Singulair's FDA Approved Label carries a "WARNING/PRECAUTION" about NEUROPSYCHIATRIC SIDE EFFECTS AND SYSTEMIC EOSINOPHILIA sometimes presenting with clinical features of VASCULITIS consistent with Churg-Strauss syndrome.
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, disorientation [confusion], disturbance in attention, dream abnormalities, hallucinations, insomnia, irritability, memory impairment, restlessness, somnambulism [sleep walking], 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.
The FDA previously recommended that healthcare professionals should consider discontinuing these medications (Singulair, Accolate, Zyflo and Zyflo CR) if patients develop neuropsychiatric symptoms. In clinical trials, sleep disorders (primarily insomnia) were reported more frequently with these products compared to placebo.
Patients with asthma on therapy with SINGULAIR may present with systemic eosinophilia and clinical features of vasculitis consistent with Churg-Strauss syndrome. These events have been sometimes associated with the reduction of oral corticosteroid therapy. Physicians should be alert to eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy in patients.
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.
*Information complied from Singulair's "Patient Information" and "Prescribing Information." Please visit www.singulair.com and read both the Patient and Prescribing Information in the event changes have been made since this list was updated. Singulair may have other side effects. Visitwww.parentsforsafety.org for more information.