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Kidney diseases / Electrolyte disturbances / Organochlorides / Ciliopathy / Tolvaptan / Hyponatremia / Polycystic kidney disease / Autosomal dominant polycystic kidney / Liver function tests / Medicine / Health / Hepatology


January 22, 2013 IMPORTANT DRUG WARNING Potential Risk of Liver Injury with Use of SAMSCA® (tolvaptan) Dear Healthcare Provider, Otsuka would like to inform you of significant liver injury associated with the use of SAM
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City

Rockville / /

Company

Medical Affairs Otsuka America Pharmaceutical Inc. / Chapman AB / Alteon Inc. / /

Event

FDA Phase / /

IndustryTerm

https /

MedicalCondition

observed liver injury / chronic hyponatremia / fatal liver injury / ADPKD / hypervolemic hyponatremia / significant liver injury / cirrhosis / Industry Drug-Induced Liver Injury / Dominant Polycystic Kidney Disease / hepatic injury / hyponatremia / fatigue / Liver Injury / euvolemic hyponatremia / liver disease / /

Organization

FDA / also be mailed using the MedWatch form FDA / /

Person

Dario Mirski / /

/

Position

Vice President / Gansevoort RT / Krasa HB / /

Product

FS / SAMSCA / /

ProvinceOrState

Maryland / /

Technology

pdf / /

URL

http /

SocialTag