From: Adverse drug reactions monitoring: prospects and impending challenges for pharmacovigilance
Marketed drug | Dosage form | Banned date | Reasons | Death occurred | Ref |
---|---|---|---|---|---|
Terfenadine (Seldane) | Tablets | February 1998 | Irregular heartbeat, stomach pain, light coloured stools, yellowing of eyes or skin, fainting, dizziness, abdominal discomfort, dry skin or itchiness, prolongation of QT interval, headache, benign prostatic hypertrophy, acute hepatitis, cholestatic hepatitis, jaundice, hepatic dysfunction | 0.9-1.2% | (Ito et al.2010) |
Mibefradil (Posicor) | Tablets | June 1998 | Leg edema, hypertension, chronic angina, rhinitis, leg edema, heart stroke, headache, abdominal pain, light headedness, dyspepsia | 123 death in 1Â year | (Chyka et al.2007) |
Astemizole (Hismanal) | Tablets, capsules | July 1999 | Heart problems, death, cardiac arrest, QT prolongation, Torsades de pointes, ventricular arrhythmias, cardiac arrhythmias, bradycardia, hypotension | 1-2% | (Minino et al.2002) |
Cisapride (Populsid) | Tablets, oral suspension, capsules, medi-melt tablets, injections | January 2000 | Fast heartbeat, convulsions, irregular heartbeat, QT prolongations, torsades de pointes, cardiac arrest, sudden death renal failure, ventricular arrhythmias | 80 deaths during clinical trial | (Solomon et al.2004) |
Rofecoxib | Tablets | November 2007 | increased arrhythmias, abdominal pain, tenderness, or discomfort, nausea, blood while vomiting, bloody, black, or tarry stools, unexplained weight gain, swelling or water retention, fatigue or lethargy, skin rash, itching, yellowing of skin or eyes, flu-like symptoms, or unusual bruising or bleeding. | 2-3% |