Regulatory anticipation of postmarket safety problems for novel medicines approved by the EMA between 2001 and 2010: a cross-sectional study

Pharmacoepidemiology and Drug Safety

Volumn 25, Issue 6, 2016, Pages 687-694

  Zeitoun, Jean David ^a,b,c   Lefèvre, Jérémie H ^b,d   Downing, Nicholas S ^e   Bergeron, Henri ^a,f   Ross, Joseph S ^e,g,h  

^a SCIENCES PO   (France)

^b HÔPITAL SAINT ANTOINE   (France)

^c GROUPE HOSPITALIER DIACONESSES CROIX SAINT SIMON   (France)

^d SORBONNE UNIVERSITÉ   (France)

^e YALE NEW HAVEN HOSPITAL   (United States)

^f CNRS   (France)

^g YALE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^h YALE UNIVERSITY   (United States)

Author keywords

drug approval; European Medicines Agency; government regulation; pharmacoepidemiology; prescription drugs; safety

Indexed keywords

17 METHYLNALTREXONE; ALEMTUZUMAB; ARIPIPRAZOLE; BEVACIZUMAB; CINACALCET; DAPTOMYCIN; DEFERASIROX; DENOSUMAB; DRONEDARONE; DRUG; EFALIZUMAB; ETRAVIRINE; FEBUXOSTAT; FONDAPARINUX; IMATINIB; LENALIDOMIDE; PALIFERMIN; PARECOXIB; PRASUGREL; RECOMBINANT BONE MORPHOGENETIC PROTEIN 2; RECOMBINANT INTERLEUKIN 1 RECEPTOR BLOCKING AGENT; RIMONABANT; ROMIPLOSTIM; SAXAGLIPTIN; TELITHROMYCIN; TIPRANAVIR; TOCILIZUMAB; UNINDEXED DRUG; VARENICLINE; VERNAKALANT;

ACUTE PANCREATITIS; ADVERSE DRUG REACTION; ALLERGIC REACTION; ARTICLE; BLEEDING; BRAIN HEMORRHAGE; CARDIOTOXICITY; CEREBROVASCULAR ACCIDENT; DEPRESSION; DIGESTIVE SYSTEM PERFORATION; DRUG APPROVAL; DRUG CARCINOGENICITY; DRUG HYPERSENSITIVITY; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; DRUG WITHDRAWAL; EOSINOPHILIA; EUROPEAN MEDICINES AGENCY; FEMUR FRACTURE; GASTROINTESTINAL HEMORRHAGE; GASTROINTESTINAL TOXICITY; HEART FAILURE; HEMATOLOGIC DISEASE; HUMAN; HYPOCALCEMIA; HYPOTENSION; IMMUNOPATHOLOGY; INFECTION; LIVER FAILURE; LIVER INJURY; LIVER TOXICITY; LOEFFLER PNEUMONIA; MALIGNANT NEOPLASTIC DISEASE; MEDICAL SOCIETY; MENTAL DISEASE; METABOLIC DISORDER; NEPHROTOXICITY; NEUROLOGIC DISEASE; PERIPHERAL NEUROPATHY; POSTOPERATIVE EDEMA; PREDICTIVE VALUE; PRIORITY JOURNAL; PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY; RISK FACTOR; SKIN TOXICITY; TERATOGENICITY; THROMBOEMBOLISM; THROMBOSIS; TRACHEOESOPHAGEAL FISTULA; UNSPECIFIED SIDE EFFECT;

EID: 84973493545     PISSN: 10538569     EISSN: 10991557     Source Type: Journal    
DOI: 10.1002/pds.3910     Document Type: Article

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