In five hundred and ten atopic children aged between 12-24 months who received 0.125 mg/kg Levocetirizine twice daily for 18 months the following adverse reactions were observed in Levocetirizine (L) and placebo (P) treated infants; Wheezing:
L 4.7%, P 7.5%. Atopic Dermatitis:
L 1.2%, P 2.4%. Gastroenteritis:
L 0.8%, P 2.0%. Cough:
L 1.6%, P 0.8%. Bronchopneumonia:
L 1.6%, P 0.4%. Febrile Convulsion:
L 1.6%, P 0.0%. Urticaria:
L 0.4%, P 1.2%. Chronic Bronchitis:
L 0.0%, P 1.2%. Pneumonia:
L 0.8%, P 0.0%. The frequency of adverse events, serious adverse events, medication attributed adverse events and adverse events that led to permanent discontinuation of study medication were not significantly different from placebo. A total of 243 pediatric patients 6 to 12 years of age received Levocetirizine 5 mg once daily in two short-term placebo controlled double-blind trials. The mean age of the patients was 9.8 years, 79 (32%) were between 6-8 years of age. The adverse reactions that were reported in greater than or equal to 2% of subjects aged 6-12 years exposed to Levocetirizine 5 mg in placebo-controlled clinical trials and that were more common with Levocetirizine (L) than placebo (P) were as follows; Pyrexia:
L 4%, P 2%. Cough:
L 3%, P (<1%). Somnolence:
L 3%, P <1%. Epistaxis:
L 2%, P <1%.
Laboratory Test Abnormalities:
Elevations of blood bilirubin and transaminases were reported in <1% of patients in the clinical trials. The elevations were transient and did not lead to discontinuation in any patient. In addition to the adverse reactions reported during clinical trials and listed previously, adverse events have also been identified during post-approval use of Levocetirizine in adults and or children. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Adverse events of hypersensitivity and anaphylaxis, angioneurotic edema, fixed drug eruption, pruritus, rash, and urticaria, convulsion, aggression and agitation, visual disturbances, palpitations, dyspnea, nausea, hepatitis, and myalgia have been reported. Besides these events reported under treatment with Levocetirizine, other potentially severe adverse events have been reported from the post-marketing experience with cetirizine. Since Levocetirizine is the principal pharmacologically active component of cetirizine, one should take into account the fact that the following adverse events could also potentially occur under treatment with Levocetirizine: hallucinations, suicidal ideation, orofacial dyskinesia, severe hypotension, cholestasis, glomerulonephritis, and still birth.
Suppression of the hypothalamic-pituitary-adrenal axis, growth suppression in infancy, childhood and adolescence, menstrual irregularity and amenorrhea. Cushingoid facies, hirsutism, weight gain, impaired carbohydrate tolerance with increased requirement for antidiabetic therapy. Negative protein, nitrogen and calcium balance. Increased appetite. Hyperhydrosis. Increased high-density lipoprotein and low-density lipoprotein concentrations in the blood.
Anti-inflammatory and immunosuppressive effects:
Increased susceptibility to and severity of infections with suppression of clinical symptoms and signs, opportunistic infections, recurrence of dormant tuberculosis.
Osteoporosis, vertebral and long bone fractures, avascular osteonecrosis, tendon rupture, proximal myopathy.
Fluid and electrolyte disturbance:
Sodium and water retention, hypertension, potassium loss, hypokalaemic alkalosis.
A wide range of psychiatric reactions including affective disorder (such as irritable, euphoric, depressed and labile mood and suicidal thoughts), psychotic reactions (including mania, delusions, hallucinations and aggravation of schizophrenia), behavioral disturbances, irritability, anxiety, sleep disturbances and cognitive dysfunction including confusion and amnesia have been reported. Reactions are common any may occur in both adults and children. In adults, the frequency of severe reactions has been estimated to the 5-6%. Psychological effects have been reported on withdrawal of corticosteroids; the frequency is unknown. Aggravation of epilepsy.
Increased intra-ocular pressure, glaucoma, papilloedema, posterior subcapsular cataracts, corneal or scleral thinning and exacerbation of ophthalmic viral or fungal diseases.
Myocardial rupture following recent myocardial infarction.
Abdominal distension, esophageal ulceration, nausea, dyspepsia, peptic ulceration with perforation and haemorrhage, acute pancreatitis, candidiasis.
Impaired healing, skin atrophy, bruising, telangiectasia, striae, acne.
Hypersensitivity including anaphylaxis has been reported. Leucocytosis. Thrombo-embolism. Malaise. Hiccups.
Withdrawal symptoms and signs:
Too rapid a reduction of corticosteroid dosage following prolonged treatment can lead to acute adrenal insufficiency, hypotension and death. A 'withdrawal syndrome' may also occur including; fever, myalgia, arthralgia, rhinitis, conjunctivitis, painful itchy skin nodules and loss of weight.