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Hepatotoxicity / Ezetimibe / Jaundice / Cirrhosis / Placebo / Mipomersen / Niacin / Elevated transaminases / Alefacept / Medicine / Hepatology / Liver function tests


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Document Date: 2015-03-03 10:30:18


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Company

SUSPECTED ADVERSE REACTIONS / Alteon Inc. / Genzyme Corporation / /

Event

FDA Phase / /

IndustryTerm

certified healthcare providers / magnetic resonance imaging / administration site / Hypertension Treatment / imaging / drug products / mg/mL solution / /

MedicalCondition

proteinuria / abdominal pain / neoplasms / active skin disease / glomerular nephritis / influenza-like illness / disease / Injection site pruritus / headache / arthralgia / Injection site reactions* Fatigue Influenza / chills / Carcinogenesis / progressive liver disease / nausea / high risk hypercholesterolemia / cirrhosis / active liver disease / high-risk hypercholesterolemia / hyperlipidemia / Injection site rash / erythema / fever / lethargy / pain / vomiting / fatigue / injury / Injection site inflammation / angioedema / skin infections / Nausea Vomiting Abdominal pain General disorders / coronary artery disease / local erythema / psoriasis / hypersensitivity / Angina / familial hypercholesterolemia / advanced liver disease / inflammation / sunburns / pruritus / liver disease / Injection site erythema / heterozygous familial hypercholesterolemia / hypercholesterolemia / /

MedicalTreatment

apheresis / /

Organization

DOSAGE AND ADMINISTRATION / FDA / /

/

Position

Nausea Vomiting Abdominal pain General / General / /

Product

Injection Site Reactions Injection / acetaminophen / Subcutaneous Injection / simvastatin / reactions / HoFH / KYNAMRO / 800FDA-1088 / /

Technology

Pharmacokinetics / magnetic resonance imaging / antibodies / Pharmacodynamics / MRI / /

URL

www.KynamroREMS.com / www.fda.gov/medwatch / /

SocialTag