The FAERS Potential Signals of Serious Risks/New Safety Information listed Braftovi (encorafenib) and Tafinlar (dabrafenib) with Photosensitivity reactions as a potential signal on their January - March 2023 listing.
Analyzing the FAERS data up to 2023 Q3, the PRR for Photosensitivity reactions is less than 2 when comparing the drugs within their ATC group B-RAF SERINE-THREONINE KINASE (BRAF) INHIBITORS, but has a PRR greater than 2 in broader therapeutic classification groups.
ENCORAFENIB ATCs | PRR | MGPS | BCPN | ROR | CHISQ |
|---|---|---|---|---|---|
ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS | 3.38063 | 3.37293 | 50.21419 | 3.38516 | 18.39145 |
ANTINEOPLASTIC AGENTS | 3.10679 | 3.09998 | 47.7317 | 3.11591 | 15.68629 |
PROTEIN KINASE INHIBITORS | 2.18027 | 2.17646 | 44.73107 | 2.19245 | 7.03856 |
B-RAF SERINE-THREONINE KINASE (BRAF) INHIBITORS | 0.21495 | 0.21749 | 38.25421 | 0.19028 | 36.55911 |
DABRAFENIB ATCs | PRR | MGPS | BCPN | ROR | CHISQ |
|---|---|---|---|---|---|
ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS | 2.841 | 2.83599 | 53.54547 | 2.85124 | 38.14619 |
ANTINEOPLASTIC AGENTS | 2.61087 | 2.60649 | 51.06298 | 2.63132 | 31.87113 |
PROTEIN KINASE INHIBITORS | 1.83225 | 1.82999 | 48.06236 | 1.85774 | 12.26312 |
B-RAF SERINE-THREONINE KINASE (BRAF) INHIBITORS | 0.18064 | 0.18287 | 41.5855 | 0.10094 | 230.18509 |
Photosensitivity reaction is included in 2 SMQs (Hypersensitivity and Systemic lupus erythematosus) under the broad scope category. No other adverse events were reported for ENCORAFENIB, and one was reported for DABRAFENIB under the HLT Photosensitivity and photodermatosis conditions. Further analysis is required to confirm the potential signal.
Comments