Understanding Black Box Warnings for Asthma Medicines

Health Professional

Some of the most effective asthma medicines are inhaled steroids, and the downside to this is that the word "steroid" has a bad reputation. But what many people don't understand is that the steroids that have caused that negative publicity are NOT the kind of steroids that asthma sufferers take.

In fact, the steroids that people are fearful of are called anabolic steroids, artificial substances used by some bodybuilders and athletes to build bigger muscles and enhance athletic performance. This type of steroids bears no resemblance to the inhaled steroids you may be taking. Inhaled steroids are actually very similar to natural substances in your own body.

Although all medicines can cause side effects, the inhaled steroids used for asthma have proven to be very safe. Most side effects, if they do occur, lessen or even disappear over time. And the benefits greatly outweigh any risks, at any rate.

However, other long-term asthma medications that are sometimes used in lieu of or in addition to inhaled steroids recently received black box warnings from the FDA.

So, what do these black box warnings mean to people suffering from asthma?

First, let's define "black box warning." 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 the doctor and the patient make an informed decision about using the drug.

Several long-term asthma medications have received the black box warning lately:

  • Advair Diskus
  • Advair HFA
  • Serevent Diskus
  • Foradil Aerolizer
  • Symbicort

If you take one of these medications, you're probably wondering, "Oh my gosh... should I be concerned? Or stop taking my medicine?"

Not so fast... let's take a closer look at what a black box warning really means in this case.

According to Johns Hopkins Health Alerts newsletter, the black box warnings came out of a long-term study done with asthma patients, the SMART study (for the Salmeterol Multi-center Asthma Research Trial). The SMART research compared the safety of salmeterol to placebo. (Salmeterol is a long-acting bronchodilator type drug and is the active ingredient in both Advair and Serevent.)

They found that there were more asthma-related deaths among the people using salmeterol vs. those using placebo.

On top of those results, an analysis of 19 other studies by the _Annals of Internal Medicine _ revealed that long-acting bronchodilators greatly increased the risk of hospitalization, life-threatening exacerbations, and death. In fact, experts estimated that salmeterol was responsible for 4000 out of 5000 total asthma-related deaths each year in the US.

Pretty scary, huh? I used to take Serevent for years sure am glad I'm still alive The bottom line is lots of people stopped taking Advair, Serevent, etc. after the black box warnings were issued.

But is that necessary? Should these drugs be taken off the market?

The answer is "probably not." It comes down to analyzing the risk vs. benefit. It's also important to realize that the number of deaths in the studies may have been what is considered "statistically significant", but that doesn't mean the numbers were large. In other words, the risk is large; the numbers not so much.

If you are taking one of these medicines (or one is prescribed), it's important to talk with your doctor. Every treatment decision should be based on individual factors. People who have severe persistent asthma, in particular, often do very well on one of these medicines, especially when used in conjunction with an inhaled steroid.

Inhaled steroids will always be the drug of choice for asthmatics starting out. They are effective, relatively safe, and easy to use. But they won't bring asthma under control in every single instance. In those cases, doctors will look to expand the treatment plan, possibly to include a long-acting bronchodilator.

If you are taking an long-acting bronchodilator like Advair, Serevent, Foradil or Symbicort, it's important to know that if your wheezing worsens and/or won't go away, you MUST let your doctor know right away. It could be a sign that you need a change in medication.