Adverse drug reactions: Monastir pharmacovigilance experience

Adverse drug reactions are frequent and may be potentially life threatening. The aim of our study was to evaluate epidemiological, clinical and chronological characteristics of adverse drug reactions and to identify implicated dugs. We involved in our retrospective study all suspected adverse drug reactions notified to the Pharmacovigilance Unit of Monastir during 45 months [2004-2007]. Imputability was established according to Begaud's method et al. Two hundred and seventy seven events thought to be adverse reactions to drugs were notified to our unit. One hundred and fifty seven [56.6%] were judged as being related to drugs. Patients were 77 men and 80 women. [Median: 39 years]. Most frequent adverse drug reactions were skin eruptions [n=111], liver injury [n=16] and pseudo parkinson syndrome [n=13]. Other adverse effects were anaphylactic symptoms, haematological reactions and tendinits. Skin eruptions were mainly induced by betalactam agents [35% of cases] and other anti infectious agents [30%]. Skin eruptions were the most notified adverse drug effects and antibiotics were the most implicated agents

[Drug rash with eosinophilia and systemic cymptoms [DRESS syndrome] associated with sulfasalazine and human herpesvirus 6 infection successfully treated with steroid therapy]

We report a case of a 30-year-old man who developed a generalized erythematous skin eruption, fever, lymphadenopathy, hepatic cytolysis and eosinophilia probably due to sulfasalazine. Indirect immunofluorescence assay for Human herpesvirus-6 [HHV-6] was positive, supporting recent HHV-6 infection. The patient was successfully treated with dexamethasone. The case is reported with a review of the literature. DRESS syndrome mechanisms and management are also discussed