India has launched an extended-release (ER) formulation of the expectorant guaifenesin has for the treatment of productive cough accompanied by mucus. There is evidence depicting the safety profile of ER guaifenesin in western countries, however, the data establishing is safety in India is still scarce. The current study is aimed to understand the safety profile of ER guaifenesin in patients with acute upper respiratory tract infection (URTI).This prospective study recruited 552 adults with cough, thickened mucus and chest congestion due to URTI. They were administered with ER guaifenesin 1200 mg every 12 hrs for 7 days. Patients were analysed for adverse events (AEs). Additionally, questionnaires were asked from both patients and researchers regarding effectivity of the drug.

The study thus, recorded a total of 29 treatment-emergent AEs in 28 out of 552 patients. These AEs included gastrointestinal, nervous system, psychiatric, respiratory, thoracic and mediastinal, skin and subcutaneous tissue, and general disorders. All occurred AEs were mild in severity and no severe AEs or any death was reported. Furthermore, maximum proportion of patients and researchers were either satisfied or very satisfied with amelioration in treatment outcomes.

Thus, the study concluded that ER guaifenesin is an efficacious and well tolerated agent with favourable safety profile in patients suffering from symptoms of cough, thickened mucus and chest congestion associated with URTI.

Source: Drug Healthc Patient Saf. 2019;11:87-94. Available at: https://doi.org/10.2147/DHPS.S222109