Those Black Box Warnings

You may have been hearing about “black box warnings” lately. They have been associated with some anti-smoking medications, antidepressants, diabetes medications, certain antibiotics and…some asthma medications. Let’s clear up some of the questions you may have.

The US Food and Drug Administration (FDA) is the federal watchdog and regulating body for all prescription and nonprescription medications sold in the US. When they decide that the consumer and health professionals should be warned about potential safety risks for an approved medication, they will require that a warning be placed in a black-outlined box on the packaging, prescribing information and/or package insert. This is what is known as a black box warning.

Such a warning will state that the medicine has been linked to a serious side effect, but that it is not serious enough to take the drug off the market. It is meant to help both you and your doctor make an informed decision about using the drug.
Several long-term asthma medications have received the black box warning lately, for example: Advair Diskus, Advair HFA, Serevent Diskus, Foradil  Aerolizer and Symbicort.

However, just because a medication has a black box warning, it doesn't mean you should stop taking it.  In fact, not taking your medication could be riskier than taking it. Many people continue to take these medications without any problems. It's important to talk with your allergist, ask questions and weigh the risks versus the benefits for you.

As a team, you can decide what to do next.

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