What is the Black Box Warning?


The U.S. Food and Drug Administration (FDA) monitors, tests and certifies all medications which become available to us on the market.  A black box warning, sometimes referred to as boxed warnings, is the most stern warning that the FDA issues.  They are issued when there are certain serious safety risks related to taking the prescribed medicines.  Though the risk of injury may be relatively small, when compared to the number of people who take the medicine, the injuries can be severe enough to warrant the attention of our doctors, pharmacists and us, the patients.

These warnings communicate to us the potential, albeit rare, but dangerous side effects.  They also inform us of safe usage and a variety of potential factors which might increase an unwanted episode injurious to our health.  The black box warnings are on the outside of the prescription bottle, in bold print, with a black border.  They may also be printed on information sheets inside the packaging.

Warnings Communicate Possible Risk

When we pick up a prescription which has a black box warning, it does not necessarily mean that we should not take the drug.  The warnings are primarily to alert health care professionals, so that they can either discuss the medicine with the patient or at least know what to be aware of if they are already familiar with the patient’s medical history.  Some medicines should not be taken by someone who is pregnant or nursing.

What prompts a black box warning?

All medicines go through clinical trials, wherein the proposed medicine is tested on people who have the malady, or symptoms, which the drug has been designed to treat.  When the trial data is such that the FDA identifies a concern with possible serious outcomes, the manufacturer can be required to state the concern/warning on the labeling of its product.  Again, this does not mean that all people who take the prescribed drug will have a high risk of what is termed an “adverse event.”  It does mean, however, that health care providers and patents alike should be aware of those risks.

Information Available From the FDA

The Guide to Drug Safety Terms at the FDA is an excellent source of information provided to us by our government.  As patients of, presumably, some doctor(s) or another, we have a responsibility to be at least somewhat educated about the medicines we take.  Government agencies use terms which are often stark, direct and sometimes a bit frightening or intimidating.  Such is the nature of the language of government.  We do not have to fear it, and we would do well to learn how we can assist our medical professionals in our own health care.

We also have a responsibility to be aware that our doctors are not omniscient and infallible.  It is not possible for them to remember every risk factor for every patient that they attend to.  If we are taking aspirin for headaches, and our doctor prescribes a blood thinner for us, the onus is on us to make certain that the doctor knows that we take something for headaches.  Aspirin is a blood-thinning agent.  It does not go well with taking a prescription blood thinner. Similarly, if we eat a lot of leafy greens and other green vegetables which are high in vitamin K, which is a blood coagulator, we need to let our doctors know.  Vitamin K works against blood thinners.  But if we do not tell our doctors all that we are taking, then she or he might prescribe something that could harm us.

In short, Dear Reader, black box warnings are there to protect us from unwanted side effects from medicines we ingest.  Most of the time, those medicines alleviate whatever is ailing us.  It is important that we remain vigilant and mindful about what we put into our bodies, particularly when we have some years under our belts and/or suspenders.  None of us can live a 100% risk-free, pain-free or malady-free life.  It just does not work that way, not even in Utopiaville.  Read the labels and black box warnings on any medications you are taking.  If you have questions, ask your doctor, PA or pharmacist before taking the first dose.  Then go outside and play!  Don’t worry.  Be happy.  Back in the days depicted in the old Flintstone cartoons, prescription medicines were not even an option.  We would all do well to be grateful that we have such options today.

Aaron Ainbinder is the author of “Just Before the Stroke of Seven”.


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