Stronger safety warnings coming for alopecia medicine Litfulo
Product information for the alopecia medicine Litfulo will carry stronger warnings about cardiovascular disease, blood clots, cancer and serious infections, Sweden's Medical Products Agency says.
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The change follows a safety review by the European Medicines Agency's PRAC committee. Similar warnings already apply to other medicines in the JAK-inhibitor class and were judged relevant to Litfulo, according to the Swedish agency.
A boxed warning will state that Litfulo should be used only when no suitable alternative is available for patients aged 65 or older, people with a history of cardiovascular disease or other cardiovascular risk factors, including long-term current or former smokers, and patients with previous or current cancer.
Litfulo is an immune-modulating treatment for adults and adolescents aged 12 and over with severe alopecia areata, an autoimmune condition that causes hair loss. Healthcare professionals will receive a letter explaining the new risk-reduction measures.
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