A Disproportionality Analysis of the Adverse Effect Profiles of Methimazole and Propylthiouracil in Patients with Hyperthyroidism Using the Japanese Adverse Drug Event Report Database
Authors' conclusion
This large-scale study confirmed that a variety of congenital malformations were identified as having significantly high RORs for MMI use, while diseases related to ANCA-associated vasculitis were specific to PTU.
Study context
- Population
- Patients with hyperthyroidism receiving antithyroid drugs, cases in the Japanese Adverse Drug Event Report (JADER) database; 9789 preferred terms for adverse events9,789 preferred terms (PTs) analysed
- Participants
- 3,271 vs 1,029
- Exposure
- MMI vs propylthiouracil (PTU)
- MMIn = 3,271
- PTUn = 1,029
- Outcome
- PTs with significantly higher RORs (>4-fold) for MMI vs PTU or for PTU vs MMI
Methodological detailsJapanese Adverse Drug Event Report (JADER) database, reporting odds ratios, prescription prevalence from NDB Open Data Japan
- Japanese Adverse Drug Event Report (JADER) database
- Reporting odds ratios
- Prescription prevalence from NDB Open Data Japan
Main finding
As reported in the abstract
- MMI vs PTU · agranulocytosis
- ROR fold 4.01; P < 0.0001
- MMI vs PTU · aplasia cutis congenita
- ROR fold 123.22; P < 0.0001
- MMI vs PTU · exomphalos
- ROR fold 22.17; P = 0.0002
- PTU vs MMI · anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis
- ROR 29.84; P < 0.0001
- PTU vs MMI · rapidly progressive glomerulonephritis
- ROR 6.44; P < 0.0001
- PTU vs MMI · pulmonary alveolar hemorrhage
- ROR 7.77; P < 0.0001
- PTs with significantly higher reporting odds ratios (RORs) (>4-fold) for MMI than PTU
- 8
- PTs with RORs for PTU >4 times those for MMI
- 19
Observational data: associations, not effects.
Further findings
Prescriptions in women of reproductive age (NDB Open Data Japan)
- PTU prescribed more frequently than MMI in women of reproductive age
Original publication
A Disproportionality Analysis of the Adverse Effect Profiles of Methimazole and Propylthiouracil in Patients with Hyperthyroidism Using the Japanese Adverse Drug Event Report Database. Thyroid. Published 19 May 2023. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →