The FAERS Potential Signals of Serious Risks/New Safety Information listed Tepezza (teprotumumab-trbw) with Hearing impairment as a potential signal on their January - March 2023 listing.
Hearing impairment is included as an SMQ in MedDRA rather than as PT. Analyzing the FAERS data up to 2023 Q3, the PRR for PTs included Hearing impairment SMQ is more than 2 when comparing teprotumumab within its ATC groups (SELECTIVE IMMUNOSUPPRESSANTS, IMMUNOSUPPRESSANTS, and ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS).
TEPROTUMUMAB ATCs | Top 4 Hearing impairment SMQ PTs | PRR | MGPS | BCPN | ROR |
|---|---|---|---|---|---|
ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS | Hypoacusis | 33.29087 | 30.93415 | 55.09789 | 33.70671 |
IMMUNOSUPPRESSANTS | Hypoacusis | 31.9446 | 29.68614 | 53.58119 | 32.61059 |
SELECTIVE IMMUNOSUPPRESSANTS | Hypoacusis | 24.19301 | 22.5003 | 50.28364 | 25.60837 |
ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS | Tinnitus | 55.36077 | 51.45907 | 54.31544 | 56.53535 |
IMMUNOSUPPRESSANTS | Tinnitus | 55.35968 | 51.45806 | 52.73936 | 57.42017 |
SELECTIVE IMMUNOSUPPRESSANTS | Tinnitus | 47.10461 | 43.79548 | 49.27458 | 52.91666 |
ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS | Deafness | 33.85277 | 32.44858 | 53.48508 | 34.29684 |
IMMUNOSUPPRESSANTS | Deafness | 34.15648 | 32.73931 | 51.8961 | 34.94521 |
SELECTIVE IMMUNOSUPPRESSANTS | Deafness | 34.2 | 32.78097 | 48.19688 | 37.23641 |
ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS | Deafness permanent | 2035.302 | 1994.288 | 45.37538 | 11282.13 |
IMMUNOSUPPRESSANTS | Deafness permanent | 1331.478 | 1304.654 | 44.41147 | 17962.45 |
SELECTIVE IMMUNOSUPPRESSANTS | Deafness permanent | 383.8798 | 376.1604 | 42.50833 | 9955.874 |
A few of the PTs included Hearing impairment SMQ are included in the EMA IME list. Further analysis is required to confirm the potential signal.
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