scholarly journals Maximum Recommended Dosage of Lithium for Pregnant Women Based on a PBPK Model for Lithium Absorption

2012 ◽  
Vol 2012 ◽  
pp. 1-9 ◽  
Author(s):  
Scott Horton ◽  
Amalie Tuerk ◽  
Daniel Cook ◽  
Jiadi Cook ◽  
Prasad Dhurjati
Keyword(s):  
Bipolar Disorder ◽  
Birth Defects ◽  
Dosage Regimen ◽  
Pbpk Model ◽  
Lithium Concentration ◽  
Maximum Dosage ◽  
Lithium Therapy ◽  
Reproductive Age ◽  
Therapy Regimen ◽  
Class D

Treatment of bipolar disorder with lithium therapy during pregnancy is a medical challenge. Bipolar disorder is more prevalent in women and its onset is often concurrent with peak reproductive age. Treatment typically involves administration of the element lithium, which has been classified as a class D drug (legal to use during pregnancy, but may cause birth defects) and is one of only thirty known teratogenic drugs. There is no clear recommendation in the literature on the maximum acceptable dosage regimen for pregnant, bipolar women. We recommend a maximum dosage regimen based on a physiologically based pharmacokinetic (PBPK) model. The model simulates the concentration of lithium in the organs and tissues of a pregnant woman and her fetus. First, we modeled time-dependent lithium concentration profiles resulting from lithium therapy known to have caused birth defects. Next, we identified maximum and average fetal lithium concentrations during treatment. Then, we developed a lithium therapy regimen to maximize the concentration of lithium in the mother’s brain, while maintaining the fetal concentration low enough to reduce the risk of birth defects. This maximum dosage regimen suggested by the model was 400 mg lithium three times per day.

scholarly journals Risk of pre-term births and major birth defects resulting from paternal intake of COVID-19 medications prior to conception

2020 ◽  
Vol 13 (1) ◽  
Author(s):  
Silvia Rizzi ◽  
Maarten J. Wensink ◽  
Rune Lindahl-Jacobsen ◽  
Lu Tian ◽  
Ying Lu ◽  
...  
Keyword(s):  
Cohort Study ◽  
Birth Outcomes ◽  
Birth Defects ◽  
Sperm Quality ◽  
The Other ◽  
Reproductive Age ◽  
Adverse Birth Outcomes ◽  
Term Birth ◽  
Large Numbers ◽  
Term Births

Abstract Objective With the ongoing COVID-19 pandemic, large numbers of people will receive one of the several medications proposed to treat COVID-19, including patients of reproductive age. Given that some medications have shown adverse effects on sperm quality, there might be a transgenerational concern. We aim at examining the association between drugs proposed to treat COVID-19 when taken by the father around conception and any pre-term birth or major birth defects in offspring in a nation-wide cohort study using Danish registry data. Offspring whose father filled at least one prescription of the following medications in the 3 months preceding conception were considered exposed: chloroquine, hydroxychloroquine, losartan, azithromycin, naproxen, dexamethasone and prednisone. Results For azithromycin and naproxen, large numbers of offspring were exposed (> 1800 offspring), and we found no association with adverse birth outcomes. For chloroquine, losartan and dexamethasone, exposure was intermediate (~ 900 offspring), and there was no statistically significant association with birth defects. For hydroxychloroquine and prednisone, exposure was limited (< 300 offspring). Our evidence suggests that azithromycin and naproxen are safe with respect to pre-term birth and birth defects. For the other drugs investigated larger exposures are needed for conclusive statements.

Higher in vivo Cortical Intracellular Volume Fraction Associated with Lithium Therapy in Bipolar Disorder: A Multicenter NODDI Study

2019 ◽  
Vol 88 (3) ◽  
pp. 171-176 ◽  
Author(s):  
Samuel Sarrazin ◽  
Cyril Poupon ◽  
Achille Teillac ◽  
Jean-François Mangin ◽  
Mircea Polosan ◽  
...  
Keyword(s):  
Bipolar Disorder ◽  
Volume Fraction ◽  
Lithium Therapy ◽  
Intracellular Volume

scholarly journals Comparing Usual Dietary Intakes Among Subgroups of Mothers in the Year Before Pregnancy

2018 ◽  
Vol 134 (2) ◽  
pp. 155-163 ◽  
Author(s):  
Suzan L. Carmichael ◽  
Chen Ma ◽  
Marcia L. Feldkamp ◽  
Gary M. Shaw ◽  
Keyword(s):  
Dietary Intake ◽  
Birth Defects ◽  
Population Based ◽  
Reproductive Age ◽  
Dietary Intakes ◽  
Reference Groups ◽  
Annual Household Income ◽  
High Dietary Intake ◽  
Adverse Pregnancy ◽  
Maternal Overweight

Objective: The quantity and quality of dietary intake among women of reproductive age has important public health implications for nutritional status during pregnancy. We described dietary intake during the year before pregnancy among a large, diverse group of US mothers. Methods: We examined data from 11 109 mothers who gave birth from 1997 through 2011 and participated in a population-based case-control study, the National Birth Defects Prevention Study, as controls (mothers who had babies without major birth defects). We examined whether subgroups of mothers at elevated risk of adverse pregnancy outcomes were more likely than their reference groups to have high dietary intake (>90th percentile of intake) or low dietary intake (<10th percentile of intake). We examined dietary intake of 22 nutritional factors, which were estimated from responses to a food frequency questionnaire. Results: Participants who were aged <20, were nulliparous, had <high school diploma or <$20 000 annual household income, were non-Hispanic black, were underweight or obese, did not intend to become pregnant, did not take folic acid–containing vitamin supplements, or smoked had worse dietary intakes than their reference groups. For example, 17.5% of participants aged <20 had a low score on the diet quality index and 5.3% had a high score (vs expected values of 10%). Participants who were aged ≥35, were Hispanic, or had prepregnancy diabetes tended to have better dietary intakes than their reference groups. Maternal overweight and prepregnancy hypertension had few significant associations. Conclusions: Strategies are needed to ensure optimal nutrition among all childbearing women.

scholarly journals Periconceptional surveillance for prevention of anaemia and birth defects in Southern India: protocol for a biomarker survey in women of reproductive age

BMJ Open ◽  
2020 ◽  
Vol 10 (10) ◽  
pp. e038305
Author(s):  
Julia L Finkelstein ◽  
Amy Fothergill ◽  
Christina B Johnson ◽  
Heather M Guetterman ◽  
Beena Bose ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Birth Defects ◽  
Population Based ◽  
Medical Centre ◽  
Reproductive Age ◽  
Southern India ◽  
Vitamin B ◽  
Micronutrient Deficiencies ◽  
Women Of Reproductive Age ◽  
Registration Number

IntroductionWomen of reproductive age (WRA) are a high-risk population for anaemia and micronutrient deficiencies. Evidence supports the role of periconceptional nutrition in the development of adverse pregnancy complications. However, in India, there are limited population-based data to guide evidence-based recommendations and priority setting. The objective of this study is to conduct a population-based biomarker survey of anaemia and vitamin B12 and folate status in WRA as part of a periconceptional surveillance programme in Southern India.MethodsWRA (15–40 years) who are not pregnant or lactating and reside within 50 km2 of our community research site in Southern India will be screened and invited to participate in the biomarker survey at our research facility at Arogyavaram Medical Centre. After informed consent/assent, structured interviews will be conducted by trained nurse enumerators to collect sociodemographic, dietary, anthropometry, health and reproductive history data. Venous blood samples will be collected at enrolment; whole blood will be analysed for haemoglobin. Plasma, serum and red blood cells (RBCs) will be processed and stored <−80°C until batch analysis. Vitamin B12 concentrations will be measured via chemiluminescence, and RBC and serum folate concentrations will be evaluated using the World Health Organisation (WHO)-recommended microbiological assay at our laboratory in Bangalore. A WHO surveillance system will also be established to determine the baseline prevalence of birth defects in this setting.Ethics and disseminationThis study has obtained clearance from the Health Ministry Screening Committee of the Indian Council of Medical Research. The study protocol was reviewed and approved by the Institutional Review Board at Cornell University and the Institutional Ethics Committees at Arogyavaram Medical Centre and St. John’s Research Institute. Findings from this biomarker survey will establish the burden of anaemia and micronutrient deficiencies in WRA and directly inform a randomised trial for anaemia and birth defects prevention in Southern India. The results of this study will be disseminated at international research conferences and as published articles in peer-reviewed journals.Trial registration numbersClinical trials registration number NCT04048330, NCT03853304 and Clinical Trials Registry of India (CTRI) registration number REF/2019/03/024479.

Lithium Therapy for Bipolar Disorder

2018 ◽  
Vol 14 (2) ◽  
pp. 93-99 ◽  
Author(s):  
Brent Luu ◽  
George Rodway
Keyword(s):  
Bipolar Disorder ◽  
Lithium Therapy
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