The Food and Drug Administration's Black Box Warning

Safety of Allergy and Asthma Medicines

Medicines with black box warnings are meant to warn doctors and patients of certain possible side effects.. Colleen Butler/E+/Getty Images

What is a Black Box Warning?

When a prescription medication is known to cause certain side effects, the Food and Drug Administration may place a warning on the prescribing information, or package insert, of the medication. These warnings range from known side effects and precautionary statements to a black box warning, the highest warning the FDA uses. A black box warning is a statement to doctors and patients that the medication has been linked to a certain severe risk or side effect, but not to the point that the medication needed to be removed from the market.

The purpose of the black box is to ensure that the prescribing doctor and patient are both aware of the risks of the medication, so that a discussion of these risks can take place.

Just because a medication has a black box warning does not mean that a person should not use the medication. In many cases, the benefits of the medication are much greater than the risks. However, many experts feel that patients should be made aware of the risks of taking a medication that has a black box warning, so that they can make an informed choice of whether or not to take the medication with input from their doctor.

Patients not only need to know what the risks are of taking a medication that has a black box warning, but also what risks there are to not using such a medication. Many chronic diseases, including asthma, have more risks from not using any medication at all when compared to side effects from typical asthma medications.

Other medication choices - and their risks - should also be discussed.

What Allergy and Asthma Medications Have Black Box Warnings?

The most common asthma and allergy medications that currently have a black box warning attached to them include Advair (fluticasone/salmeterol), Elidel (pimecrolimus) and Protopic (tacrolimus).
Xolair (omalizumab), an injectable medication used to treat asthma, was given a black box warning in July of 2007.

Should I Take a Medication with a Black Box Warning?

The answer to this question can only be made after careful discussion with your doctor regarding the benefits and risks of the medication. In many instances, particularly with the allergy and asthma medications listed above, these medications are very helpful in treating a person’s chronic symptoms, and the benefits of the medication often outweigh the risks. However, it is important for a person to understand the risks of taking the medication, other therapies that are available, as well as the risks of not taking the medication.

It is important to consider that there may be risks to not using a medication that has a black box warning as well. This is because other medications, which may need to be used instead, often have their own risks. In addition, other medications may not work as well as the black box medication, and therefore a person is at risk for complications due to their disease being under-treated.

Learn more about the specifics of each allergy and asthma medication with a black box warning:

Source: Aaronson DW. The “Black Box” Warning and Allergy Drugs. J Allergy Clin Immunol. 2006;117:40-4.

DISCLAIMER: The information contained in this site is for educational purposes only, and should not be used as a substitute for personal care by a licensed physician. Please see your physician for diagnosis and treatment of any concerning symptoms or medical condition.

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