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FDA Safety Update: Asthma Medications

Asthma is a chronic, life-threatening disease that causes the airways to become inflamed or swollen. When people with asthma react to various triggers, such as upper respiratory infections, dust, pollen, or smoke, their airways become narrow. This can cause difficulty breathing, wheezing, chest tightness, or coughing. The two main types of asthma drugs are quick-relief medications that immediately treat sudden symptoms and long-term control medications that are taken regularly to prevent symptoms.

Here is a Food and Drug Administration (FDA) update on recent safety issues with asthma medications.

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Incorrect use of Foradil Aerolizer

In February 2008, FDA issued a Public Health Advisory to highlight the correct use of Foradil capsules. Foradil Aerolizer (formoterol fumarate inhalation powder) is approved to prevent wheezing and breathing problems caused by asthma and chronic obstructive pulmonary disease (COPD).

The medication in Foradil capsules is specifically designed to be inhaled through the Foradil Aerolizer inhalation device to deliver the medicine to the lungs. FDA and the American Association of Poison Control Center's National Poison Data System have received reports of people swallowing the capsules rather than placing them in the inhalation device.

Few patients have experienced side effects from swallowing the capsules. But the medication won't work if the capsules are swallowed rather than inhaled. FDA's Public Health Advisory on Foradil also addresses similar incorrect use of Spiriva HandiHaler (tiotropium) capsules, which is approved by FDA to treat COPD.

Advice for patients …
Patients should not swallow the Foradil or Spiriva capsules as the capsules are only to be used with the inhalation device provided with the product. Patients should follow the instructions in the patient information leaflet provided with the product.

The Public Health Advisory: Important Information on the Correct Use of Spiriva and Foradil Capsules, may be found at:

Suicidality and Behavior/Mood Changes with Singulair

Singulair (montelukast sodium) is approved to treat asthma and symptoms of allergic rhinitis (sneezing, stuffy nose, runny nose, itching of nose), and to prevent exercise-induced asthma. Singulair is part of a class of "anti-leukotriene" drugs. These drugs act by blocking the activity of leukotrienes, chemicals that are involved in airway inflammation.

In the past year, Merck & Company, Inc. has updated the patient information for Singulair to include these postmarketing adverse events: tremor, depression, suicidal thinking and behavior (including suicide), and anxiousness.

In March 2008, FDA issued an early communication about an ongoing safety review of Singulair. The agency is investigating a possible association between the use of Singulair and behavior/mood changes, suicidal thinking and behavior, and suicide.

Early communications are in keeping with FDA's commitment to inform the public about its ongoing safety reviews of drugs. An early communication does not mean that FDA has concluded that there is a causal relationship between the drug and the emerging safety issue. It means that FDA is considering the information but has not yet reached a conclusion.