The Black Box That Could Save Your Life

Dec 17, 2013
The FDA requires that some medications carry a black box warning to alert patients of the potential for serious and sometimes fatal side effects.

Black boxes in airplanes or trains hold critical information relevant to a disaster. However, there is another type of black box that can help stop a medication-related catastrophe before it happens: a black box warning.

The Food and Drug Administration requires that some medications carry a black box warning to alert patients of the potential for serious and sometimes fatal side effects.

The Value of Clinical Specialization

As a specialist pharmacist in the Express Scripts Neuroscience Therapeutic Resource Center, my team and I answer questions about black box warnings and other medication management issues for patients facing a specific set of diseases, such as depression, pain, Alzheimer’s and attention deficit disorder.

Sometimes it’s hard to distinguish worsening disease symptoms from potential side effects, especially for disorders such as depression and dementia. Prior to starting any medication, ask your doctor or specialist pharmacist about side effects, risks and expected benefits associated with your medication.

Understanding Your Medication

More than 500 medications currently include black box warnings, which is the most serious medication warning required by the FDA. The list includes commonly used antibiotics, antidepressants and diabetes medications with potentially life-threatening or debilitating side effects.

Antidepressants have a black box warning because of increased risk of suicidal thinking among children, adolescents and young adults, so it’s important to pay close attention to behavioral changes, especially during the first one to two months of treatment. Additionally, some antipsychotics used to treat dementia-related psychosis in elderly patients can increase the risk of death.

Tips to Achieve Healthier Outcomes

Follow Doctor’s Orders: Listen to your doctor’s instructions on the duration and course of your medication therapy. Even if your symptoms are completely resolved, you should continue taking the medication to prevent a relapse. If a patient stops a medication abruptly, new or worsening side effects may appear.

Communicate Your Concerns: Depression and some medications may be associated with increased risk of suicide. If you are taking medication to treat these types of conditions, make sure family members and caregivers recognize potential signs of an adverse event. Keep an open dialogue with your doctor or pharmacist and notify him immediately if you experience something out of the ordinary that may be a side effect related to your medication.

Educate Yourself: Patient medication guides are required for drugs that have a serious and significant public health concern. You should always read the medication guide or patient information leaflet that comes with your medication. If you don’t understand the information or have questions, discuss with a doctor or specialist pharmacist. The FDA provides a comprehensive online list of medication guides.

Keep a Journal: For conditions that don’t have concrete ways to measure success, like depression, maintaining a daily journal to track your symptoms will allow you and your doctor to chart your progress and adjust your medication therapy. Keeping track of your baseline symptoms prior to starting a medication also will allow you to monitor whether your condition is improving or getting worse.

Becoming an engaged patient can help lead to better health outcomes. For questions, contact your doctor or specialist pharmacist.

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