Adverse Drug Events: What Consumers Need to Know

In 2019, pharmacies filled an estimated 4.38 billion prescriptions.

When you pick up your medication, it comes with a paper or booklet containing pertinent information about that specific medicine. Do you discard those papers or do you read the fine print?

I’ll be honest; I never used to think twice about them and often tossed them aside.

Take it from me, though — it’s important to take the time to read and understand that information because what you don’t know can hurt you.

Fifteen years ago, I was medically harmed after taking a fluoroquinolone antibiotic called Levaquin. My doctor prescribed it for a suspected sinus infection. Less than a month later, I suffered my first adverse reaction. My Achilles tendon in my right foot ruptured. Over the next decade and a half, I had over 30 ruptures.

In addition to the tendon ruptures, I was also dealing with peripheral and central nervous system damage, muscle and bone pain, dizziness, vision problems, brain fog and too many other adverse reactions to list here.

Adverse Drug Events vs Side Effects

It is important to distinguish between adverse drug events and side effects.

An adverse drug event (ADE) is an injury resulting from medical intervention related to a drug. This can include medication errors, adverse drug reactions, allergic reactions, and overdoses. ADEs can happen anywhere: in hospitals, long-term care settings and outpatient settings. An adverse drug reaction, also known as a side effect, is a documented therapeutic effect that occurs when treatment goes beyond the desired effect, or a problem occurs in addition to the desired therapeutic effect. Side effects are studied during clinical trials and drug development in order to weigh the benefits of the medication versus the risks.

Mild examples of a side effect could include dry mouth or drowsiness. However, some medications, either as a result of an error or taken correctly as prescribed can also produce significant life-altering or permanent consequences.

In its most recent awareness campaign about adverse drug events, The American Society of Pharmacovigilance designated March 24 annually as National Adverse Drug Event Awareness Day. As a Communications Team Lead for the organization, I am passionate about empowering patients to share their adverse drug event stories and creating opportunities for their voices to be heard.

It is important for both patients and medical professionals to have all the available information to make an informed decision about the risk vs the benefit of a medication.

What Can You Do?

Always report adverse events to Medwatch, the Food and Drug Administration’s Safety Information and Adverse Event Reporting Program. You can report online, by phone or by mail. Statistically, less than ten percent of adverse reactions are reported to the FDA.

The reason for this can be one of the following:

• Patients don’t know their adverse event is related to medication.
• Patients don’t know they even have the ability to report an adverse event.
• Reporting is not mandatory for physicians or consumers, leading patients to believe an adverse event is par for the course.

The low reporting of adverse events makes it difficult to know how widespread this problem is. To bring this important issue to the forefront, the American Society of Pharmacovigilance launched the Fourth Cause Campaign, which encourages patients to share their stories and urges health care professionals and organizations to discuss the work they do to champion medication safety.

A goal of the campaign is to highlight the importance of reporting events. The FDA uses the Medwatch system to monitor safety and efficacy. Should reports come in about adverse events, the FDA will evaluate them and hold an advisory hearing to discuss possible labeling changes or the addition of Black Box Warnings, the strictest warning set forth by the FDA.

Through my patient safety journey from harmed patient in 2006 to my work at the FDA presently, I’ve learned a lot about adverse events, including this: what you don’t know can hurt you. This is why I speak up about what I went through. The infection I mentioned earlier? It turned out that it wasn’t an infection after all and the cure for it was worse than the condition I had. For the rest of my life, I will carry the adverse events and consequences of taking a certain medication because I didn’t know any of this beforehand. It’s a heavy burden to carry.

Today, there are seven Black Box Warnings on the antibiotic I took. These changes were made possible because so many of us shared what happened to us and because we don’t want the same to happen to others. Using your voice can be powerful in making healthcare safer.

Help us raise awareness about adverse events by sharing your story using the #fourthcause hashtag.