Published on:

Understanding Black Box Warnings on Drugs

The term “black box warning” is used to describe the warning labels we often find on our prescripBlack box warnings drugstion medications. It is derived from the black border that is often found around the most severe warnings. These warnings can produce crucial information and keep us aware of any risks and adjustments we need to make when taking certain medications. Many people feel that they are not being used effectively, however, and that drug companies are deliberately concealing much of the information that belongs in these warnings.

Explosion of Black Box Warnings over the Last Decade Cause for Concern

The information gleaned from clinical trials prior to drug approval is used to determine how safe medications are and if any warnings are required, but there are often side effects and adverse reactions with other medications that are discovered at later times. When the FDA determines that the public requires warnings that are not currently provided, pharmaceutical companies may be required to amend their warnings and instruction sheets. A black box warning is reserved for medications with severe complications and is the last measure the FDA will use prior to having a drug removed from the market.

Consumers have seen warnings on medications for their entire lives, but the use of black box warnings has grown exponentially in just the last ten years. There is much speculation over the cause behind such a dramatic increase in warnings, but it is likely due to a rapid increase in the number of medications receiving approval and the increased ease with which these drugs can make it to market. The unfortunate effect of allowing so many medicines to be introduced without enough conclusive research regarding their safety is that patients will experience adverse effects that were not anticipated.

Black Box Warnings a Significant Portion of Amendments to Labeling

From 2005 to 2008, it was found that black box warnings accounted for over 14% of the changes made to labeling due to FDA intervention. The warnings have been added to both older and new medications as the potential for debilitating or deadly complications have been discovered. An example would be the warning issued for the contraceptive, Yaz, due to the discovery of an increased risk of heart disease among smokers. The medicine Victoza, which is used in the treatment of Type 2 Diabetes, received a black box warning when a link was established between its use and the development of thyroid cancer.

The problem is that black box warnings are not being used very effectively and many patients are still not aware of all of the risks they face when taking certain medications. Some consumers choose not to read the instructions or warnings that are provided if they are taking multiple medications. The warnings are unable to provide adequate protection for these people and they remain at risk of serious injury if they do not take their medications in the manner intended.

The increasing ubiquity of the warnings is also a problem because it increases the likelihood that they will not be taken as seriously. There either needs to be more stringent approval requirements or the FDA needs to be more proactive in taking dangerous medications off of the market before they can harm people. Unfortunately, the FDA is stretched far too thin for the implementation of either of these solutions at the moment.

How to Reduce Your Risk of Adverse Reactions

It is important that you carefully read the instructions provided with any new medication you are prescribed and understand the way it works. Taking the time to read the warnings provided will help you identify symptoms of adverse effects sooner so that you can seek medical attention before it is too late. Having a discussion with your pharmacist or doctor about possible drug interactions and any needed dietary changes will also reduce your risk.

Posted in:
Published on:
Updated:

Comments are closed.