Singulair : Merck has added information about Singulair side effects

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Within the past year, Merck has added indications to the prescribing information about Singulair side effects which indicate that the drug could be associated with tremors, depression, suicidal thinking and anxiousness.  The agency will review available information to look for reports of behavior and mood changes, suicidal thoughts and suicides among Singulair users.  As part of their review, the FDA will evaluate whether any suicide risk with Singulair may also be associated with Accolate, Zyflo and Zyflo CR.  However, those medications have been taken by a very small number of people when compared to those who have been prescribed Singulair

While the FDA continues their investigation of the Singulair suicide side effects, they have cautioned doctors to carefully monitor patients taking the drug for mood changes and signs of suicidal thoughts.  The FDA has indicated that the early communication does not mean that there is definitely a relationship between Singulair side effects and suicides, but reports received have led the agency to take a closer look at this emerging safety issue.  are closely monitoring the FDA’s investigation into the possible Singulair suicide side effects.  If you, a friend or family member have suffered severe physical injury or death as a result of a suicide or suicide attempt while taking Singulair, review the legal options which may be available by requesting a free consultation. 

Our 10 year old son was diagnosed with an anxiety disorder by a psychologist pursuant to taking Singulair and we can document the connection.  I am a civil litigation assistant for a small firm in Iowa and would be willing to serve as a lead plaintiff should there be any action pursued against Merck for failing to disclose the potential side effects of Singulair.  My brother was on Singulair from June of 2002 until his suicide in June of 2004.  In clinical trials, only 1 patient attempted suicide in the singulair group, whereas 3 patients did so in other asthma medicine groups.  I was an easy going person who was really easy to get along with and always relaxed before starting on Singulair.  I’m off of the singulair now and starting to feel like my old self again but it’s too late for my family.  I don’t know the relation of these episodes and the Singulair.  My 8 year old daughter has been taking singulair for 4 years due to allergies and asthmatic symptoms. 

 

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I joke with my girlfriend calling singulair “my angry medicine,” she doesn’t think it’s very funny though.  I’m typically a very calm guy but this medicine makes makes my mood very mad, I just can’t control the anger i feel, i never feel or have every felt that way except when taking singulair.  My son is 11 years old and has been on the adult dose of singulair since 2005 and just until recently after hearing of the side effects of Singulair was I able to connect his severe anxiety and depression to the medication.  He has suffered for over two years and continued to take it  for his asthma and allergies even after I asked his doctors if there was any link after he started showing symtoms of anxiety and depression at the age of 9.  My 14 yr old son was on singulair for three and a half years and after two months anxiety and sadness set in, a year and a half later it was severe depression to the point he was hospitalized.

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What are some possible side effects of Singulair?

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 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 corticosteroidsSide 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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