Black Box Warnings-Be Aware

“Black box” warnings are issued by the FDA when a drug causes life-threatening complications.

The FDA uses this warning when it’s necessary to “call attention to serious or life-threatening risks.” To a layman, it means these drugs are potentially the most harmful of all drugs issued.

Most drugs are slapped with black box warnings after they are already on the market. There are black box warnings on drugs as common as Xanax and Adderall. These are pills prescribed to millions of Americans every year. And the warnings aren’t innocuous. The black box warning for Adderall, for example, states “increased risk of sudden death and cardiovascular events”.

The risks for black box drugs that aren’t as common can be even more extreme. An anticoagulant drug called Xarelto has been tied to severe internal bleeding incidents, and it doesn’t have an antidote! This means that if an unfortunate patient has an internal bleeding incident while taking the drug (even as prescribed), they will likely bleed to death because there is no counter-drug to reverse the effects.

Whether you’re taking a black box drug or not, you probably want to know the best ways to stay safe from such harmful side effects.

The best way, even though it’s a cliché, is to become your own doctor and advocate. Most doctors in the U.S. have very limited time with each patient, which logically infers that they’re less likely to do extensive research on each individual patient’s needs and issues. You should read through all the documentation that comes with prescriptions you’re written, and come with a list of succinct questions to ask your doctor or pharmacist when you have an appointment. It’s also a good idea to do your own research using free resources like PubMed where you can search clinical trials by condition or by treatment.

If, unfortunately, you do have an adverse reaction from the drug (which is possible even when being fully prepared beforehand), make sure to report it on the FDA Medwatch site. This will help the organization determine whether the drug is still safe for consumers. You also have the option of calling the FDA directly at 1-800-FDA-1088 to report the incident.

There is also the option to stay away entirely from black box drugs as much as possible through diet, exercise and lifestyle changes, and given the risks discussed in this article, that may be the prudent thing to aim for.