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FDA Safety Update: Asthma Medications

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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.

Recommended Related to FDA Center

FDA's MedWatch Safety Alerts: August 2009

After the Food and Drug Administration (FDA) approves a product and it is on the market, FDA continues to monitor unexpected and undesirable side effects (adverse events) of that product. Health care professionals and consumers may report side effects, product quality problems, product use errors, or therapeutic failure with the use of medical products to FDA's MedWatch Adverse Event Reporting program either online, by regular mail, by fax, or by phone. Online at https://www.accessdata.fda...

Read the FDA's MedWatch Safety Alerts: August 2009 article > >

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: http://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm051132.html.

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.

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