Adverse drug reaction of the month--a new series.

Editorial Adverse drug reaction of the month-a new series This issue of the Postgraduate Medical Journal sees the launch of a new series of articles, Adverse drug reaction of the month. The series has two objectives. First, it is intended to inform practising clinicians about significant adverse reactions (ADRs), as well as their diagnosis, management and prevention. Second, we unashamedly wish to use it to promote the Committee on Safety of Medicines/Medicine Control Agency (CSM/MCA) 'yellow card' scheme. The series will be based on individual case reports, or case-series, derived from the CSM/MCA's ADR database. The case reports will generally be provided by the staff of the CSM/MCA's Regional Monitoring Centre (in Wales, West Midlands, Merseyside and the Northern Region). The case-series will usually be assembled by staff of the MCA's Postlicensing Division and will examine ADR profiles for individual, or classes of, products. The CSM and MCA have always regarded the confidentiality of the 'yellow card' scheme as inviolate and neither the names of patients or reporting doctors are divulged to third parties. Case-reports will therefore be anonymised and only published with the consent of the reporting doctor. Further some minor changes (eg, patient's age, gender) may be Table Important early warnings of new adverse reactions identified through spontaneous ADR reporting schemes since 1993 and the resultant UK action in respect of marketing authorisations/product information Year Product Adverse reaction and resultant action 1993 thymoxamine (Opilon) hepatotoxicity led to improved warnings 1993 clozapine (Clozaril) myocarditis led to warnings 1993 paroxetine (Seroxat V) withdrawal symptoms, dystonic reactions led to improved warnings 1993 remoxipride (Roxiam V) aplastic anaemia led to drug withdrawal worldwide 1993 high-lipase pancreatins colonic strictures in children with (Creon 25000 V, cystic fibrosis led to advice to use Nutrizym 22 V, lower strength pancreatins in this Pancrease HL V, group Panzytrat 25000 V) 1994 rifabutin (Myobutin V) uveitis and drug interactions led to warnings and dose reduction 1994 halofantrine (Halfan V) cardiac arrhythmias led to additional warnings and contraindica-tions 1994 tiaprofenic acid severe cystitis led to additional (Surgam) warnings and contraindications 1995 tramadol (Zydol V) psychiatric reactions led to warnings 1995 cyproterone acetate dose-related hepatoxicity led to (Cyprostat Androcur) restricted indications and the requirement for hepatic function monitoring 1995 quinolone antibiotics tendonitis and tendon rupture led to improved warnings 1995 tacrolimus (Prograf V) hypertrophic cardiomyopathy led to warnings, dose reduction and monitoring requirement 1996 alendronate oesophageal reaction led to …