Drugs that have been withdrawn
from the market due to patient risks
When drugs that have been approved
by the FDA are shown to cause unexpected and
dangerous conditions in patients, they can be
recalled and withdrawn from the market.
Usually the risks did not surface during the Phase III clinical trials and
only became apparent from wide-use patient
experience.
Drugs that are
now listed as dangerous drugs
include:
alosetron (2000) - withdrawn due to risk of fatal complications of constipation; reintroduced 2002 on a restricted basis
bextra (2005) - withdrawn due to risk of
cardiovascular events
cerivastatin (2001) - withdrawn due to risk of rhabdomyolysis
cisapride (2000s) - withdrawn in many countries due to risk of cardiac arrhythmias
diethylstilbestrol (1970s) - withdrawn due to risk of teratogenicity
duract (1998) - withdrawn due to risk of
hepatitis
Fen-phen - popular combination of fenfluramine and phentermine; phentermine remains on the market, dexfenfluramine & fenfluramine (1997) later withdrawn
lysergic acid diethylamide (LSD) (1950s-1960s), marketed as a psychiatric cure-all; withdrawn after it became widely used recreationally by hippies
methaqualone (1984) - withdrawn due to risk of addiction and overdose.
meridia (1998) - withdrawn do to link to 19
heart attack deaths
mibefradil (1998) - withdrawn due to dangerous interactions with other drugs
phenformin and buformin - withdrawn due to risk of lactic acidosis
rapacuronium (2001) - withdrawn in many countries due to risk of fatal bronchospasm
rofecoxib (Bextra) (2004) - withdrawn due to risk of myocardial infarction
terfenadine (1998) - withdrawn due to risk of cardiac arrhythmias; superseded by fexofenadine
thalidomide (1950s-1960s) - withdrawn due to risk of teratogenicity; returned to market as an anti-neoplastic drug under FDA orphan drug rules
ticrynafen (1982) - withdrawn due to risk of hepatitis
triazolam (1991) - withdrawn in the United Kingdom due to risk of psychiatric adverse drug reactions
troglitazone (2000) - withdrawn due to risk of hepatotoxicity; superseded by pioglitazone and rosiglitazone
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