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

XVII.i

Mycobacterium bovis/BCG infection

Risk increases in naturally or iatrogenically immunosuppressed individuals (PMID 12856232). Can be fatal

Publications

Saldaña NG, Ranero ARC, Trujillo DMG, Garza EA, Tortoriello AIQ, Ruiz BV, Jurado RR, Olguín HJ, Silva ML

Osteitis secondary to BCG vaccine in immunocompetent patients: Three case reports.

Medicine. 2019;98(1):e13871

Rermruay R, Rungmaitree S, Chatpornvorarux S, Brukesawan C, Wittawatmongkol O, Lapphra K, Phongsamart W, Kongstan N, Khumcha B, Chokephaibulkit K

Clinical features and outcomes of Bacille Calmette-Guérin (BCG)-induced diseases following neonatal BCG Tokyo-172 strain immunization.

Vaccine. 2018;36(28):4046-4053

Zhou Q, Hui X, Ying W, Hou J, Wang W, Liu D, Wang Y, Yu Y, Wang J, Sun J, Zhang Q, Wang X

A Cohort of 169 Chronic Granulomatous Disease Patients Exposed to BCG Vaccination: a Retrospective Study from a Single Center in Shanghai, China (2004-2017).

Journal of clinical immunology. 2018;38(3):260-272

Sellami K, Amouri M, Kmiha S, Bahloul E, Aloulou H, Sfaihi L, Guirat R, Mseddi M, Kamoun T, Hachicha M, Turki H

Adverse Reactions Due to the Bacillus Calmette-Guerin Vaccine: Twenty Tunisian Cases.

Indian journal of dermatology. 2018;63(1):62-65

Lu S, Li T, Xi X, Chen Q, Liu X

Clinical and laboratory observation of Bacillus Calmette-Guérin infections.

International journal of clinical and experimental medicine. 2015;8(6):10099-104