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An event is serious (based on the ICH definition) when the patient outcome is:
* congenital anomaly
* other medically important event
A 25-year old woman developed acquired renal Fanconi syndrome during treatment with meropenem and amoxicillin/clavulanic acid for an extensively drug-resistant pulmonary tuberculosis (XDR-TB).
The woman, who had been intermittently treated for XDR-TB since 2006, presented for the treatment under different clinical protocol in 2015. She was started on IV meropenem 1.5g and oral amoxicillin/clavulanic acid [amoxicillin/clavulanate] 500/125mg, both every 8h along with concomitant linezolid, bedaquiline and clofazimine. Within one month after the start of the treatment, she developed mild hypophosphataemia. At three months, her urinalysis and renal function remained normal. After 98 days of the treatment, her sputum cultures became negative for TB. At 4 months, she developed a mild...
- Abadie ME, et al. Renal Fanconi syndrome with meropenem/amoxicillin-clavulanate during treatment of extensively drug-resistant tuberculosis. European Respiratory Journal 50: No. 6, 28 Dec 2017. Available from: URL: http://doi.org/10.1183/13993003.02023-2017 - USA