HealthCare

 What are some possible side effects of Singulair.  (This list is NOT a complete list of side effects reported with Singulair.  Reports of patients’ experiences after Singulair became available include: Allergic reactions including swelling of the face, lips, tongue, and/or throat, (which may cause difficulty in breathing or swallowing), hives, and itching.  Stop taking Singulair and call your doctor if you experience any of these symptoms.  Although it has not been shown to cause this condition, you must tell your doctor right away if you get one or more of these symptoms

 FDA's Suicide Investigation In early Spring 2008, the FDA announced it was investigating the asthma drug Singulair for links to depression, changes in mood and suicide.  Of the new class of asthma medicines called leukotriene blockers, Singulair is the first intended for both adults and children as young as six,and the first developed for once-daily use.  The marketing clearance of Singulair is based on clinical studies that measured efficacy and safety in more than 3,000 adults and children, aged six to 14 years.  In clinical studies, this medicine improved asthma control in many patients by significantly decreasing asthma attacks, preventing daytime and night-time asthma symptoms, and reducing reliance on other asthma medicines, such as quick-relieving bronchodilators.

 However, Singulair may not completely eliminate the need for inhaled or systemic corticosteroids.  Side effects with Singulair were usually mild and generally did not require patients to stop taking it.  Side effects seen in adults and children during the clinical trials were similar for the groups treated with Singulair and for those treated with placebo.  The most commonly reported side effects in adults for both placebo and Singulair were headache, influenza and abdominal pain. 

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 Food and Drug Administration (FDA) recently announced that it is investigating a possible link between the use of the asthma and allergy medication Singulair (montelukast) and behavior or mood changes, including suicidal thinking and action.  The investigation is based upon a small number of reported suicides among millions of people who have taken this medicine.  None of the more than 40 studies of Singulair involving more than 11,000 adults and children have reported a link between Singulair and suidical thoughts or actions.  Until then, no one can be sure if there is any link between this medicine and suicide.  In the meantime, physicians at National Jewish recommend that patients taking Singulair, and the related medications Accolate, Zyflo, and Zyflo CR, should continue taking those medications as long as they are effective and the patient does not experience any suicidal behavior or thoughts.

Merck the maker of singulair says  "We have no indication that anything about the mechanism of Singulair is consistent with these events," said George Philip, director of research and product development.  Merck said it recently added reports of suicide to Singulair's label, which already listed suicidal thinking and behavior as reported side effects.  "Patients should not stop taking this medicine before talking to their doctor," FDA said in its statement, adding that doctors should monitor patients for suicidal behavior and mood changes. 

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