FDA: New Warnings for Three Asthma Drugs

The FDA is alerting asthma patients and their doctors that three long-acting inhaled asthma medicines “may increase the chance of severe asthma episodes, and death when those episodes occur.”

That quote comes from an FDA public health advisory on the three products -- Advair Diskus, Foradil Aerolizer, and Serevent Diskus. The drugs are long-acting beta-agonists, or “LABAs,” which help relax the muscles around the lung’s airways.

“Even though LABAs decrease the frequency of asthma episodes, these medicines may make asthma episodes more severe when they occur, says the FDA.

The FDA has ordered the manufacturers to update the products’ labels about the risk. In July, an FDA panel recommended that all three drugs remain available.

In 2003, Advair and Serevent got “black box” warnings about the risk. Advair and Serevent have the same active ingredient (salmeterol). Foradil has a different active ingredient but is in the same class of drugs.

FDA’s Recommendations

The FDA’s public health advisory highlights recommendations about using LABA medicines for asthma:

--LABAs shouldn’t be the first medicine used to treat asthma. They should be added to the asthma treatment plan only if other medicines do not control asthma, including the use of low- or medium-dose corticosteroids.

--Don’t stop using your LABA or other prescribed asthma medicines unless you have discussed it with your doctor.

--Don’t use your LABA to treat wheezing that is getting worse. Call your doctor right away if wheezing worsens while using an LABA.

--Always have a short-acting bronchodilator medicine (such as Proventil inhaler) with you to treat sudden wheezing. LABAs do not relieve sudden wheezing.

Updated Labels

The FDA’s proposed changes to the products’ labels explain that even though LABAs decrease the number of asthma episodes, the medicines may increase the chances of a severe asthma episode when they do occur.

In one asthma medicine study, an increased number of people taking an LABA in addition to their usual asthma care died from their asthma compared with people taking a placebo in addition to their usual asthma care. However, the number of asthma deaths in that study was small, says the FDA.

The new warnings are about LABA use for asthma. It’s not clear if there are similar concerns when LABAs are used for exercise-induced wheezing (bronchospasm) or chronic obstructive pulmonary disease (COPD), says the FDA.

Serevent and Advair are made by GlaxoSmithKline, a WebMD sponsor. Foradil is made by Novartis and marketed in the U.S. by Schering-Plough.

By Miranda Hitti, reviewed by Louise Chang, MD

SOURCES: Public Health Advisory, FDA. WebMD Medical News: “FDA Panel: 3 Asthma Drugs Can Stay.”