Faculty Opinions recommendation of Review of prescribing information for influenza vaccines for pregnant and lactating women.

BackgroundThe U.S. Food and Drug Administration implemented the new Pregnancy and Lactation Labeling Rule (PLLR) in June 2015. Under PLLR, all new drug applications were to present a narrative risk assessment (as opposed to letter category), while drug approvals after June 2001, were required to phase in by June 2020. The purpose of this study was to assess the quality of presented pregnancy and lactation data in the drug labeling and degree of adherence to the PLLR.Design/MethodsWe reviewed the labeling data of all new molecular entities (NMEs) approved from 1999–2017. The pregnancy and lactation information was classified as: 1. Harmful to use 2. Safe to use 3. Consideration of safety and efficacy. For drugs approvals after June 2001, presence of pregnancy letter category system was noted.ResultsOf the 456 NMEs, 131 (29%) were classified as harmful to use in pregnancy and 207 (45%) as harmful to use during lactation. This number did not follow any specific pattern over the course of 19 years. Less than 1% of drugs were deemed to be safe during pregnancy or lactation. Human data was the source of pregnancy or lactation information for only 2% of drugs. Up to 70% of drugs belonged to each implementation schedule has yet to meet the PLLR compliance requirement.Conclusion(s)Pregnant and lactating women are mostly advised against use of medications that might be needed for their health and health of their infants based on very limited data. Pharmaceutical companies lagged behind the required adherence rule for labeling updates on pregnancy and lactation information.Disclosure(s)Nothing to disclose

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Warning Added to Xigris Prescribing Information

Internal Medicine News ◽

10.1016/s1097-8690(05)70415-7 ◽

2005 ◽

Vol 38 (8) ◽

pp. 59

Author(s):

MICHELE G. SULLIVAN

Keyword(s):

Prescribing Information

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Live influenza vaccines being tested

PsycEXTRA Dataset ◽

10.1037/e528632009-001 ◽

1978 ◽

Author(s):

Roger S. Johnson

Keyword(s):

Influenza Vaccines

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Oxytocin secretion in response to suckling in lactating women

Acta Endocrinologica ◽

10.1530/acta.0.107s134 ◽

1984 ◽

Vol 104 (4_Supplb) ◽

pp. S134-S135

Author(s):

F. JÄNICKE ◽

H.K. RJOSK ◽

K. VON WERDER

Keyword(s):

Lactating Women

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How various doses of iodine effect on thyroid gland in pregnant and lactating women, on the example of regional studies in russian federation?

Endocrine Abstracts ◽

10.1530/endoabs.70.aep901 ◽

2020 ◽

Author(s):

Anastasia Rybakova ◽

Nadezhda Platonova ◽

Ekaterina Troshina ◽

Fatima Abdulhabirova

Keyword(s):

Thyroid Gland ◽

Russian Federation ◽

Regional Studies ◽

Lactating Women

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Innovative approaches to the correction of chronotrope status of pregnant and lactating women

HEALTH OF WOMAN ◽

10.15574/hw.2016.114.37 ◽

2016 ◽

pp. 37-40

Author(s):

S.I. Zhuk ◽

◽

K.K. Bondarenko ◽

Keyword(s):

Folic Acid ◽

Neural Tube ◽

Active Form ◽

Biologically Active ◽

Lactating Women ◽

Pathological Conditions ◽

Prevention And Treatment ◽

The Impact ◽

High Bioavailability ◽

Key Words Mthfr

Most recent studies show the impact of violations in the metabolism of folate and metin period in the pathogenesis of neural tube defects (NTD) of the fetus. Metafolin has a number of advantages, which primarily includes direct intake of substances in biologically active form and the optimum effect, even in the case when the patient homozygote and/or heterozygote genotype 677С T polymorphism in MTHFR. With the aim of prevention and treatment of various pathological conditions related to folate deficiency during pregnancy, it is advisable to apply vitamin-mineral complexes, containing metafolin - active form of folate with high bioavailability. Key words: MTHFR, metafolin, folic acid, pregnancy.

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