Influence of regulatory measures on the rate of spontaneous adverse drug reaction reporting in Italy

Drug Safety

Volumn 31, Issue 7, 2008, Pages 609-616

  Motola, Domenico ^a   Vargiu, Antonio ^a   Leone, Roberto ^b   Conforti, Anita ^b   Moretti, Ugo ^b   Vaccheri, Alberto ^a   Velo, Giampaolo ^b   Montanaro, Nicola ^a  

^a UNIVERSITY OF BOLOGNA   (Italy)

^b Clinical Pharmacology Unit   (Italy)

Author keywords

ACE inhibitors, adverse reactions; Adverse drug reactions; Adverse drug reactions incidence; Cyclo oxygenase 2 inhibitors, adverse reactions; HMG CoA reductase inhibitors, adverse reactions; Legislation; Nimesulide, adverse reactions; Regulatory process

Indexed keywords

ANGIOTENSIN RECEPTOR ANTAGONIST; ATORVASTATIN; CAPTOPRIL; CERIVASTATIN; CYCLOOXYGENASE 2 INHIBITOR; DIPEPTIDYL CARBOXYPEPTIDASE INHIBITOR; ENALAPRIL; FLUINDOSTATIN; FOSINOPRIL; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR; LISINOPRIL; NAPROXEN; NIMESULIDE; PRAVASTATIN; RAMIPRIL; ROFECOXIB; SIMVASTATIN; VALDECOXIB;

ACUTE KIDNEY FAILURE; ANGIONEUROTIC EDEMA; ARTHRALGIA; ARTICLE; CARDIOVASCULAR DISEASE; CLINICAL TRIAL; CONTROLLED STUDY; COUGHING; DRUG MARKETING; DRUG SURVEILLANCE PROGRAM; DRUG USE; DRUG WITHDRAWAL; GASTROINTESTINAL DISEASE; HEART FAILURE; HUMAN; HYPERTENSION; ITALY; LIVER TOXICITY; MONOTHERAPY; MUSCULOSKELETAL DISEASE; OSTEOARTHRITIS; PRIORITY JOURNAL; RHABDOMYOLYSIS; RISK ASSESSMENT; SKIN MANIFESTATION; UNSPECIFIED SIDE EFFECT;

ADVERSE DRUG REACTION REPORTING SYSTEMS; ANGIOTENSIN-CONVERTING ENZYME INHIBITORS; CARDIOVASCULAR DISEASES; COUGH; CYCLOOXYGENASE 2 INHIBITORS; HUMANS; HYDROXYMETHYLGLUTARYL-COA REDUCTASE INHIBITORS; ITALY; LACTONES; LIVER; RHABDOMYOLYSIS; SULFONAMIDES; SULFONES;

EID: 45549100121     PISSN: 01145916     EISSN: None     Source Type: Journal    
DOI: 10.2165/00002018-200831070-00006     Document Type: Article

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