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FDA Safety Update: Asthma Medications

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Suicidality and Behavior/Mood Changes with Singulair continued...

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.

FDA is working with Merck to perform a complex analysis of Singulair data and will communicate the conclusions and recommendations to the public. The agency is also reviewing postmarketing reports it has received of behavior/mood changes, suicidal thinking, and suicide in patients who have taken Singulair as well as other leukotriene modifying medications, such as Accolate (zafirlukast) and Zyflo (zileuton) and Zyflo CR.

Advice for patients …

Patients should not stop taking these medications before talking to their health care professional about this information. FDA urges patients to report side effects from use of these medications to FDA's MedWatch Adverse Event Reporting Program at: http://www.fda.gov/Safety/MedWatch/default.htm

The Early Communication About an Ongoing Safety Review of Montelukast (Singulair) may be found at: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm070618.htm.

Safety of Long-Acting Beta Agonists (LABAs)

Bronchodilators are medications that help open up the breathing tubes, but they do not treat the underlying inflammation of asthma. Short-acting bronchodilators are quick-relief medications used for treatment of asthma symptoms. One example is Albuterol. Long-acting beta2 adrenergic agonists (LABAs) are bronchodilators used to provide long-term control of asthma. Examples of medications that contain LABAs and that are approved for use in asthma patients include Advair Diskus (fluticasone propionate; salmeterol xinafoate), Symbicort (budesonide; formoterol fumarate dihydrate), Serevent Diskus (salmeterol xinafoate), and Foradil.