Skin is one of the most common targets of adverse drug reactions (ADRs) .
Dermatological ADRs
Skin
is one of the most common targets of adverse drug reactions (ADRs) (Arndt and
Hershel, 1976). Eruptions are observed in 0.1–1% of treated patients in
pre-marketing trials of most drugs, and also in the placebo groups. A number of
drugs of current utiliza-tion are associated with higher rates of skin
eruptions: 5–7% for aminopenicillins, 3–4% for antibacterial sulphonamides and
5–10% for many antiepileptics. In a reported prospective survey, 90% of these
drug erup-tions were benign (Hunziker et
al., 1997). Because under-reporting is expected to be more frequent for
benign reactions, one may assume that severe cuta-neous ADRs account for about
2% of all skin reac-tions.
The
Council for International Organization of Medi-cal Sciences (CIOMS) considers
as serious ADRs that ‘are fatal or life-threatening, or require prolonged
hospitalization, or result in persistent or significant disability or
incapacity’ (CIOMS, 1997) Because hospitalization may depend on the
socioeconomic status of the patient and on access to health care, we prefer to
consider as severe those drug eruptions that are associated with a definite
risk of increased mortality, even if the risk is low, and whether the risk is
related to ‘acute skin failure’, to associated visceral lesions or to both
factors. Not all severe skin ADRs develop rapidly. Many well-defined clini-cal
entities like drug-induced pemphigus, psoriasis or lupus usually occur after
prolonged exposure.
It
is our opinion that the different clinical patterns of severe drug eruptions
should be distinguished, while others prefer mixing all of them under the
denom-ination of ‘hypersensitivity reactions’ (Knowles, Uetrecht and Shear,
2000). Both conceptions are based on mechanistic considerations. The ‘mergers’
empha-size the role of ‘reactive metabolites’ of drugs as common initiators of
all types of reactions. The ‘split-ters’ underline the differences in clinical
presentation, pathology of skin and visceral lesions, and biologic markers that
suggest that the effector mechanisms are probably different (Roujeau and Stern,
1994).
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