Drug, Healthcare and Patient Safety (Oct 2019)
Safety And Tolerability Of Extended-Release Guaifenesin In Patients With Cough, Thickened Mucus And Chest Congestion Associated With Upper Respiratory Tract Infection
Abstract
Sanjay Tripathi,1 Ashish Nikhare,2 Gaurav Sharma,3 Tim Shea,4 Helmut Albrecht5 1Department of Pulmonary Medicine, Sheth LG General Hospital & AMC MET Medical College, Ahmedabad, India; 2Department of Pulmonology, Lata Mangeshkar Hospital, Nagpur, India; 3Regional Medical Affairs (South of Asia), Reckitt Benckiser, Haryana, India; 4Global Medical - Respiratory, Reckitt Benckiser, Parsippany, NJ, USA; 5Department of Cellular Biology & Pharmacology, Herbert Wertheim College of Medicine, Florida International University, Miami, FL, USACorrespondence: Tim SheaReckitt Benckiser, 399 Interpace Parkway, Parsippany, NJ 07054, USATel +1 973 404 2883Fax +1 201-573-6325Email [email protected]: An extended-release (ER) formulation of the expectorant guaifenesin has recently been launched in India for the treatment of productive cough accompanied by mucus (phlegm). Although the safety profile of ER guaifenesin marketed in the USA is well documented, there were limited safety data available in the Indian population. The aim of this study was to further elucidate the safety profile of ER guaifenesin in patients with acute upper respiratory tract infection (URTI).Patients and methods: A prospective, post-marketing surveillance study enrolled 552 adults with cough, thickened mucus and chest congestion due to URTI, who took ER guaifenesin 1200 mg (Mucinex®, Reckitt Benckiser; two 600 mg tablets) every 12 hrs for 7 days. Adverse events (AEs) were recorded and questionnaires administered to patients and investigators.Results: A total of 29 treatment-emergent AEs were recorded in 28/552 patients, including gastrointestinal (n = 11), nervous system (n = 8), psychiatric (n = 3), respiratory, thoracic and mediastinal (n = 2), skin and subcutaneous tissue (n = 2), and general disorders (n = 3). All AEs were mild in severity and no serious AEs or deaths occurred. The majority of both patients and investigators were either satisfied or very satisfied with improvements in treatment outcomes.Conclusion: This study found that ER guaifenesin was well tolerated and had a favorable safety profile in otherwise healthy patients suffering from symptoms of cough, thickened mucus and chest congestion associated with URTI. Registered trial NCT03725085 (ClinicalTrials.gov) and CTRI/2014/07/004730 (ctri.nic.in).Keywords: expectorant, guaifenesin, Mucinex, post-marketing surveillance, safety profile, satisfaction
