Why is pharmacovigilance important?
Pharmacovigilance consists of information gathering, monitoring and evaluation of data, and risk management throughout a drug products life cycle. The goals of the process include: • Record of suspicions from clinicians • Early detection of signals • Appropriate and timely causality assessment • Minimization of negative effects to health of paediatric patients • Timely drug recall, if judged appropriate. An ADR report denotes a temporal association but does not prove causation. Such an association is sufficient to make a report. Please report all serious adverse drug reactions (ADRs). Top of page July 2009 Purple glove syndrome Rare complication of intravenous phenytoin Progressive distal limb edema, discoloration and pain are rare complications occurring after intravenous phenytoin use and are known as the purple glove syndrome. Physicians should: • Identify manifestations early to prevent damage to hand and arm. • Limit infusion of phenytoin to a rate of less than 50 mg/min. • Treat
