D3.83 - A Case Report of Fenofibrate-Induced Fixed Drug Eruption Documented by Patch Testing and Oral Provocation

Introduction.

Fixed drug eruption (FDE) is a well-known cutaneous adverse reaction that can occur with lipid-lowering agents, such as statins and PCSK9 inhibitors. However, FDE associated with fibrates has not been well-documented, despite other skin reactions related to fibrates, such as lichenoid drug eruption, photosensitivity, Stevens-Johnson syndrome and toxic epidermal necrolysis being published.

Case presentation.

We report a 56-year-old male with a personal history of dyslipidemia and chronic spontaneous urticaria with angioedema, who developed pruritus and paresthesia of both hands approximately 30 minutes after the administration of fenofibrate and atorvastatin. Approximately 12 hours later, hand edema and multiple erythematous macules developed, which persisted for nearly one month and gradually evolved to a violaceous appearance. A more detailed medical history revealed that the patient had experienced a similar episode 15 years earlier, characterized by erythematous macules on the hands accompanied by violaceous vesicles, which appeared after treatment with fenofibrate.

Drug patch tests were performed using aqueous solutions of fenofibrate 30% and atorvastatin 30%. Both patch tests were negative at 48- and 72-hour readings.

A graded oral drug provocation test (DPT) was performed afterwards, with fenofibrate, and in about 40 minutes after the first dose (72,5 mg) and 10 minutes after the second dose (cumulative dose: 145 mg), the patient developed pruritus and mild edema of both hands, followed by multiple erythematous macules locally. These lesions evolved into violaceous macules after 10 hours and were associated with bullae, despite treatment with occlusive topical corticosteroid (mometasone 1 mg/g cream). Corticosteroid i.m. therapy with dexamethasone was initiated, leading to a favorable evolution of the lesions until discharge. Interestingly, the patch test with fenofibrate became weakly positive at 130 hours, despite systemic corticotherapy. It is important to mention that a DPT with atorvastatin (cumulative dose: 20 mg) was negative.

Conclusions.

To our knowledge, this is the first confirmed case of FDE caused by fenofibrate documented with patch testing and oral provocation, highlighting the importance of a detailed patient history and a proper allergy workup in individuals suspected of FDE due to lipid-lowering drugs.