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Table 3 Records of banned drugs

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 1 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%

(He et al.2005) (Solomon et al.2004)