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FDA fires off a warn­ing on rare cas­es in­volv­ing death, ad­verse liv­er events linked to mis­use of 3 big hep C drugs

Just as one prob­a­bly er­rant drug safe­ty ru­mor was be­ing de­bunked at Ver­tex, the FDA trig­gered a re­al alarm on a trio of promi­nent hep C drugs now linked with a lethal liv­er re­ac­tion.

Ab­b­Vie’s Mavyret, Mer­ck’s now deeply dis­count­ed drug Zepati­er and Gilead’s Vo­se­vi were in­volved in 63 cas­es of liv­er de­com­pen­sa­tion — in­ci­dents of liv­er dys­func­tion — which in­cludes some deaths, ac­cord­ing to the FDA. Most suf­fered from sig­nif­i­cant liv­er im­pair­ment and should nev­er have been pre­scribed the drug to be­gin with. And the agency wants to find out if there are more.

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