While clinical trials help ensure medications are safe, adverse effects will remain. In fact, there are many instances where drugs make it to market despite those risks, which may lead to a “black box warning.”
Such alerts inform practitioners of serious side effects associated with the medication. Below, explore the ins and outs of black box drug warnings and tips for prescribing those medications safely.
What Is a Black Box Drug Warning?
Many prescription medications carry what’s known as a black box warning, also called a boxed warning. They are required by the Food and Drug Administration (FDA) for drugs that may cause serious or life-threatening side effects.
While these alerts are the highest caution label the FDA requires, it doesn’t mean the medicine shouldn’t be used. Rather, they highlight information doctors should be aware of regarding patient care.
Black box warnings are typically found on:
- Drug inserts
- The FDA website
- The Physician’s Desk Reference
- The drug marketing company’s website
Physicians may not always be aware of such warnings, which can change over time. Staying up to date on the latest information available about these medications can reduce this concern.
What Causes a Medication to Require a Black Box Label?
Black box warnings are necessary when a drug could potentially cause a patient severe harm, hospitalization, or even death. Generally, medications require boxed warnings for one of these reasons:
- The potential for adverse reactions outweighs the benefits of the medication
- The risk of serious adverse reactions may be prevented or reduced by appropriate prescribing efforts
- The drug has mandatory restrictions regarding who is allowed to take it, how it can be given, etc.
Examples of issues that could lead to a boxed warning include increased cancer risk, suicidal thoughts, and asthma attacks.
Keep in mind that entire drug classes may carry these alerts, regardless of the individual medication’s effects. Common examples include antidepressants, ACE inhibitors, and opioid painkillers.
Challenges of Black Box Prescriptions
Although black box labels help keep patients safe, they are not without their difficulties. For instance, there is currently no way for the FDA to report boxed warnings to physicians.
That means many doctors learn about new alerts through the media, continuing medical education (CME), or their employers. However, this information is easy to miss amid crowded inboxes and busy schedules, putting patient safety at risk.
As a result, providers should develop strategies to stay up to date on the latest box labels and safe prescribing practices.
Safely Prescribing Drugs With Black Box Warnings
In many instances, medications with boxed warnings may be the best option for your patient. Although there’s no single solution for the safe prescription of drugs with black box labels, there are strategies you can use to help:
- Review warnings with patients: Before prescribing a medication with a boxed warning, discuss the alert, benefits, and alternative options with the patient. You may provide an FDA-approved medication guide to help educate them about the drug’s risks.
- Conduct periodic reviews: Schedule time to review warnings on the medications you most frequently prescribe. Try using prescription renewal requests to ensure patients are safe to continue using the drug.
- Set up alerts: You or your office staff can subscribe to newsletters that announce box label changes and FDA alerts. Note which changes may require a patient-provider conversation.
- Document the rationale for prescribing: In the patient’s record, explain your rationale for prescribing medications with boxed warnings.
Much of this is covered in the STEPS approach, another method for determining if a black box prescription is appropriate. Here’s how it works:
- Safety: Consider the risk of long-term, serious side effects compared with alternative options.
- Tolerability: Think about the less serious side effects that may still affect the person during use.
- Effectiveness: Compare the effectiveness of this particular drug to similar ones that could be used in its place.
- Price: Consider costs that may arise should the medication require patient monitoring during treatment.
- Simplicity: Consider the medication’s ease of use, including the route of administration, dosing frequency, potential interactions, and patient monitoring.
As the provider, it’s your responsibility to know how to prescribe such drugs safely. Keep these strategies in mind to help ensure you write prescriptions appropriately.
Learn More About Black Box Drugs With CME
CME is one way to stay up to date on the latest industry developments, medication warnings, and treatment options. Refresh your memory on safe drug prescribing methods, among a variety of other topics, with one of our upcoming CME conferences!
