Philippe Camus, M.D.

Dijon, France

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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

XLII.a

Alveolar hemorrhage (AH), diffuse AH (DAH)

It can be difficult to determine whether DAH is present in patients with hemoptysis and concomitant pulmonary infiltrates. E.g. PMID 23544289

Publications

Nour SM, Nour HA, Mehta JB, Roy TM, Byrd RP

Hemoptysis and respiratory failure following sildenafil use for pulmonary hypertension.

Tennessee medicine : journal of the Tennessee Medical Association 2013 Mar;106;34-5 — 2013 Mar — 34-5

Maxey DM, Ivy DD, Ogawa MT, Feinstein JA

Food and Drug Administration (FDA) postmarket reported side effects and adverse events associated with pulmonary hypertension therapy in pediatric patients.

Pediatric cardiology 2013 Oct;34;1628-36 — 2013 Oct — 1628-36

Pereira e Silva JL, Araujo Neto CA, Marchiori E

Pulmonary hemorrhage after the use of sildenafil.

Heart & lung : the journal of critical care 2012 Jul-Aug;41;407-8 — 2012 Jul-Aug — 407-8