Great. Just when I thought that I figured out why I am depressed, I get this in my email box from the FDA. I’m on Singulair because of my asthma. I wonder what Philip at Furious Seasons would say.
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.
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/medwatch/report/consumer/consumer.htm
Great. Just when I thought that I figured out why I am depressed, I get this in my email box from the FDA. I’m on Singulair because of my asthma. I wonder what Philip at Furious Seasons would say.
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.
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/medwatch/report/consumer/consumer.htm
The Early Communication About an Ongoing Safety Review of Montelukast (Singulair) may be found at: www.fda.gov/cder/drug/early_comm/montelukast.htm