Given the available data from the literature on acute respiratory toxicity, including acute respiratory distress syndrome, as well as spontaneous reports with some cases of close temporal relationship, positive recall, and given a plausible mechanism of action, PRAC reviews the causal relationship between hydrochlorothiazide/spironolactone and acute respiratory distress syndrome, and medical professionals should be warned about acute respiratory toxicity. PRAC concluded that information about products containing hydrochlorothiazide/spironolactone should be changed accordingly.

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