Table 3

Count of case reports of selected withdrawn drug products submitted to EudraVigilance up to 30 June 2012

Drug nameMedDRA levelTermTotal
RofecoxibPTMyocardial infarction6711
ThioridazineHLGTCardiac arrhythmias179
PTSudden death28
Valdecoxib*SOCSkin and subcutaneous tissue disorders317
SOCCardiac disorders313
Rosiglitazone*SOCCardiac disorders10 834
SibutraminePTBlood pressure increased69
PTHeart rate increased23
OrciprenalineHLGTCardiac arrhythmias15
BenfluorexHLGTCardiac valve disorders3439
PTPulmonary hypertension181
ClobutinolHLGTCardiac arrhythmias14
BuflomedilHLGTCardiac arrhythmias36
HLGTFatal outcomes†14
HLGTSeizures (including subtypes)35
VeraliprideHLGTAnxiety disorders and symptoms142
HLTDepressive disorders221
Rimonabant*SOCPsychiatric disorders918
CarisoprodolHLGTMental impairment disorders18
HLGTMovement disorders (including parkinsonism)15
Aceprometazine+Acepromazine+ ClorazepateHLGTFatal outcomes3
DextropropoxypheneHLGTFatal outcomes†55
NefazodoneHLGTHepatic and hepatobiliary disorders16
Ximelagatran/melagatranNo results were returned
LumiracoxibHLGTHepatic and hepatobiliary disorders92
PTHepatic failure6
BufexamacSOCImmune systems disorders10
  • *Centrally authorised drug products. Information available on: Other information received by email from EMA.

  • †The original condition, preceding the fatal outcome is unknown, therefore, there is a possibility of duplicate reporting.

  • EMA, European Medicines Agency; HLGT, Higher Level Group Term; PT, preferred term; SOC, System Organ Class.