The Food and Drug Administration (FDA) approved revised labeling for Septra and Septra DS (double strength) tablets, Bactrim and Bactrim DS tablets and Bactrim injection and pediatric suspension.1 Labeling for other TMPSMX products is being updated with the new safety information. The updated includes new safety information on acute eosinophilic pneumonia, acute and delayed lung injury, interstitial lung disease and acute respiratory failure resulting in prolonged mechanical ventilation, extracorporeal membrane oxygenation (ECMO), lung transplantation or death.
The warnings come after a case series described severe acute respiratory failure related to TMP-SMX treatment in five previously healthy adolescents within days to weeks of TMP-SMX initiation.2 Four patients required prolonged ECMO, one underwent a heart and lung transplant, and two died. Four of the adolescents had been prescribed TMP-SMX for treatment of acne vulgaris, an unapproved indication. The mechanism of pulmonary toxicity related to TMP-SMX, particularly in previously healthy individuals,...
