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Antithyroid Drug Side Effects in the Population and in Pregnancy
Abstract
OBJECTIVE: Methimazole (MMI) and propylthiouracil (PTU) are both associated with birth defects and may also rarely be associated with agranulocytosis and liver failure. The frequency of these side effects when antithyroid drugs (ATDs) are used in the population in general or in pregnancy remains to be elucidated. DESIGN: All individuals registered as the parent of a live-born child in Denmark, 1973–2008, were identified (n = 2 299 952) and studied from 1995 through 2010 for the use of ATDs. Outcomes were agranulocytosis, liver failure, and birth defects in their offspring. To evaluate the frequency of these side effects associated with the use of ATDs in pregnancy, all live-born pregnancies (n = 830 680), 1996–2008, were identified in a subanalysis. RESULTS: In the population studied, 28 998 individuals redeemed prescriptions of ATDs (exposure in 2115 pregnancies), which was associated with 45 cases of agranulocytosis (one in pregnancy) and 10 cases of liver failure (one in pregnancy). This corresponded to 41 and 11 cases of agranulocytosis and liver failure per 5 million inhabitants during a 10-year period (agranulocytosis: 0.16% of ATDs exposed [MMI: 0.11% vs PTU: 0.27%, P = .02]; liver failure: 0.03% of ATDs exposed [MMI: 0.03% vs PTU: 0.05%, P = .4]). The majority (83%) developed the side effect within 3 months of ATD treatment and 25% during hyperthyroidism relapse. The use of ATDs in pregnancy was associated with birth defects in 3.4% of exposed children (44 cases per 5 million inhabitants per 10 y), and the frequency of birth defects after ATD exposure was 75 times higher than both maternal agranulocytosis and liver failure in pregnancy. CONCLUSIONS: In the Danish population in general, ATDs associated birth defects and agranulocytosis had similar frequencies and were more common than liver failure, whereas for the use of ATDs in pregnancy, birth defects were dominant. The burden of side effects to the use of ATDs can be reduced by restricting the use of ATDs in early pregnancy.
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“In the third study from Denmark, the frequency of agranulocytosis was 0.27% with PTU and 0.11% with MMI (129).”
From 2016 American Thyroid Association Guidelines for Diagnosis and Management of Hyperthyroidism and Other Causes of Thyrotoxicosis (2016) · cites this paper as [129]
In the citing paper
“Two studies were from Japan and one was from Denmark.In both countries the majority of patients are treated with MMI, so data are more limited for PTU-associated agranulocytosis.”
From 2016 American Thyroid Association Guidelines for Diagnosis and Management of Hyperthyroidism and Other Causes of Thyrotoxicosis (2016) · cites this paper as [129]
In the citing paper
“Three recent reports of large numbers of ATD-treated patients who developed hematologic complications provide information on risk factors, treatment, and outcomes (127-129).”
From 2016 American Thyroid Association Guidelines for Diagnosis and Management of Hyperthyroidism and Other Causes of Thyrotoxicosis (2016) · cites this paper as [129]
In the citing paper
“In the study from Denmark (129), hepatotoxic reactions were not classified as cholestatic or hepatocellular, but the frequency of ''liver failure'' was similar for MMI (0.03%) and PTU (0.03%).”
From 2016 American Thyroid Association Guidelines for Diagnosis and Management of Hyperthyroidism and Other Causes of Thyrotoxicosis (2016) · cites this paper as [129]
In the citing paper
“As in prior studies, the median duration of therapy prior to the development of agranulocytosis was 36 and 38 days for MMI and PTU, respectively.”
From 2016 American Thyroid Association Guidelines for Diagnosis and Management of Hyperthyroidism and Other Causes of Thyrotoxicosis (2016) · cites this paper as [129]
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Bezdíčka, M., Kleiblová, P., Soucek, J., Borecká, M., El‐Lababidi, E., Smrž, D., Rataj, M., Šumnı́k, Z., Malíková, J., & Souček, O. (2021) · HORMONES · doi:10.1007/s42000-021-00299-x · Cited by 2
Letter to the Editor: “Our Response to COVID-19 as Endocrinologists and Diabetologists”
Kobaly, K. N., Mandel, S. J., Cappola, A. R., & Kim, C. S. (2020) · The Journal of Clinical Endocrinology & Metabolism · doi:10.1210/clinem/dgaa212 · Cited by 2
“This is considered a serious side effect with a fatality rate of 4% 6 .”
BackgroundJacobson, S., Stetco, J.-R., Brown, R., & Garfield, N. (2025) · JCEM Case Reports · doi:10.1210/jcemcr/luaf013 · Cited by 1
Toxic Adenoma and Multinodular Toxic Goiter
Tonacchera, M., & Führer, D. (2017) · Endocrinology · doi:10.1007/978-3-319-29195-6_18-1 · Cited by 1
Vanderpump, M. P. J. (2021) · Oxford University Press eBooks · doi:10.1093/med/9780198851899.003.0001 · Cited by 1
Effects of Methimazole vs Propylthiouracil in Newborns: A Comparative Review
Bhagat, M., Singh, P., Sunkara, S. M., Abraham, M. T., Alverde, M. J. B., Mundla, S. R., Drijanski, A. M., Jobilal, A., Lakkimsetti, M., Nair, N., et al. (2023) · Cureus · doi:10.7759/cureus.41505 · Cited by 1
“Severe effects include agranulocytosis, hepatotoxicity, hypothyroidism, and teratogenicities like aplasia cutis, choanal atresia, craniofacial defects, and esophageal atresia [20-22].”
BackgroundConcomitant methimazole-induced agranulocytosis and cholestatic jaundice in a young woman
Alcorn, C., Subarajan, P., & Anderson, J. (2022) · BMJ Case Reports · doi:10.1136/bcr-2022-250113 · Cited by 1
Bolton, W. D., & Perkins, J. M. (2018) · Springer eBooks · doi:10.1007/978-3-319-99079-8_7 · Cited by 1
Radionuclide Therapies and Correlative Imaging
Parihar, A. S., & Mittra, E. (2023) · Wiley eBooks · doi:10.1002/9781119603627.ch32 · Cited by 1
Buschur, E., & Thung, S. (2023) · doi:10.1002/9781119636540.ch21 · Cited by 1
Advancements in Clinical Thyroidology in 2016
Brito, M. (2016) · US Endocrinology · doi:10.17925/use.2016.12.02.83
“It is clear that methimazole is associated with a rare embryopathy but recent information also indicates that PTU is associated with congenital abnormalities, although of less severity.(26) Therefore, it is best to avoid antithyroid drugs as much as possible in women who are planning pregnancy since it is likely they…”
Führer, D., & Scherbaum, W. A. (2017) · Der Diabetologe · doi:10.1007/s11428-017-0235-5
Thyroid dysfunction during pregnancy
Yim, C. H. (2018) · Journal of Korean Medical Association · doi:10.5124/jkma.2018.61.4.253
“그러나 대규모 연구에서 MMI에 비해서 PTU 에 의한 기형의 빈도가 낮고 경증일 뿐, MMI나 PTU 투여군 모두에서 태아기형이 발생된다고 알려졌다[31].”
InfluentialRISCOS E BENEFÍCIOS DO TRATAMENTO DO HIPERTIREOIDISMO GESTACIONAL: UMA ATUALIZAÇÃO
Carbone, B. L., Moro, I. M., Horiguchi, L., Antonio, L. J., Pereira, M. M., & Moura, M. V. (2018) · doi:10.5151/comusc2018-12
Tang, C. J., & Hennessey, J. V. (2020) · Springer eBooks · doi:10.1007/978-3-030-38976-5_8
Graves’ Hyperthyroidism in Pregnancy
Nguyen, C. T., & Mestman, J. H. (2021) · Elsevier eBooks · doi:10.1016/b978-0-323-76097-3.00023-5
Article Review: Present Perspectives of Hyperthyroidism During Pregnancy
Farman, M. S., Hamoode, R. H., & Sattar, D. A. (2022) · International Journal of Physiology · doi:10.37506/ijop.v10i1.3214
“Additionally, mothers who have been infected with HIV during pregnancy can give birth to or transmit TRAb in the newborn[63-64], resulting in fetal or neonatal Graves’s disease Central hypothyroidism, which is generally seen during pregnancy with normal serum thyroxine levels, results from higher levels of thyroxine i…”
BackgroundPredictive Value of TRAb in the Early Drug Treatment of GD
陶, 玥. (2021) · Advances in Clinical Medicine · doi:10.12677/acm.2021.1112862
Management of Thyroid Disorders Before Assisted and Spontaneous Pregnancies
Poppe, K. G., Veltri, F., & Unuane, D. (2022) · doi:10.1093/med/9780198870197.003.0171
Chng, C. L. (2018) · Springer eBooks · doi:10.1007/978-981-10-1124-5_2
Woman With Fatigue and Weight Loss
Holmes, T., Abramczyk, R., Shaffer, C., Berger, M., Gibbons, R. C., & Costantino, T. G. (2022) · Annals of Emergency Medicine · doi:10.1016/j.annemergmed.2021.11.010
Incidence, treatments, and outcomes of Graves’ disease in Thailand: a single-center studyPreprint
Kanokwongnuwat, W. (2022) · Research Square · doi:10.21203/rs.3.rs-1527901/v1
(2017) · Reactions Weekly · doi:10.1007/s40278-017-28335-9
Think Thyroid - Think Life: Pregnancy with Thyroid Disorders
(2016) · Chettinad Health City Medical Journal · doi:10.36503/chcmj5(3)-05
Li, J. H., Kasid, N., & Hennessey, J. V. (2019) · Springer eBooks · doi:10.1007/978-3-319-72102-6_22
Graves’ disease: A review in diagnosis and management
Dwisaputra, I. G. N. B. H., & Prabawa, I. M. Y. (2020) · Intisari Sains Medis · doi:10.15562/ism.v11i3.762
Thyroid Storm in Pregnancy: A Rare Case ReportPreprint
Khan, A. (2023) · Research Square · doi:10.21203/rs.3.rs-3586725/v1
Tang, C. J., & Hennessey, J. V. (2025) · Springer eBooks · doi:10.1007/978-3-031-86099-7_8
Ulfa, M. (2025) · COMSERVA Jurnal Penelitian dan Pengabdian Masyarakat · doi:10.59141/comserva.v5i3.3288
Metadata
- Authors
- Andersen, S. L., Olsen, J., & Laurberg, P.
- Affiliations
- Aalborg University Hospital (DK)
- Corresponding author
- Andersen, Stine Linding
- Venue
- The Journal of Clinical Endocrinology & Metabolism
- Publisher
- The Endocrine Society
- Published
- 2016-04
- Volume
- 101
- Issue
- 4
- Pages
- 1606-1614
- ISSN
- 0021-972X (ISSN-L)
- 1945-7197
- OpenAlex
- W2268312181
- Cited by
- 107
- References
- 44
- Citations by year
- 2026: 4 · 2025: 6 · 2023: 10 · 2022: 15 · 2021: 13 · 2020: 14 · 2019: 7 · 2018: 13 · 2017: 14 · 2016: 11
- FWCI
- 15.08
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- The Journal of Clinical Endocrinology & Metabolism (publishedVersion)
- PubMed (publishedVersion)
- VBN Forskningsportal (Aalborg Universitet) (submittedVersion)
- Funders
- Aalborg Universitet
- Aalborg Universitetshospital
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Thyroid Disorders and Treatments
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Pregnancy and Medication Impact
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
- Keywords
- antithyroid drugs, methimazole, propylthiouracil, pregnancy, congenital malformations, agranulocytosis, liver failure, adverse drug reactions, hyperthyroidism, drug safety, prenatal drug exposure, hyperthyroidism relapse, pregnancy registry
- MeSH terms
- Abnormalities, Drug-Induced, Adult, Agranulocytosis, Female, Humans, Hyperthyroidism, Middle Aged, Pregnancy, Pregnancy Complications, Prenatal Exposure Delayed Effects, Antithyroid Agents, Liver Failure, Young Adult
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