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Medicine / Bristol-Myers Squibb / Didanosine / Cyclopropanes / Adverse Event Reporting System / Reverse-transcriptase inhibitor / Ribavirin / Abacavir / Antiretroviral drug / Purines / Pharmacology / Pharmaceutical sciences


Department of Health and Human Services Public Health Service Food and Drug Administration Center for Drug Evaluation and Research Office of Surveillance and Epidemiology
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City

Reference / /

Company

AEs / Bristol Myers Squibb / /

Country

United States / /

Event

FDA Phase / /

IndustryTerm

blood products / treatment of HIV / /

MedicalCondition

Intra-uterine exposure Neutropenia / thrombocytosis / HIV / headache / Box Neonatal Disorder / lipodystrophy / hepatic adverse events / fatal and non-fatal pancreatitis / leukopenia / liver failure / PT headache / acquired lipodystrophy / neutropenia / abdominal pain / cirrhosis / stomatitis / fat redistribution syndrome / peripheral neuropathy / fatal lactic acidosis / Concomitant diseases / erythema multiforme / hyperlipemia / diarrhea / hepatitis / proximal renal tubular acidosis / allergic dermatitis / immune reconstitution syndrome / acute liver failure / Lipodystrophy / mild bronchitis / non-cirrhotic portal hypertension / Hypertriglyceridemia / neonatal disorder / optic neuritis / Postmarket Experience Abdominal Pain / neutropenia / candidiasis / symptomatic hyperlactatemia/lactic acidosis / AV block / Fever / rhabdomyolysis / Vomiting / lactic acidosis / portal hypertension / angioedema / pancreatitis / fatal hepatic failure / Kaposi sarcoma / infection / esophageal varices / noncirrhotic portal hypertension / lipodystrophy / non-cirrhotic portal hypertension / anemia / tuberculosis / /

MedicalTreatment

experimental therapy / multidrug therapy / HAART / polypharmacy / /

OperatingSystem

OSE / /

Organization

office of New Drugs / office of Pediatrics / office of Surveillance and Epidemiology / office of Pharmacovigilance / Research office of Surveillance and Epidemiology Date / Director office of Pediatric Therapeutics / Department of Health and Human Services Public Health Service Food and Drug Administration Center for Drug Evaluation / FDA / /

Person

Lisa L. Mathis / Robert M. Boucher / Kelly Cao / M. Dianne Murphy / Ethan D. Hausman / /

/

Position

Cao / PharmD Safety Evaluator Team Leader / General / Director Division of Pharmacovigilance / contractor / Associate Director / EXECUTIVE / Medical Officer / CONTENTS EXECUTIVE / Director Pediatric and Maternal Health Staff / /

Product

Videx EC / efavirenz / zidovudine / Videx / acetaminophen / gentamicin / allopurinol / omeprazole / isoniazid / fluconazole / azithromycin / amoxicillin / folic acid / ribavirin / abacavir / lamivudine / DIDANOSINE / ceftriaxone / stavudine / HIV-1 / /

ProgrammingLanguage

EC / /

Technology

AV / /

SocialTag