COMMITTEE ON SAFETY OF MEDICINES MEDICINES CONTROL AGENCY

WHAT IS A SERIOUS REACTION

Serious reactions include those that are fatal, life-threatening, disabling, incapacitating or which result in or prolong hospitalisation.

The following list provides guidance on the identification of serious ‘medically significant’ reactions for which we would hope to receive reports.

Some examples of serious reactions

Blood Bone marrow dyscrasias Coagulopathies Haemolytic anaemias Cardiovascular Arrhythmias Cardiac arrest Cardiac failure Cardiomyopathy Circulatory failure Hypertension Hypotension Myocardial ischaemia/infarction Sudden death Central nervous system Anorexia nervosa Catatonia Cerebrovascular accident Coma Confusional state Dependence Depression Epilepsy (inc. exacerbations) Extrapyramidal reactions Hallucinations Hyperpyrexia Intracranial hypertension Myasthenia Neuroleptic malignant syndrome Neuropathy Psychosis Withdrawal syndrome

Gastrointestinal Colitis Haemorrhage Hepatic cirrhosis Hepatic dysfunction Hepatic fibrosis Ileus Pancreatitis Perforation Peritonitis (inc. fibrosing) Pseudo-obstruction Immunological Anaphylaxis Arteritis Drug fever Graft rejection Lupus syndrome Polyarteritis nodosa Vasculitis Malignancy Any Metabolic Acidosis Adrenal dysfunction Hypercalcaemia Hyperkalaemia Hypokalaemia Hyponatraemia Pituitary dysfunction Porphyria Thyroid dysfunction

Musculoskeletal Arthropathy Aseptic bone necrosis Myopathies Osteomalacia Pathological fracture Renal Renal dysfunction Urinary retention Reproduction Abortion Antepartum haemorrhage Congenital abnormalities Eclampsia, pre-eclampsia Infertility Uterine haemorrhage, perforation Respiratory Alveolitis (allergic fibrosing) Bronchospasm (inc. exacerbation) Pneumonitis Respiratory failure Thromboembolism Skin Angiodema Bullouseruptions Epidermal necrolysis Exfoliation (generalised) Special senses Cataract Corneal opacification Glaucoma Hearing loss Vestibular dysfunction Visual loss

Remember!

For new drugs (identified by an inverted black triangle symbol in the British National Formulary, MIMS, ABPI Data Sheets and Summaries of Product Characteristics), we request reports for ALL suspected reactions, while for more established drugs only SERIOUS reactions should be reported.

 If in doubt report

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