Opdivo® (nivolumab) – New warnings
October 4, 2016 – The FDA approved new updates to the Warnings and Precautions section of the Opdivo (nivolumab) drug label, regarding new adverse reactions identified through Bristol Myers Squibb’s pharmacovigilance program or in study CA209017: Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), myositis, myocarditis, and rhabdomyolysis.
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