Dimethyl fumarate and alopecia

09-10-2020

The Netherlands Pharmacovigilance Centre Lareb has received 92 cases about alopecia associated with the use of dimethyl fumarate. Alopecia is not described in the Dutch Summary of Product Characteristics of dimethyl fumarate containing products.

Dimethyl fumarate was continued in most cases and most patients had not recovered from the alopecia. Time to onset varied from several weeks up to months after start. Most reports were from marketing authorization holders and were received in the last 2 years, which is possibly also related to the increase in number of patients using dimethyl fumarate. The association between dimethyl fumarate is disproportionate in the Lareb, EudraVigilance and WHO databases.

Dimethyl fumarate is an immunomodulating agent that is used in the treatment of plaque psoriasis (Skilarence) and relapsing remitting multiple sclerosis (Tecfidera). The majority of cases was received for patients using dimethyl fumarate for the indication multiple sclerosis. Alopecia areata has been described in patients with multiple sclerosis. Most of the reports received by Lareb however concern diffuse alopecia and not alopecia areata.

Read here the analysis of the reports.