Fingolimod, teriflunomide and cladribine for the treatment of multiple sclerosis in women of childbearing age: description of drug utilization and exposed pregnancies in Germany

Platzbecker, Katharina; Wentzell, Nadine; Kollhorst, Bianca; Haug, Ulrike

doi:10.1016/j.msard.2022.104184

Cited by 8 publications

(3 citation statements)

References 11 publications

(24 reference statements)

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“…Many diagnoses of MS occur during or before young adulthood; for example, one real-world study from Germany found that 65% of women receiving CladT for MS were aged < 40 years [ 95 ]. Pregnancy is a contraindication for CladT: women receiving the drug are required to avoid pregnancy until 6 months after the last dose and male patients should ensure pregnancy does not occur in their partner during this time period [ 23 ].…”

Section: Adverse Events Of Special Interestmentioning

confidence: 99%

Expert Narrative Review of the Safety of Cladribine Tablets for the Management of Relapsing Multiple Sclerosis

Clavelou¹,

Castelnovo

Pourcher

et al. 2023

Neurol Ther

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Section: Adverse Events Of Special Interestmentioning

confidence: 99%

Expert Narrative Review of the Safety of Cladribine Tablets for the Management of Relapsing Multiple Sclerosis

Clavelou¹,

Castelnovo

Pourcher

et al. 2023

Neurol Ther

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“…We conducted all statistical analyses using the software SAS version 9.4. The analyses were planned beforehand and conducted in an analogous way for other drugs with teratogenic potential [ 23 ]. There were no data-driven changes to the analysis plan.…”

Section: Methodsmentioning

confidence: 99%

Use of isotretinoin among girls and women of childbearing age and occurrence of isotretinoin-exposed pregnancies in Germany: A population-based study

Reinold,

Kollhorst,

Wentzell

et al. 2024

PLoS Med

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Background Exposure to isotretinoin during pregnancy must be avoided due to its teratogenicity, but real-world data on its use are scarce. We aimed to describe (i) isotretinoin use in women of childbearing age in Germany; (ii) the occurrence of isotretinoin-exposed pregnancies; and (iii) malformations among children exposed in utero. Methods and findings Using observational data from the German Pharmacoepidemiological Research Database (GePaRD, claims data from approximately 20% of the German population), we conducted annual cross-sectional analyses to determine age-standardized prevalence of isotretinoin use between 2004 and 2019 among girls and women aged 13 to 49 years. In cohort analyses, we estimated the number of exposed pregnancies by assessing whether there was prescription supply overlapping the beginning of pregnancy (estimated supply was varied in sensitivity analyses) or a dispensation within the first 8 weeks of pregnancy. Data of live-born children classified as exposed in a critical period according to these criteria were reviewed to assess the presence of congenital malformations. The age-standardized prevalence of isotretinoin use per 1,000 girls and women increased from 1.20 (95% confidence interval [CI]: 1.16, 1.24) in 2004 to 1.96 (95% CI: 1.92, 2.01) in 2019. In the base case analysis, we identified 178 pregnancies exposed to isotretinoin, with the number per year doubling during the study period, and at least 45% of exposed pregnancies ended in an induced abortion. In sensitivity analyses, the number of exposed pregnancies ranged between 172 and 375. Among live-born children, 6 had major congenital malformations. The main limitation of this study was the lack of information on the prescribed dose, i.e., the supply had to be estimated based on the dispensed amount of isotretinoin. Conclusions Isotretinoin use among girls and women of childbearing age increased in Germany between 2004 and 2019, and there was a considerable number of pregnancies likely exposed to isotretinoin in a critical period. This highlights the importance of monitoring compliance with the existing risk minimization measures for isotretinoin in Germany.

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“…From a public health perspective, studies on the utilization of (possibly) teratogenic drugs in women of childbearing age based on data reflecting the real world settingsuch as our studyare of high importance and may reveal potential needs to improve risk minimization measures. Funded by the German Federal Institute for Drugs and Medical Devices we also conducted drug utilization studies on other teratogenic drugs (e.g., methotrexate, teriflunomide, fingolimod) [33,34]. To ensure comparability, we used a similar design for all these studies and only adapted it to consider specific characteristics of the respective drug (e.g.…”

Section: Strengths and Limitationsmentioning

confidence: 99%

Prescribing of endothelin receptor antagonists and riociguat in women of childbearing age in a large German claims database study

Amann

Wentzell

Kollhorst

et al. 2023

Reproductive Toxicology

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Fingolimod, teriflunomide and cladribine for the treatment of multiple sclerosis in women of childbearing age: description of drug utilization and exposed pregnancies in Germany

Cited by 8 publications

References 11 publications

Expert Narrative Review of the Safety of Cladribine Tablets for the Management of Relapsing Multiple Sclerosis

Expert Narrative Review of the Safety of Cladribine Tablets for the Management of Relapsing Multiple Sclerosis

Use of isotretinoin among girls and women of childbearing age and occurrence of isotretinoin-exposed pregnancies in Germany: A population-based study

Prescribing of endothelin receptor antagonists and riociguat in women of childbearing age in a large German claims database study

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