Black box warnings

Black box warnings

When is the last time you actually read the label on your prescribed medication? Due to a growing number of meds prescribed with a black box warning, you should probably take notice.

So what is it? A medication labeled with a black box warning can cause serious side effects (such as a fatal, temporary or permanently disabling adverse reaction). A serious adverse reaction can be prevented, reduced in frequency, or reduced in severity by proper use of the drug. For example, a medication may be safe to use in adults, but not in children, non-birthing women but not pregnant women. So is this a new procedure for public awareness? Not really, and it still isn't all that well known. Even though the warning system serves a purpose, a relatively small population knows about it, much less knows its purpose. As of 2010, according to the NIH, there were about 350 black box warnings issued for various medications.

What Information does the FDA Require in the “Black Box”?

This FDA-mandated warning aims to provide a concise summary of the adverse side effects and risks associated with taking the medication. Understanding side effects will help you make a better informed decision. However, a major challenge today is that physicians sometimes prescribe such a medication without neither evaluating the common side effects nor evaluating the patient's overall health and history/risks.

Common examples

The most commonly prescribed meds with black box warnings include antibiotics (Cipro), diabetes (Avandia), and antidepressants (Zoloft, Lexapro, Paxil).

Regardless of these more common examples, ALWAYS review your medications prior to consumption. And even if your medication doesn't officially have a black box warning issued by the FDA, it's not to say that it does not come with serious side effects and/or risks. Doing background research always helps, and this is also why it is extremely important that your medical history be accurate!!! (especially current meds list)

Real-life example

In February 2012, friend of mine took Cipro for 2 days before his girlfriend, a pharmaceutical professional, found out and immediately had him flush his system; it was too late. In the 18 months since then, he has been permanently disabled and bound to a chair/bed. The risk? Rupturing your tendons, ultimately preventing/limiting mobility. For the first 6 months, my friend was on medical disability. In the months since, he swam in his pool daily to improve circulation while also trying a myriad of homeopathic medical procedures/treatments, and he has improved quite a bit. He is still bound to the bed during the day, with occasional movement to/from the kitchen and bathroom. Nonetheless, he's also since gone back to work full-time, working from his bed using a projector screen via his ceiling and using a dictation command software to complete his job duties. Pretty incredible stuff that puts life in perspective... and pushes my longing to improve health care all the greater.