that has been prescribed to the patient. The FDA encourages the pharmacist to maintain a “medication guide” and dispense information along with the painkiller.

Extended release painkillers have had these warnings since 2013. While health experts have long stressed that all painkillers should feature such warnings, the FDA felt it wasn’t necessary for immediate-release opioid painkillers, until now.

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