Risk signals mining of ribavirin and interferon-alpha based on US FDA Adverse Event Reporting System

Objective To identify which induced the symptoms/signs and laboratory abnormal findings occurred in patients with novel coronavirus pneumonia, by disease itself or by ribavirin and interferon-alpha treatments, through mining the adverse events (AEs) signals of the 2 antivirus agents. Methods According to the symptoms/signs and laboratory abnormal findings of novel coronavirus pneumonia mentioned in the literature and "Diagnosis and Treatment scheme of Novel Coronavirus Pneumonia (trial version 5)" , AEs in this study were selected. Related data were collected from the U.S. FDA Adverse Events Reporting System (FARES) from Jan 1, 2004 to Dec 31, 2019, and the reporting odds ratio (ROR) method was used for signals detection for the above-mentioned 2 drugs. Results A total of 7 582 463 AEs related to drugs were reported in the FAERS database, of which 31 775 related to ribavirin and 2 345 related to interferon-alpha. The results showed that AEs related to ribavirin in respiratory, thoracic, and mediastinal disorders were nasal congestion, cough, laryngeal pain, pharyngeal oedema, productive cough, and dyspnoea; AEs related to interferon-alpha were laryngeal pain and haemoptysis. In other system organ class, AEs related to above 2 drugs were pyrexia, feeling cold, pyrexia, nausea, vomiting, diarrhoea, headache, arthralgia, myalgia, and rash. AEs of laboratory abnormal results related to ribavirin were white blood cell/platelet count decrease and aspartate/alanine aminotransferase increase; AEs related to interferon-alpha were white blood cell/platelet count decrease, aspartate/alanine aminotransferase increase, and lymphocyte count decrease. Conclusion Some AEs induced by ribavirin and interferon-alpha were similar to symptoms/signs and laboratory abnormal findings of novel coronavirus pneumonia, which should be distinguished in the clinical practice. Key words: Coronavirus infections; Ribavirin; Interferon-alpha; Adverse drug reaction reporting systems; Data mining