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Black Box Warning and Prescription Drugs

For many people, the phrase “black box” conjures images of emergency officials searching for a downed airplane’s flight recorder in hopes of discovering just what exactly caused the accident.

There is, however, another type of black box. The Federal Food and Drug Administration, the agency responsible for approving medications for the public at large, also employs a black box.

Black Box Warning on Prescriptions

Black Box Warnings are issued by the FDA on medications proven to pose the risk of addiction, severe side effects and, if misused or abused, fatal overdoses.

These notices are the most serious warning the FDA includes for medications that are viable treatments for some diseases or illnesses, but may create serious adverse reactions in some patients, if prescribed or used incorrectly.

What are Examples of Drugs With Black Box Warnings?

The medications listed here, prescribed for mental health conditions, all have black box warnings:

  • Abilify – a drug often prescribed for depression, bipolar disorder and schizophrenia has a warning that it can cause suicidal thoughts in young people who use it
  • Cymbalta – normally prescribed for depression and the treatment of anxiety may increase the risk of suicide
  • SSRIs and SNRIs – selective serotonin re-uptake inhibitors and serotonin and norepinephrine reuptake inhibitors commonly prescribed for people battling depression has shown to put children at risk of suicide
  • Risperdal – a medication used in the treatment of schizophrenia and bipolar disorder has shown to put elderly patients at the risk of death

One controversy surrounding black box notices is that some medications, initially, come without them. Oxycodone, a prescription opioid painkiller in the same class of opiates contributing to the surge in heroin addiction, is a case in point.

When Did the FDA Begin Requiring Black Box Warnings?

Not until June 2016 did the FDA announce it will require black box warnings on the drug. Unlike time-release opioid medications, certain painkillers immediately release the painkilling opioid formulation.

Typically, these medications contain less opioid, but require patients to take them more often. The FDA’s policy change this year requires all immediate-release medications to carry a black box warning.

When patients receive a prescription with a black box warning, pharmacists are encouraged to provide a medication guide written in language understandable to the non-medical professional. Consumers can also visit the drug maker’s website for more information on possible side effects of the medication.

It wasn’t until 2013 that the FDA required black box warnings on extended-release painkillers, which contain a greater concentration of opioids, and are meant to be taken less often. FDA officials felt the warning might actually cause more harm than good, making the stronger medication more attractive to those that might be inclined to abuse the drug. Some officials are unhappy that it’s taken the FDA so long to act, especially where opioids are concerned.

“Too little, too late,” said Massachusetts Democratic Senator Ed Markey in a statement. “Unfortunately, it has taken the FDA far too long to address the grave risks of these drugs that have claimed the lives of thousands this year alone.”

As the Centers for Disease Control and prevention notes, 259 million prescriptions for opioid painkillers were written in 2012 alone, enough for every adults in the United States to have a bottle of the highly addictive medication.

New guidelines released by the CDC suggest non-opioid therapy for pain should be the first step, and if opioid painkillers are necessary, the lowest possible dose should be prescribed.

More and more information is available to patients about medications their doctors prescribe. Taking the time to do even a little research about the side effects or the likelihood of addiction to a particular prescription, whether it comes with a black box warning or not, might prevent any unintentional and negative consequences.


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