Revue de Pharmacovigilance

Abstrait

Two Unexpected Cases of Rosacea during Fingolimod Therapy

Brusco S, Bertini M, Scavone C, Docimo R, Bisecco A, Capuano A and Gallo A

Fingolimod is the first orally bioavailable disease modifying agent approved for the management of relapsingremitting multiple sclerosis (RRMS). Even though it is generally well tolerated, it requires a specific monitoring due to its first-dose and long-term toxicity. Although some of the skin adverse events drug-related may be severe, the most frequently reported are non-serious such as alopecia, eczema and pruritus.

In this context, we describe two unexpected cases of fingolimod-induced rosacea occurred in two patients with MS in real life context. A 48-year-old Caucasian woman and a 27-year-old Caucasian male developed rosacea few days after starting treatment with fingolimod. After discontinuation of the treatment the lesions quickly resolved. Fingolimod represents one of the most commonly prescribed medications in patients with multiple sclerosis (MS), nevertheless its safety profile is still not completely known. Our cases contribute to the current knowledge on fingolimod safety profile. Further studies are needed to confirm the link between this drug and rosacea.