The FDA’s Black Box Warning: What You Need to Know

The FDA’s Black Box Warning: What You Need to Know

It is critical that drug companies include informative warning labels concerning the potential side effects of a drug. However, sometimes companies fail to create a comprehensive warning label, or severe health risks linked to a drug are not apparent until after it is on the market. In these cases, the FDA steps in to require a black box warning also referred to as a boxed warning. Currently, over 400 drugs have a black box warning. In fact, you might even have a black box warning on your current medication. Keep reading to understand black box warnings and how they may affect you. 

The FDA’s Highest Safety-Related Warning

The FDA issues a black box warning for drugs that carry a risk of significant health effects such as injury or death. Introduced by the agency in 1979, black box warnings outline the most serious concerns tied to the drug. Sometimes a black box warning conveys important instructions for the drug, like “do not drink alcoholic beverages when taking this medication.” These warnings alert healthcare providers and patients about hazardous and life-threatening health complications associated with a particular drug. Therefore, before prescribing a medication, the doctor can discuss the potential benefits against the possible side effects. With this information, doctors and patients can choose to explore alternative options if the risks are too high or severe. 

How Does a Drug Receive a Black Box Warning?

The FDA determines the necessity of a black box warning after reviewing evidence that reveals the drug poses a serious health risk. Usually, this evidence stems from clinical trials or adverse health reports submitted to the agency by physicians or patients. Yet, the FDA will typically not obtain this vital information until the drug has already been on the market for some time. While the FDA does require clinical data before granting approval, more health hazards present themselves once a wider population takes a drug. Reports through the agency’s MedWatch feature illuminate previously unconsidered or undetected side effects of a drug. Due to this, many newly available drugs will not have a black box warning. 

As the FDA analyzes reports detailing the safety issues of a drug, it will consider the following before applying a black box warning: 

  • If the drug presents a considerable detrimental risk to the health of patients
  • Whether appropriate usage of the drug reduces or avoids certain side effects – not mixing other medications or not drinking while on the drug 
  • If the drug needs restrictions to ensure its safety – specific populations should not take the drug like pregnant people or the elderly 

Drugs With Black Box Warnings

Numerous drugs have black box warnings of varying degrees. Although the FDA does test and inspect drugs beforehand, the agency’s stamp of approval is not a 100% guarantee. A few examples of drugs with the FDA’s black box warning include: 

  • Truvada received a black box warning in 2019, fourteen years after its approval. The warning describes the risk of hepatitis B, renal impairment, and a decrease in bone mineral density.
  • Beovu now has a black box warning to inform patients about the possibility of blindness and other vision damage related to the drug.
  • Uloric’s black box warning describes the heightened risk of cardiovascular events linked to the drug
  • In 2019, the FDA announced Ambien will have a black box warning regarding the risk of injury or death while sleepwalking.

FDA Approval and Black Box Warnings

In 2017, the Journal of the American Medical Association revealed that between 2001 and 2010, the FDA added 61 black box warnings. The JAMA study showed that the FDA approved 222 drugs in nine years, yet nearly a third eventually required black box warnings. Furthermore, drugs granted fast-track status were 3.5 times more likely to gain a black box warning. 

Additionally, a study in 2017 discovered that of the 219 drugs approved between 1997 and 2009, 30 received black box warnings by 2016. Overall, many consider black box warnings as effective warnings. However, critics argue that the FDA should implement more stringent precautions to safeguard the public from dangerous drugs.