India has launched an extended-release (ER) formulation ofthe expectorant guaifenesin has for the treatment of productive coughaccompanied by mucus. There is evidence depicting the safety profile of ERguaifenesin in western countries, however, the data establishing is safety inIndia is still scarce. The current study is aimed to understand the safetyprofile of ER guaifenesin in patients with acute upper respiratory tractinfection (URTI).
Thisprospective study recruited 552 adults with cough, thickened mucus and chestcongestion due to URTI. They were administered with ER guaifenesin 1200 mgevery 12 hrs for 7 days. Patients were analysed for adverse events (AEs).Additionally, questionnaires were asked from both patients and researchersregarding effectivity of the drug.

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

Thus, the study concluded that ER guaifenesin is anefficacious and well tolerated agent with favourable safety profile in patientssuffering from symptoms of cough, thickened mucus and chest congestionassociated with URTI.

Source: Tripathi S, Nikhare A, Sharma G, Shea T, Albrecht H.Safety And Tolerability Of Extended-Release Guaifenesin In Patients With Cough,Thickened Mucus And Chest Congestion Associated With Upper Respiratory TractInfection. Drug Healthc Patient Saf. 2019;11:87-94. Available at:https://doi.org/10.2147/DHPS.S222109