An antibiotic commonly used to treat several infections poses a risk for acute respiratory failure among healthy adolescents and young adults, according to a peer-reviewed study published on Nov. 24 in the JAMA Network Open journal.
The study focused on trimethoprim-sulfamethoxazole (TMP-SMX), a combination antibiotic. TMP-SMX is used to treat pneumonia and acts as a first- or second-line treatment for multiple other ailments, such as skin and urinary tract infections.
Researchers looked at data of individuals between 10 and 25 years of age from Ontario, Canada, to determine whether the use of TMP-SMX was associated with a higher risk of acute respiratory failure within 30 days of taking the medication compared with two other antibiotics—amoxicillin and cephalosporins.
One analysis compared 44,801 individuals who received TMP-SMX against 530,417 amoxicillin recipients, and the other compared 51,197 people who got TMP-SMX with 197,039 recipients of cephalosporins.
Among those who took TMP-SMX, a 30-day hospital visit with acute respiratory failure was reported in 0.03 percent of recipients. This was higher than the 0.01 percent hospital visit rate reported for each of the amoxicillin and cephalosporin groups.
“Results were consistent in multiple sensitivity analyses and when using an alternative study design,” the study said.
The analysis “supported and reinforced the 2019 FDA safety warning and label change regarding a potential association between TMP-SMX and acute respiratory failure in healthy adolescents and young adults,” it added.
“Our findings confirmed and extended previous evidence, including over 19 case reports linking TMP-SMX to acute respiratory failure in adolescents and young adults. Notably, many of the cases in these reports required invasive ventilation or lung transplants, and respiratory issues often persisted after discontinuing the drug, sometimes leading to death.”
The study was supported by the Institute for Clinical Evaluative Sciences (ICES), Western site, in Ontario. ICES receives grants from various groups, including government entities. The study also received funding from the Canadian Institutes of Health Research.
None of the authors in the study reported conflicts of interest.
In 2021, the U.S. Food and Drug Administration added warnings regarding the risk of acute respiratory failure to the labels of multiple TMP-SMX products, according to a report from the American Academy of Pediatrics.
“The updated labeling 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,” it said.
The new labeling applied to TMP-SMX products sold under various brand names—Septra and Septra DS tablets, Bactrim and Bactrim DS tablets, and Bactrim injection and pediatric suspension.
TMP-SMX Side Effects, Antibiotic Resistance
According to a 2022 paper published in the National Library of Medicine journal, TMP-SMX has been approved by the FDA for treating conditions such as acute infective exacerbation of chronic bronchitis, urinary tract infections, and traveler’s diarrhea.
The antibiotic is also used for treating conditions such as tuberculosis, malaria, acne vulgaris, pertussis, and listeria, it said.
Common adverse effects include rashes, photosensitivity, fatigue, loss of appetite, nausea, swollen tongue, dizziness, and insomnia, according to the paper. More serious effects include renal failure, various types of anemia, and pancreatitis.
The recent study on the TMP-SMX’s acute respiratory failure risk comes amid concerns about the excessive use of antibiotics and the spread of antibiotic-resistant pathogens.
A November 2024 study found that between 2016 and 2023, the consumption of antibiotics in 67 nations jumped 16.3 percent.
While antibiotic use was temporarily disrupted during the COVID-19 pandemic, “global consumption has rebounded quickly and continues to rise at an alarming rate,” Dr. Eili Klein, lead author of the study, said in a statement.
Even the excessive use of non-antibiotic medications can lead to antibiotic resistance in microbes.
A study published in the journal Nature on Aug. 25 suggested that ibuprofen and acetaminophen, two of the most commonly used non-antibiotic drugs in the United States, may be fueling antibiotic resistance in the United States.
