Up­dat­ed: FDA adds warn­ing of 'larg­er ar­eas of bleed­ing' in brain to Bio­gen's Aduhelm la­bel

The FDA last week signed off on a safe­ty-re­lat­ed change to the la­bel of Bio­gen’s con­tro­ver­sial Alzheimer’s drug Aduhelm, which has bare­ly mus­tered any sales since its ap­proval be­cause pay­ers have re­fused to cov­er it.

The new la­bel makes clear that physi­cians should, “In­form pa­tients that events of in­trac­ere­bral he­m­or­rhage greater than 1 cm in di­am­e­ter have been re­port­ed in­fre­quent­ly in pa­tients tak­ing ADUHELM, and that the use of an­tithrom­bot­ic or throm­bolyt­ic med­ica­tions while tak­ing ADUHELM may in­crease the risk of bleed­ing in the brain.”

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