(BPT) – 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 (FDA) requires that some medications carry a black box warning to alert patients to the potential for serious and sometimes fatal side-effects.
Teresa Tran, a specialist pharmacist in the Express Scripts Neuroscience Therapeutic Resource Center, and her team of specialist pharmacists, help answer questions about black box warnings and other medication management issues for patients facing a wide range 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 like depression and dementia,” says Tran. “Prior to starting any medication, ask your doctor or specialist pharmacist about the side effects, risks associated with the medication and the expected benefits.
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,” says Tran. “Additionally, some antipsychotics used to treat dementia-related psychosis in elderly patients can increase the risk of death.”
Tran offers some helpful tips to keep in mind regarding black box warnings and ways you can 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, in order to prevent a relapse, you should continue taking the medication. If a patient stops a medication abruptly, new or worsening side-effects may appear.
* Become informed: Black box warnings can include risks of serious adverse effects. However, these medications can be important in treating your medical condition. Understanding the risks versus the benefits is important in being an informed consumer. Remember you play an important role as part of the health care team since you are the one ultimately responsible for your health.
* Communicate your concerns: Depression and some medications may be associated with an increased risk of suicide. If you are taking medication to treat these types of conditions, make sure family members and/or caregivers recognize potential signs of an adverse event. Keep an open dialogue with your doctor or pharmacist and notify them immediately if you experience something out of the ordinary that may be a side-effect related to your medication.
* How to educate yourself: Patient medication guides are required for drugs that have a serious and significant public health concern. They are often required for products that have boxed warnings. Patients should always read the medication guide or patient information leaflet that comes with their medication. If he/she doesn’t understand the information, or has questions, this should be discussed with a doctor or specialist pharmacist. The FDA provides a comprehensive list of medication guides which can be found online.
* 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 will also allow you to monitor whether your condition is improving or getting worse.
For more information and additional ways to become a more engaged and empowered patient, visit Express Scripts’ Healthcare Insights blog at lab.express-scripts.com.