Date approved: February 20, 1998
Status: Prescription only, approved status being reviewed by the FDA
Approved uses: Preventative treatment of asthma and seasonal allergies
Off-Label uses: None
• Stomach pain
• stomach or intestinal upset
• stuffy nose
• upper respiratory infection
• possible connection to increased suicidal thoughts
Singulair is an asthma medication that acts by being a leukotriene inhibitor. Leukotrienes are chemicals the body releases when one breathes in an allergen (such as pollen). These chemicals cause swelling in the lungs and tightening of the muscles around airways, which can result in asthma symptoms. Singulair is proscribed to prevent asthma attacks in adults and children as young as 12 months old. It is also used to relieve runny nose and sneezing caused by allergies in adults and children as young as 6 months old.
In March 2008, reports emerged linking Singulair to increased suicidal thoughts among patients taking the medication. On March 27th, 2008, the FDA announced it was reviewing a possible connection between Singulair and suicidal behavior in adults and children, after receiving reports of mood and behavior changes, suicidal thinking and suicide in patients who had taken the drug. The FDA has recommended that until further information is available, health care professionals and caregivers should monitor patients taking Singulair for any suicidal behaviors or thoughts. Upon the completion of the investigation, the FDA will give its recommendation as to whether Singulair should continue being proscribed to asthma and allergy sufferers.
Singulair FDA Warnings – Possible Connection to Suicidal Thoughts
Singulair, generically known as montelukast sodium, is a medication manufactured and distributed through the pharmeceutical conglomerate Merck and Co. It is used primarily for the prevention and control of asthma and related bronchoconstriction reactions, but has also seen wide use in the prevention and control of allergies related to similar symptoms. It is one of Merck’s most popular drugs in several categories: sales, prescriptions, and revenue generated. According to Merck, it has millions of users across the United States, ranging in age from adults on a maintenance therapy regimen to young children preventing serious asthma reactions during particularly sensitive allergy seasons. It generated upwards of $3.6 billion for the company in 2007 in the United states – and more than $4.3 billion globally. It is Merck’s best selling prescription medicine.
Recently, there have been reports of additional side effects not previously associated with the drug. In the last year alone, Merck has changed the language on the prescribing information four times to include information on a range of newly reported side effects: tremors, anxiousness, depression and suicidal behavior. None of these symptoms were initially listed on the medication, nor did they surface in the controlled studies Merck performed in an analysis of more than 11,000 patients in 40 clinical trials. However, several reports of suicidal thoughts and behaviors have surfaced recently in light of the drug’s ongoing updated warnings.
In one case, a 5-year-old child repeatedly told his mother he “…didn’t want to be in this life anymore…” and exhibited destructive and dangerous behavior toward himself and his family. More recently, television network NBC reported that a couple in New York are blaming their son’s suicide on the medication. Previously, the 15-year-old had been taking another medication to control his allergies. However, just days after making the switch to Singulair, he took his own life. Both of these cases seem representative of other reports linked to the medication; the majority of them have no prior history of psychological problems and are generally healthy and well-adjusted individuals. It seems as if there is a strong link between the drug and these behaviors.
On March 27th, 2008, the FDA announced it was reviewing a possible connection between Singulair and suicidal behavior in adults and children, after receiving reports of mood and behavior changes, suicidal thinking and suicide in patients who took the drug. Additionally, when asked about the number of reports of these suicides linked to the drug, Merck declined comment, but said that they were present in both children and adults. In their announcement, the FDA recommended, “…until further information is available, healthcare professionals and caregivers should monitor patients taking Singulair for suicidality (suicidal thinking and behavior) and changes in behavior and mood.”
As per the FDA’s recommendations, it is strongly suggested that patients taking Singulair or parents who are concerned about potentially dangerous side effects of the medication should consult their primary care physician about their health concerns.
Living With Asthma
There are currently almost 20 million Americans suffering from asthma, and approximately 45 percent of these individuals are children, according to the National Heart Lung and Blood Institute (NHLBI).
Asthma is often associated with allergies, but not all individuals suffering from asthma also suffer from allergies. Asthma commonly begins during childhood and can be continue through to adulthood. However, all individuals are at risk for developing asthma at any age, and, it has been discovered that in boys rather than girls are more likely to suffer from asthma while the reverse is true in adulthood.
According to a USA Today article, approximately 5,300 people die from asthma complications each year and it is the sixth leading cause of chronic disease in America, costing nearly $9.8 billion annually.
Signs and Symptoms of Asthma
Asthma can be considered a serious risk to one�s health if left untreated, however, millions of adults as well as children can live comfortable with asthma as long as appropriate treatment is sought and discussed with a health professional.
Recognizing the signs and symptoms of asthma is the first step in overcoming the disease that can cause death in extreme cases. Symptoms of asthma include:
• coughing, especially during the evenings causing sleep difficulties
• when breathing, asthma victims often have wheezing breaths that may sound as if they are whistling or squeaking
• chest tightness
• shortness of breath as well as struggling to breath
• faster than normal breathing
• very noisy breathing
Additionally, symptoms often vary from individual to individual; some asthma suffers will have severe symptoms while others will only notice a slight to mild discomfort. It is important for a patient of asthma to note several things that a doctor will likely inquire about to better diagnose their asthma. Recording what time of year/season a coughing fit occurs, what causes symptoms to worsen, family history of asthma/allergies, chest colds and which medications alleviate asthma symptoms.
There are an array of treatments for asthma that can be divided into two categories including quick relief and long relief medications. Quick relief medications are commonly prescribed to all asthma sufferers as a rescue medication to halt an asthma attack or asthma symptoms before a condition becomes uncontrollable. Usually short asthma treatments consist of inhalers that cause the airways to open up and relax the muscles, which are causing the asthma attack, according to the National Library of Medicine (NLM).
Patients suffering from asthma who have taken Singulair may be at risk for any of these side effects, however, those who have taken the drug and who are showing signs of suicidal thoughts and actions should seek medical attention immediately. Additionally, consulting with an experienced pharmaceutical attorney may offer assistance in developing a Singulair lawsuit.