OBJECTIVES

Pain in jaw is a physical discomfort in the jaw. It can be a debilitating condition that affects ability to eat and speak. Riociguat used to treat pulmonary arterial hypertension (PAH). This study aims to quantify the risk of pain in jaw associated with Riociguat using disproportionality analysis of USFDA Adverse event reporting System (FAERS).

METHODS

: An analysis was performed using publicly available FAERS data. Signal strength was calculated by Reporting odds ratios (RORs) and Proportional reporting ratios (PRRs) with 95% confidence intervals (CIs). A value of ROR lower limit >1 and PRR >2, minimum 3 cases and chi square <4 indicates an association between drug and the adverse events.

RESULTS

A total number of 19800 reports for pain in jaw has been reported in the FDA database, amongst which, 629(3.17%) reports were associated with Riociguat. Riociguat associated with pain in jaw was found to have a signal strength of ROR: 3.881(2.808-5.364) and PRR: 3.864(2.801-5.331). Riociguat without concomitant drugs associated with pain in jaw was found to have a signal strength of ROR: 26.5032 (24.440- 28.7395) and PRR: 25.485. The minimum and maximum age reported was found to be 15yrs and 85yrs respectively with a signal strength of ROR: 84.14;PRR:80.021 for pediatrics, ROR:23.383;PRR:22.408 for Adults and ROR: 24.487;PRR: 23.475 for geriatrics. Pain in Jaw was mostly reported in females (78.54%) compared to males (20.99%) with a signal strength of ROR: 17.528; PRR:16.962 and ROR:29.737;PRR:28.943 respectively.

CONCLUSIONS

: The present showed an associated between Riociguat and Pain in Jaw, while this adverse event is not listed in the pre-clinical trial or post-marketing data. Although a causal relation cannot be definitively proved, the number of cases reported suggests that there might be an association. Increased awareness of this risk among both prescribers and patients may help mitigate the number and severity of these adverse events.