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Updates to section 4.8, following the submission of the PSUR. The entire format has changed, so changes are not bolded. Section 10 updated.
4.8. Undesirable Effects
The incidence of predictable undesirable effects, including hypothalamo-pituitary-adrenal (HPA) suppression, correlates with the relative potency of the drug, dosage, timing of administration and the duration of treatment (see Section 4.4).
The following side effects may be associated with the long-term systemic use of corticosteroids.
Infections and Infestations
Increased susceptibility and severity of infections with suppression of clinical symptoms and signs, opportunistic infections, recurrence of dormant tuberculosis (see section 4.4).
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Kaposi’s sarcoma has been reported to occur in patients receiving corticosteroid therapy. Discontinuation of corticosteroids may result in clinical remission.
Blood and lymphatic system disorders
Leukocytosis.
Immune system disorders
Hypersensitivity including anaphylaxis has been reported.
Endocrine disorders
Suppression of the HPA axis.
Cushingoid.
Impaired carbohydrate intolerance with increased requirement for anti-diabetic therapy, manifestation of latent diabetes mellitus.
Metabolism and nutrition disorders
Sodium and water retention, hypokalaemia, hypokalaemic alkalosis, increased appetite, negative protein and calcium balance.
Psychiatric disorders
Euphoric mood, psychological dependence, depressed mood, insomnia, aggravation of schizophrenia.
A wide range of psychiatric reactions including affective disorders (such as irritable, euphoric, depressed and labile mood, and suicidal thoughts), psychotic reactions (including mania, delusions, hallucinations, and aggravation of schizophrenia), behavioural disturbances, irritability, anxiety, sleep disturbances, and cognitive dysfunction including confusion and amnesia have been reported. Reactions are common and may occur in both adults and children. In adults, the frequency of severe reactions has been estimated to be 5-6%. Psychological effects have been reported on withdrawal of corticosteroids; the frequency is unknown.
Nervous system disorders
Dizziness, headache.
Increased intracranial pressure with papilloedema in children (pseudotumour cerebri) -usually after treatment withdrawal.
Aggravation of epilepsy.
Eye disorders
Glaucoma, papilloedema, posterior subcapsular cataracts, central serous chorioretinopathy, exophthalmos, corneal or scleral thinning, exacerbation of ophthalmic viral or fungal diseases.
Ear and labyrinth disorders
Vertigo
Cardiac disorders
Myocardial rupture following recent myocardial infarction.
Congestive cardiac failure (in susceptible patients).
Vascular disorders
Hypertension, embolism.
Respiratory, thoracic and mediastinal disorders
Hiccups.
Gastrointestinal disorders
Dyspepsia, nausea, vomiting, abdominal distension, abdominal pain, diarrhoea, oesophageal ulceration, candidiasis, pancreatitis acute.
Peptic ulceration with perforation and haemorrhage.
Skin and subcutaneous tissue disorders
Skin Atrophy, skin striae, acne, telangiectasia, hyperhidrosis, rash, pruritus, urticaria, hirsutism.
Musculoskeletal and connective tissue disorders
Myopathy, osteoporosis, vertebral and long bone fractures, avascular osteonecrosis, myalgia.
Growth retardation in infancy, childhood and adolescence.
Reproductive system and breast disorders
Menstruation irregular, amenorrhoea.
General disorders and administration site conditions
Impaired healing, malaise.
Investigations
Weight increased.
Injury, poisoning and procedural complications
Tendon rupture, contusion (bruising).
Withdrawal Symptoms
Too rapid a reduction of corticosteroid dosage following prolonged treatment can lead to acute adrenal insufficiency, hypotension and death (See Section 4.4)
A ‘withdrawal syndrome’ may also occur including fever, myalgia, arthralgia, rhinitis, conjunctivitis, painful itchy skin nodules and loss of weight.
In some instances, withdrawal symptoms may involve or resemble a clinical relapse of the disease for which the patient has been undergoing treatment.
Other effects that may occur during withdrawal or change of corticosteroid therapy include benign intracranial hypertension with headache and vomiting and papilloedema caused by cerebral oedema.
Latent rhinitis or eczema may be unmasked.
10. DATE OF (PARTIAL) REVISION OF THE TEXT
March 2010
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