What Is a Black Box Warning?

Question: What Is a Black Box Warning?


A black box warning or a 'boxed warning,' using FDA terminology, is used to deliver need-to-know information to you and your doctor about a particular drug. A black box warning helps ensure that drug labeling is clear, consistent and provides essential information health care providers need to know when prescribing a medication for you.

If an asthma drug has a black box warning, that doesn't mean that it is unsafe or should be taken off the market.

Rather, it means that you and your asthma doctor need to have a discussion about the risks and benefits of taking the drug, and whether or not a particular drug is appropriate for you.

FDA drug labeling has a number of safety sections including:

Warnings and Precautions: Adverse reactions or side effects are included in this section if they are felt to be clinically significant and have either occurred with use of a drug or are expected to occur. So for example, you will find irritability listed as a side effect in this section labeling for albuterol. You will also find hypertension or elevated blood pressure listed as a precaution because the drug is expected to raise blood pressure in patients and has occasionally done so to dangerous levels for some. It does not mean that this will happen to you, but it does mean you and your provider need to be mindful of the possibility.

Contraindications: Clinical conditions where the risks of taking a drug clearly outweigh the benefits get mentioned here.

With albuterol, this would include a warning on the label for patients who have had some sort of allergic reaction related to albuterol.

Boxed Warning: A black box waring may be included in the drug labeling when:

  • A side effect is so serious (e.g. death or disability) that your doctor must consider that side effect when prescribing the drug.
  • Side effects can be diminished by carefully identifying if you will benefit from use of the drug or not.
  • The FDA feels a drug should be limited to certain patients based on age or some other characteristic like pregnancy.
  • A particular drug is somehow different from other drugs in its class. For example, if there were some major difference between Advair and Symbicort-- both combination inhalers with inhaled steroids and a LABA.

All of the following asthma medications have some sort of black box warning:

  • Xolair
  • Advair
  • Serevent Diskus
  • Foradil Aerolizer
  • Symbicort


FDA Guidance For Industry. Accessed May 31, 2010. Adverse Reactions Section of Labeling for Human Prescription Drug and Biological Products

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