What You Need to Know About Asthma Drug Black Box Warnings

Health Professional

Black box warnings are a type of labeling that the Federal Drug Administration (FDA, for short) requires pharmaceutical companies to use when a drug has possible side effects that are dangerous, rather than just annoying. In the past couple of years, several asthma medications have received black box warnings and now there are more.

The first asthma medicines to require black box warnings were in a class of medicines called long-acting beta agonists, or LABA for short. This type of medication helps your airways to relax, but doesn't do anything to treat the inflammation that is at the root of asthma. LABAs have some usefulness in treating asthma, but are not sufficient to control asthma symptoms on their own.

The type of asthma medication that most experts recommend initially is an inhaled steroid. However, LABAs are sometimes used to supplement the steroids. The LABAs that received black box warnings some time ago were Serevent (salmeterol) and Foradil (formoterol), along with two combination medications that combine them with a steroid: Advair & Symbicort. Xolair, an injectable asthma medication, was added into the black box list, as well.

Recently, the FDA also began to require black box warnings for another class of asthma medications, called leukotriene modifiers or blockers. Leukotrienes are natural proteins in the body that are part of the immune process that causes asthma symptoms. Leukotriene blockers interfere with that process. Unfortunately, there have been a number of reports that these medications can cause behavior and/or mood changes.

The medications involved and getting new black box warnings include:

Singulair is used to treat both asthma and nasal allergies. The other three medications treat only asthma. You may remember hearing a year or so ago that Singulair had been linked to an increased risk for suicide. A review by the FDA at the time concluded that there was no definite link. But apparently, further study has revealed some concerns about milder neuropsychiatric effects, such as:

  • agitation
  • aggression
  • anxiousness
  • dream abnormalities and hallucinations
  • depression
  • insomnia
  • irritability
  • restlessness
  • tremor

So, if you're taking one of the leukotriene blockers listed above and you notice any of these symptoms (or if you do feel yourself starting to think about suicide), be sure to call your doctor right away to discuss the pros and cons of continuing on the medication. Don't just stop taking it on your own without getting input from your doctor first

Although it is likely that your doctor will take you off the medication, you'll want to start taking an alternative at the same time, to make sure your asthma stays under control.