[Skin toxicity related to Percutalgine(®): analysis of the French pharmacovigilance database].

BACKGROUND

Percutalgine(®) (dexamethasone acetate, salicylamide and hydroxyethyl salicylate) is a topical drug marketed for treatment of benign joint conditions such as mild tendinitis, small joint arthritis and sprains. The aim of the study was to describe the cutaneous side effects of Percutalgine(®) in terms of clinical signs, seriousness and causal relationship of the different components.

METHODS

We extracted from the French Pharmacovigilance database all cases of adverse skin reactions occurring after application of Percutalgine(®) and reported for the period between 1st January 2000 and 31st October 2010. The only files selected were those in which Percutalgine(®) was the sole suspected drug and/or allergological tests were positive for Percutalgine(®) or its components.

RESULTS

Fifty-three cases were ultimately retained and analysed. The main cutaneous side effect of Percutalgine(®) (n=41) was contact dermatitis with secondary extension in 15 cases. Onset was immediate in 12 cases, delayed in 32 cases and unspecified in eight cases. Twelve patients were hospitalized for inefficiency of the symptomatic treatment, extended lesions or generalized associated signs. Allergological tests were described in 14 cases and were positive for Percutalgine(®) (eight cases), hydroxyethyl salicylate (seven cases), salicylamide (six cases), dexamethasone (three cases), and propylene glycol (two cases).

CONCLUSION

Cutaneous side effects with Percutalgine(®) appear to be rare or infrequently reported. They consist chiefly of contact allergy. The component responsible for the reaction can be determined using allergological patch tests.