The Drug-Induced Respiratory Disease Website and App

Frequency - Incidence

Incidence of respiratory adverse event(s) due to the specific drug as assessed by number of reported/published cases in the literature. Red digits in stars indicate: 0 = Very rare, questionable signal · 1 = < 10 cases · 2 = 10-50 cases · 3 = 50–100 cases · 4 = 100-200 cases · 5 = >200 cases

Evidence level/grade

Evidence level for respiratory adverse event(s) due to the specific drug as estimated using Hill’s (1965), Naranjo’s (1981), and Bégaud’s (1985) criteria applied to published cases. Blue digits in stars indicate: 0 = Questionable · 1 = Low · 2 = Moderate · 3 = Robust · 4 = Definite · 5 = Unquestionable, pathognomonic

XII.b

Valvular heart disease and/or dysfunction

Publications

Baufreton C, Bruneval P, Rousselet MC, Ennezat PV, Fouquet O, Giraud R, Banfi C

Fatal postoperative systemic pulmonary hypertension in benfluorex-induced valvular heart disease surgery: A case report.

Medicine. 2017;96(2):e4985

Szymanski C, Andréjak M, Peltier M, Maréchaux S, Tribouilloy C

Adverse effects of benfluorex on heart valves and pulmonary circulation.

Pharmacoepidemiology and drug safety. 2014;23(7):679-86

Andrejak M, Tribouilloy C

Drug-induced valvular heart disease: an update.

Archives of cardiovascular diseases. 2013;106(5):333-9

Derumeaux G, Ernande L, Serusclat A, Servan E, Bruckert E, Rousset H, Senn S, Van Gaal L, Picandet B, Gavini F, Moulin P, REGULATE trial investigators

Echocardiographic evidence for valvular toxicity of benfluorex: a double-blind randomised trial in patients with type 2 diabetes mellitus.

PloS one. 2012;7(6):e38273

Fournier A, Zureik M

Estimate of deaths due to valvular insufficiency attributable to the use of benfluorex in France.

Pharmacoepidemiology and drug safety. 2012;21(4):343-51

Tribouilloy C, Rusinaru D, Andréjak M

How can benfluorex-related heart valve disease be identified by echocardiography?

Archives of cardiovascular diseases. 2011;104(10):489-92

Le Ven F, Tribouilloy C, Habib G, Gueffet JP, Maréchaux S, Eicher JC, Blanchard-Lemoine B, Rousseau J, Hénon P, Jobic Y, Etienne Y

Valvular heart disease associated with benfluorex therapy: results from the French multicentre registry.

European journal of echocardiography : the journal of the Working Group on Echocardiography of the European Society of Cardiology. 2011;12(4):265-71