Could sulindac and fenfluramine give rise to allergic exanthema?/nA 40-year-old woman has been trea

Fråga: Could sulindac and fenfluramine give rise to allergic exanthema?

A 40-year-old woman has been treated for back pain with sulindac (Clinoril) (dose unknown) for several years, but not continuously. The patient has also received fenfluramine (Ponderal), one tablet x2/day as a licensed drug, since October 1992 for obesity. The patient has now developed allergic exanthema on her face, neck and breast, which lasted for three days. Cortisone treatment produced a good effect.

Sammanfattning: Exanthema has been reported as a side-effect of both sulindac and fenfluramine. Cutaneous adverse reactions seem to be common for NSAIDs. However, the incidence of cutaneous reactions in response to these drugs is largely unknown.

Svar: Cutaneous reactions are not considered uncommon in patients treated with NSAIDs (1). However, the true incidence of cutaneous reactions caused by various NSAIDs is largely unknown due to methodological problems. The range of frequency of skin rashes reported in some of the largest and best-performed studies of sulindac is 0 to 11 per cent (cf 1).

Dermatological side-effects of NSAIDs may be both a manifestation of toxicity and an association with systemic hypersensitivity or other allergic reactions (cf 1). In the former case, the toxicity (ie the phototoxic effect) is more dose dependent while in the latter case immunological mechanisms are involved.

A variety of adverse cutaneous reactions have been reported to be associated with sulindac treatment. The morbilliform exanthemae are the most frequently reported (cf 1).

A case of a severe reaction to sulindac has recently been reported (2). An initial course of therapy produced an unrecognised sensitization to the drug with febrile illness and rash. Readministration of the drug caused an anaphylactoid reaction as well as dysfunction of several organs (2).

Between 1978 and 1992, 140 cases of skin reactions have been reported to the Swedish Adverse Drug Reactions Advisory Committee (SADRAC). Of those, there are 59 cases of exanthema, 22 cases of urticaria, 11 cases of Quincke´s oedema, 11 cases of multiform erythema, 8 cases of itching et cetera.

Fenfluramine was removed from the Swedish market in 1988 because of its serious psychiatric side-effects such as depression. Skin reactions were not the most common side-effect of the drug. The common adverse effects included diarrhoea, tiredness, dizziness, dry mouth, headache, sleep disturbances, vision disturbances, hypotension, impotence, libido changes and so on (3). SADRAC received reports of four cases of skin reactions and 19 cases of psychiatric side-effects between 1985 and 1988. Of the four cases of skin reactions there were one case of urticaria, one case of exanthema and two cases of defluvium. 1 Side effects of drugs. Ed by MNG Dukes. Elsevier, Amserdam. 1989; Annual 13: 72-78 2 Hyson CP, Kacakoff MA: A severe multisystem reaction to sulindac. Arch Intern Med 1991; 151: 387-388 3 Drugline nr 08571 (year 1991) (enclosed)