What Is An FDA Black Box Warning And Why Must We All Learn The Answer?

What is a black box warning?

Are you familiar with the therm “black box warning?’ If not, you may be thinking it has something to do with airplane black boxes, the ubiquitous indestructible flight recorders found on every plane, and the data provided to investigators after a tragedy. Now, cars are even fitted with black boxes by insurance companies, which monitor and assess a driver’s habits and driving style, which is then used to determine the driver’s insurance premiums, and so maybe the warnings are notices provided to drivers to start driving slower or more carefully.

Black Box Flight Recorder. Image Credit: Wikipedia Flight Recorder Entry License by CC 2.0

Black Box Flight Recorder. Image Credit: Wikipedia Flight Recorder Entry License by CC 2.0

But that’s not it at all. Black box warnings are something else entirely, and only share a name with those other sorts of black boxes most of us are familiar with. In fact, black box warnings are such a dreadfully serious matter that each and every American citizen should know the answer as to what they are, and be well familiar with why black box warnings are no laughing matter. Sadly, however, most people I’ve spoken with have never heard the term used in the manner in which I will describe below, though it’s far more important to know about than airplane or car black boxes ever will be.

Uloric Black Box Warning

Uloric Black Box Warning

Actually, Black Box Warnings, or simply Boxed Warnings, are notices placed on the inserts of some prescription drugs in the United States by the Food and Drug Administration, or FDA. The name comes from the fact that such warnings are literally text within a black border, or box. A black box warning is a serious matter; it means that the FDA has determined, through medical studies, or adverse reaction reporting, or both, that a prescription drug carries well-defined risk of significant or deadly adverse effects. A black box warning can be for an individual drug or an entire class of drugs. Some drugs actually come to market with a black box warning already included as part of the product description, if pre-market data indicates it’s necessary.

FDA Logo

FDA Logo

There are no black box warning for OTC (over the counter) drugs, medical procedures and surgeries, specific medical modalities such as chiropractic care, therapeutic massage, acupuncture, or even non-surgery medical devices like orthotics shoe inserts, eyeglasses, or hearing aids. A black box warning may only be found in a prescription drug’s insert literature, the folded up little notice slightly thicker than tissue paper with nearly-microscopic writing patients usually throw away when opening prescription medicine they picked up at the pharmacy. The black box warning may also appear on a prescription drug pill bottle label.

How do these warnings help patients?

While generally safe and effective, some prescription drugs are not without their side effects. These negative experiences associated with use of a drug range from mild to severe; the more hazardous potentially causing disability, birth defects in offspring, or even death of the patient. Black box warnings are only used when the potential adverse effects of a prescription drug may be severe enough to fall into one of these three categories.

The FDA Adverse Event Reporting System, or FAERS, is a database used by medical professionals to log post-market adverse side effects for drugs. This system was only available to physicians, however, it’s been made public, and patients may now search its results on their own. The issue with this system is that it’s under-utilized; there may be a widespread issue of medical professionals under-reporting, or failing to recognize, adverse effects. These adverse events are logged for all proscription drugs, not only those with boxed warnings, however, such side effects are initially identified through the FAERS system.

Use of this system is voluntary, and doctors, nurses, physician assistants, nurse practitioners, pharmacists, drug manufacturers and consumers can all submit reports. If you have experienced an adverse reaction to any pharmaceutical drug, you may submit a report by clicking on this link: https://www.fda.gov/about-fda/medical-product-safety-information/medwatch-forms-fda-safety-reporting

In 1979, black box warning were first introduced to the American medical scene. Black box warnings are regarded as advisories for patients, doctors, and pharmacists, and were never intended to be interpreted as absolute contraindications, but rather as serious considerations when prescribing. So, a doctor might prescribe a drug with a black box warning to an at-risk population, if they feel that the benefits outweigh the risks. Of course, patients should be proactive, and can request an alternative.

Without reading through the literature included in the package, or noting the warning on the pill bottle, patients may not be aware of the risk to their safety. Oftentimes, doctors do not sufficiently explain risks to patients; while informed consent is one oft he cornerstones of modern medicine, this lack of communication between doctor and patient persists and is widespread. Therefore, do not expect your caregiver to sufficiently explain black box warnings, or even notify you of their placement on a drug they prescribe.

black box warning

black box warning

What are some examples of a boxed warning?

It’s really not so difficult to find examples. This article should only serve as a basic starting point for your own investigation. Therefore, only three examples are included, though far many more might be found within a few minutes of searching on Google. Such a search might be a good idea; knowing which drugs might present serious issues to consumers is probably knowledge in a class all its own, more relevant and important than most of what we spend our days learning.

Fluoroquinolones antibiotics, widely prescribed in our modern era, include pharmaceuticals such as ciprofloxacin, brand name Cipro®, and levofloxacin, branded as Levaquin®, and others usually ending with the suffix xacin. Believe it or not, these drugs, while effective at fighting some bacteria, may also increase the risk of tendinitis and tendon rupture. And that warning applies to patients of all ages, not just the elderly. In the event of tendon rupture, quite often the only solution is surgery. Pain, swelling, or inflammation may precede rupture, and are valid reasons for a patient to discontinue use of such drugs. There are also other black box warnings for this same class of drugs; research on your own to discover what they are.

Another black box warning all Americans should know about regards antidepressants and the risk these drugs present in raising rates of suicide risk among children, adolescents, and young adults under the age of 24. Use of antidepressants nearly doubles the risk of suicide among patients within these age groups. While controversial because some medical professionals feel this might keep necessary drugs from patients who might benefit, the FDA determined that the warning was indeed necessary. Just because a doctor feels the risk is acceptable for a patient does not mean that the patient, or caregiver, will necessarily agree.

A third example of a black box warning concerns “birth control” pills to prevent conception in women of childbearing age. Combination oral contraceptives for women which combine estrogen and progestin, such as Alesse®, Yaz®, Zarah®, Ocella®, and others, should never be used by women who smoke tobacco products. The packaging black box warning indicates that women over 35 should not use these products if they smoke, as there is an increased risk of serious cardiovascular side effects. Women who are older, smoke more cigarettes each day, or both, are at an even higher risk. Like all the other black box warnings, this is essential to know.

If a loved one is prescribed a drug with a black box warning, what can I do?

If you are responsible for another family member’s medical care because they are under-age and you’re their legal guardian, via power of attorney, or you’re a legal health care proxy, ultimately, you can make the decision for a prescriber to find an alternative drug. However, if you do not fall into any of these classes, all that you are legally permitted to do is make suggestions and inform your loved one of the risks. Ultimately, it’s their choice, in these instances. If you are prescribed a drug with a black box warning, you have the legal right to ask questions, or request that an alternative be provided by your prescribing medical professional. It’s OK to challenge such recommendations for drug prescriptions; don’t worry about being “noncompliant.” It may just save your life or the life of someone you love, or prevent lifelong disability.

According to the website drugwatch.com, there have been 61 black box warnings for drugs approved in the time span between 2001 and 2010. It’s your right, as a patient, to know about these hazards that certain pharmaceutical drugs may present to you, or those whose health care you are entrusted to protect, such as your children, or those you’ve been legally tasked with protecting, such as an aging parent or relative with cognitive issues. Read the literature. Search online. Use the FAERS database. Although you haven’t been to medical school, as long as you are able to read, you should do so. And then, write down your list of pertinent questions and be sure to ask them.

If the answers you receive remain unsatisfactory, refuse the drug and ask for another. It’s within your rights to do so, and exercising your will in this instance is nothing short of necessary. If your prescribing medical professional will not comply, scoffs at your request, or otherwise fails to recognize your rights to say no to a potentially hazardous drug, it’s definitely time to shop for a suitable replacement caregiver. Don’t be shamed into conceding; it may be a matter of life and death. In hospital or hospice settings, where that may not be possible, try your best to work with the prescriber to arrive at a solution that works best for you or your loved one, even if it takes ample persistence. As Americans, we do have medical rights, but without exercising such rights, we lose them by default.

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