{"id":8458,"date":"2025-11-18T23:02:20","date_gmt":"2025-11-18T23:02:20","guid":{"rendered":"https:\/\/mailitics.com\/index.php\/2025\/11\/18\/fda-warning-on-sarepta-gene-therapy-for-muscular-dystrophy\/"},"modified":"2025-11-18T23:02:20","modified_gmt":"2025-11-18T23:02:20","slug":"fda-warning-on-sarepta-gene-therapy-for-muscular-dystrophy","status":"publish","type":"post","link":"https:\/\/mailitics.com\/index.php\/2025\/11\/18\/fda-warning-on-sarepta-gene-therapy-for-muscular-dystrophy\/","title":{"rendered":"STAT+: FDA\u2019s stronger warning on Sarepta gene therapy raises new questions about heart risk"},"content":{"rendered":"

STAT+: FDA\u2019s stronger warning on Sarepta gene therapy raises new questions about heart risk
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New warnings and restrictions placed on Sarepta Therapeutics\u2019 gene therapy last week by the Food and Drug Administration have cast a spotlight on an important but overlooked heart-safety risk.<\/p>\n

\u201cAcute, serious, and life-threatening\u201d cases of heart inflammation called myocarditis and elevations of troponin-I, a protein released by dying heart-muscle cells, have been reported in patients treated with Elevidys, Sarepta\u2019s gene therapy for Duchenne muscular dystrophy<\/a>, according to its prescribing label updated on Friday.\u00a0<\/p>\n

A previous version of the Elevidys label noted only that \u201cacute and serious\u201d myocarditis and troponin-I elevations had been observed.\u00a0<\/p>\n

Continue to STAT+ to read the full story\u2026<\/a><\/p>\n<\/div>\n

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\n Adam Feuerstein and Jason Mast
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STAT+: FDA\u2019s stronger warning on Sarepta gene therapy raises new questions about heart risk New warnings and restrictions placed on Sarepta Therapeutics\u2019 gene therapy last week by the Food and Drug Administration have cast a spotlight on an important but overlooked heart-safety risk. \u201cAcute, serious, and life-threatening\u201d cases of heart inflammation called myocarditis and elevations […]<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[2194,2154,2433,2146,2659,1428,2176,2678,2152],"tags":[2150],"class_list":["post-8458","post","type-post","status-publish","format-standard","hentry","category-biotech","category-biotechnology","category-childrens-health","category-fda","category-gene-therapy","category-health","category-pharma","category-rare-diseases","category-stat","tag-statnews"],"_links":{"self":[{"href":"https:\/\/mailitics.com\/index.php\/wp-json\/wp\/v2\/posts\/8458"}],"collection":[{"href":"https:\/\/mailitics.com\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/mailitics.com\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/mailitics.com\/index.php\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/mailitics.com\/index.php\/wp-json\/wp\/v2\/comments?post=8458"}],"version-history":[{"count":0,"href":"https:\/\/mailitics.com\/index.php\/wp-json\/wp\/v2\/posts\/8458\/revisions"}],"wp:attachment":[{"href":"https:\/\/mailitics.com\/index.php\/wp-json\/wp\/v2\/media?parent=8458"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/mailitics.com\/index.php\/wp-json\/wp\/v2\/categories?post=8458"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/mailitics.com\/index.php\/wp-json\/wp\/v2\/tags?post=8458"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}