Table 3

Count of case reports of selected withdrawn drug products submitted to EudraVigilance up to 30 June 2012

Drug name	MedDRA level	Term	Total
Rofecoxib	PT	Myocardial infarction	6711
Thioridazine	HLGT	Cardiac arrhythmias	179
Thioridazine	PT	Sudden death	28
Valdecoxib*	SOC	Skin and subcutaneous tissue disorders	317
Valdecoxib*	SOC	Cardiac disorders	313
Rosiglitazone*	SOC	Cardiac disorders	10 834
Sibutramine	PT	Blood pressure increased	69
Sibutramine	PT	Heart rate increased	23
Orciprenaline	HLGT	Cardiac arrhythmias	15
Benfluorex	HLGT	Cardiac valve disorders	3439
Benfluorex	PT	Pulmonary hypertension	181
Clobutinol	HLGT	Cardiac arrhythmias	14
Buflomedil	HLGT	Cardiac arrhythmias	36
	HLGT	Fatal outcomes†	14
	HLGT	Seizures (including subtypes)	35
Veralipride	HLGT	Anxiety disorders and symptoms	142
Veralipride	HLT	Depressive disorders	221
Rimonabant*	SOC	Psychiatric disorders	918
Rimonabant*	PT	Depression	545
Carisoprodol	HLGT	Mental impairment disorders	18
Carisoprodol	HLGT	Movement disorders (including parkinsonism)	15
Aceprometazine+Acepromazine+ Clorazepate	HLGT	Fatal outcomes	3
Dextropropoxyphene	HLGT	Fatal outcomes†	55
Dextropropoxyphene	HLGT	Overdoses	91
Nefazodone	HLGT	Hepatic and hepatobiliary disorders	16
Ximelagatran/melagatran	No results were returned
Lumiracoxib	HLGT	Hepatic and hepatobiliary disorders	92
Sitaxentan*	PT	Hepatitis	8
Sitaxentan*	PT	Hepatic failure	6
Bufexamac	SOC	Immune systems disorders	10

*Centrally authorised drug products. Information available on: http://www.adrreports.eu. 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.