propylthiouracil
Fuentes regulatorias consultadas
Indicaciones aprobadas
- Enfermedad de Graves o bocio multinodular tóxico cuando metimazol no se tolera y yodo radiactivo o cirugía no son adecuados; preparación para tiroidectomía o radioyodo en esas circunstancias.
Contraindicaciones
Absolutas
- Hipersensibilidad al propiltiouracilo o componentes.
Advertencias clínicas
- Advertencia destacada (boxed warning) · Advertencia grave: puede causar lesión hepática aguda, insuficiencia hepática, trasplante o muerte. Resérvalo para intolerancia a metimazol o cuando cirugía/radioyodo no sean adecuados; suspende ante síntomas hepáticos. — FDA, set_id 53c5f586-3e72-479d-89ba-379683c8f6ba
- Advertencia mayor · Puede causar agranulocitosis. Ante fiebre, odinofagia o infección, suspende y realiza hemograma urgente. También se han descrito vasculitis y lupus farmacológico. — FDA, set_id 53c5f586-3e72-479d-89ba-379683c8f6ba
Interacciones medicamentosas
- ModeradaAnticoagulantes orales
Mecanismo: Los cambios del estado tiroideo pueden modificar la respuesta anticoagulante.
Recomendación: Controla INR y ajusta el anticoagulante al iniciar, titular o suspender.
FDA, set_id 53c5f586-3e72-479d-89ba-379683c8f6ba
Eventos adversos
Comunes (≥1%)
Erupción, prurito, náuseas, vómitos, artralgia y alteración del gusto
Raros pero graves
Insuficiencia hepática, agranulocitosis, anemia aplásica y vasculitis ANCA
Embarazo y lactancia
Puede ser el antitiroideo elegido cuando se necesita tratamiento durante o justo antes del primer trimestre; usa la dosis mínima eficaz y reevalúa después. Pasa a la leche y requiere decisión clínica y vigilancia tiroidea del lactante.
Bibliografía reciente (PubMed)
Drug-induced vasculitis (DIV) is a rare form of vasculitis related to the use of various drugs. DIV primarily affects small to medium size vessels, but it can potentially involve vessels of any size. Differentiating between primary systemic vasculitis and DIV can be challenging; however, it is crucial, so that the offending agent can be discontinued promptly. The clinical phenotype of DIV is protean and depends on the size of the affected vessels. It ranges from arthralgias, to an isolated cutaneous rash, to severe single or multi-organ involvement. While withdrawal of the offending drug is the most important step in management, a significant number of patients require immunosuppressive therapy for varying periods of time. DIV can affect any vascular bed size, leading to protean vasculitic syndromes. Increased awareness among general practitioners, specialty, and subspecialty physicians is crucial for early recognition, and withdrawal of drug for better outcomes.
Hyperthyroidism caused by Graves' disease (GD) is a relatively rare disease in children. Treatment options are the same as in adults - antithyroid drugs (ATD), radioactive iodine (RAI) or thyroid surgery, but the risks and benefits of each modality are different. The European Thyroid Association guideline provides new recommendations for the management of pediatric GD with and without orbitopathy. Clinicians should be alert that GD may present with behavioral changes or declining academic performance in children. Measurement of serum TSH receptor antibodies is recommended for all pediatric patients with hyperthyroidism. Management recommendations include the first-line use of a prolonged course of methimazole/carbimazole ATD treatment (3 years or more), a preference for dose titration instead of block and replace ATD, and to avoid propylthiouracil use. Where definitive treatment is required either total thyroidectomy or RAI is recommended, aiming for complete thyroid ablation with a personalized RAI activity. We recommend avoiding RAI in children under 10 years of age but favor surgery in patients with large goiter. Pediatric endocrinologists should be involved in all cases.
The purpose of this meta-analysis was to assess the safety of the anti-thyroid drugs (ATDs) propylthiouracil (PTU) and methimazole (MMI) in the treatment of hyperthyroidism during pregnancy. From inception until June 2, 2022, all available studies were searched in PubMed, Web of Science, Cochrane, EBSCO, Embase, Scopus, and CNKI. Thirteen articles satisfying the inclusion criteria were examined. Our meta-analysis indicated that pregnant women treated with MMI had a higher risk of congenital anomalies than those treated with PTU (OR 0.80, 95%CI 0.69-0.92, P = 0.002, I2 = 41.9%). Shifting between MMI and PTU during pregnancy did not reduce the risk of birth defects compared to PTU alone (OR 1.18, CI 1.00 to 1.40, P = 0.061, I2 = 0.0%). There were no statistically significant differences in hepatotoxicity (OR 1.54, 95%CI 0.77-3.09, P = 0.221, I2 = 0.0%) or miscarriage (OR 0.89, 95%CI 0.72-1.11, P = 0.310, I2 = 0.0%) between PTU and MMI exposure. The study confirmed propylthiouracil is a safer alternative to methimazole for treating hyperthyroidism in pregnant women, and it is appropriate to treat maternal thyroid disease with PTU during the first trimester of pregnancy. However, it is not clear whether switching between propylthiouracil and methimazole is a better option than treating PTU alone during pregnancy. Further studies on this matter may be needed to develop new evidence-based guidelines for the treatment of pregnant women with hyperthyroidism.