EMA de­vel­op­ing physi­cian guid­ance for po­ten­tial liv­er dam­age af­ter tak­ing Zol­gens­ma

The Eu­ro­pean Med­i­cines Agency is work­ing on new ad­vice for health­care providers treat­ing pa­tients with Zol­gens­ma, five months af­ter two child pa­tient deaths in Rus­sia and Kaza­khstan.

That in­cludes mon­i­tor­ing the liv­er func­tion of pa­tients treat­ed with the gene ther­a­py and quick­ly as­sess­ing cas­es of sus­pect­ed liv­er dam­age, Reuters first re­port­ed.

The EMA re­leased its own state­ment af­ter the Phar­ma­covig­i­lance Risk As­sess­ment Com­mit­tee meet­ing on Jan. 12:

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