Singulair’s label was recently updated to include hostility and somnambulism (sleep walking) as side effects, and the following Precaution:
"Neuropsychiatric events have been reported in adult, adolescent, and pediatric patients taking SINGULAIR. Post-marketing reports with SINGULAIR use include agitation, aggressive behavior or hostility, anxiousness, depression, dream abnormalities, hallucinations, insomnia, irritability, restlessness, somnambulism, suicidal thinking and behavior (including suicide), and tremor. The clinical details of some post-marketing reports involving SINGULAIR appear consistent with a drug-induced effect. Patients and prescribers should be alert for neuropsychiatric events. Patients should be instructed to notify their prescriber if these changes occur. Prescribers should carefully evaluate the risks and benefits of continuing treatment with SINGULAIR if such events occur."
These changes are a result of the FDA's Safety Review of Singulair. On June 12, 2009, FDA advised that patients and healthcare professionals should be aware of the potential for neuropsychiatric events with Singulair (and also Accolate, Zyflo, and Zyflo CR), and recommended that healthcare professionals should consider discontinuing these medications if patients develop neuropsychiatric symptoms. In the clinical trial data submitted for these drugs, sleep disorders (primarily insomnia) were reported more frequently with all three products compared to placebo.
OTHER POSSIBLE SIDE EFFECTS OF SINGULAIR* Weakness, fatigue, tiredness, fever, edema, dental pain, increased bleeding tendency, nosebleed, bruising, pharyngitis (sore throat), laryngitis, tonsillitis, conjunctivitis, otitis (ear infection/inflammation), ear pain, palpitations; Digestive/Gastrointestinal disorders: abdominal pain, stomach pain, stomach or intestinal upset, heartburn, indigestion [including belching and bloating], nausea, vomiting, diarrhea, infectious gastroenteritis, pancreatitis; Musculoskeletal disorders: joint pain (arthralgia), muscle pain (myalgia) and cramps; Nervous system disorders: dizziness, headache, drowsiness, pins and needles/numbness (paraesthesia/hypoesthesia), seizures, convulsions; Respiratory disorders: cough, nasal congestion, sinusitis (inflammation/infection of the sinuses), upper respiratory infection, rhinitis (runny nose), flu, bronchitis, wheezing, pneumonia; Skin and subcutaneous tissue disorders: rash (dermatitis), eczema, hives (urticaria), itch (pruritus), angioedema, erythema nodosum; Hepatobiliary disorders: hepatitis, liver-injury; Urinary disorders: pus in the urine (pyuria); Allergic reactions, including swelling of the face, lips, tongue or throat that can cause trouble breathing and/or swallowing, hives. Some patients may present with systemic eosinophilia, and clinical features of vasculitis consistent with Churg-Strauss syndrome. Physicians should be alert to eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy in patients; a causal relationship with Singulair has not been established.
*This list of possible side effects was compiled on 8/28/09 from Singulair's "Patient Information" and the Adverse Reactions and Post-marketing Experience sections of Singulair's "Prescribing Information." You are strongly encouraged to visit www.singulair.com and read both the Patient and Prescribing Information in case changes have been made since this list was compiled. Singulair may have other side effects. Visitwww.parentsforsafety.org for more information.
NOTE: Consumer Medication Information (CMI) distributed by pharmacies with prescriptions is NOT regulated by the FDA and may not list all the side effects on Singulair’s label.http://www.parentsforsafety.org/17601/10701.html
