Serious adverse drug reaction (sales-pre/post FDA meeting) Year of initial threat # of affected Pts (year of 1st report) Legal fines to companies Regulatory and Congressional hearing Criminal findings against corporations (and employees, if any)
Epoetin ($5.4 billion/$1 billion) 2007 2007 Not Available (2003) $610 million;
$95 million[@129271; @129272]
2004, 2006, 2007, 2008, 2010, 2011 None
Darbepoetin ($4.1 billion/$1.7 billion) 2007 2007 Not Available (2003) $610 million;
$95 million[@129271; @129272]
2004, 2006, 2007, 2008, 2010, 2011 2012: Amgen plead guilty to one criminal count of illegally introducing a misbranded drug and providing false information (for darbepoetin) into commerce. ($150 million fine).[@129271]
Rosiglitazone
($3 billion/$0.2 billion) 2007
1999 47,000 (2007)[@129285] 2011 GlaxoSmithKline set aside $3.4 billion to pay patients to settle individual lawsuits for injury[@129273] 2007, 2010, 2013 2012: GSK pled guilty to federal and charges of failing to report clinical data. ($3 billion in Federal penalties and $319 million for state penalties).[@129273]
Rofecoxib ($2.5 billion/ 2004, withdrawn in 2004) 2001, 2001, 2001 (three persons) 88,000- 140,000 (2005) Merck paid $4.85 billion (to patients for injuries).[@129185] 2004,2005 2011: Merck pled guilty to criminal misdemeanor of illegal promotional activity ($321 million fine).[@129300]
Fenfluramine-phentermine ($0.3 billion 1996/ drug withdrawn 1997) 1996 (two cli-nicians) 300,000 (1996) Wyeth paid $22 billion (to patients for injuries)[@129284] 2000 None
Benfluorex ($500 million 2008/drug withdrawn in 2009) 2007 2,000 deaths; 6,500 injured patients (2010) Servier paid $146 million- patients
$3.2 million and $0.5 million to the ANSM, the French pharmaceutical regulatory agency[@129214]
2011, 2021 (French courts) 2021: Manslaughter and criminal deceit- Servier and former Servier executive (four-year suspended sentence). ($3.3 million fine against Servier)[@129299]
Gadodiamide ($0.54 billion/ $0.2 billion 2020) 2007 Not known (2006) General Electric $500 million (to patients) (reportedly) 2009 None
Atrazine (still sold) 2002 Not known (2002) Syngenta paid $105 million (to 105 counties to settle class action lawsuit related to public water contamination)[@129282] 2012, 2020 None
Ivermectin (no known sales numbers) 2004 5,552 dogs with toxicity (2004) No fines were paid by Fort Dodge Animal Health 2004,2005 None
Paroxetine - 2009 use returned to 2004 levels 2004 Many cases (1991) GlaxoSmithKline pain patients $3 billion[@129301] 2004 2012: GlaxoSmithKline pled guilty to a 3-count criminal information charge, including one count of misbranding paroxetine. (Criminal fine of $956 million)[@129301]
Risedronate (risedronate) 2002 Not known Not applicable 2005- UK None
Phenyl-propanolamine (drug withdrawn) ($200 million 1999/$0 in 2000) 2000 Not known Not available. Cases were settled privately. 2000 None
Articular surface hip replacements (US recall-2010) 2007 8,000 persons $4 billion to patients for faulty hip prostheses[@129280] 2011 (Australia); 2012 (FDA) None
Synthroid 2004 None reported $42 million (states) $98 million (class action settlement)[@129281; @129282] None None
Valdecoxib 2004 1,100 persons (2005) Pharmacia paid $745 million (personal injury claims settlement). Also paid $1 billion in civil settlement for False Claims Act violation.[@129295; @129302] 2005 2009: Pharmacia pled guilty to a federal violation of misbranding valdecoxib with the intent to defraud or mislead. Paid $1.3 billion in criminal fine.[@129302]