Pregnancy, Fetal, and Infant Outcomes Following Maternal Exposure to Glatiramer Acetate During Pregnancy and Breastfeeding

Kaplan, Sigal; Zeigarnik, M.V.; Stern, Tal

doi:10.1007/s40264-022-01168-1

Cited by 11 publications

(6 citation statements)

References 28 publications

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“…The impact of fluctuations in milk composition and fat content or the potential for increased exposure associated with clinical or subclinical mastitis were not discussed [ 59 , 60 ]. No studies defined the extent of breastfeeding, whether exclusive or partial: recent studies relied on self-report [ 33 , 48 , 61 ]. All studies relied on maternal self-report of breastfeeding: this may over-estimate duration [ 62 ] and initiation of breastfeeding [ 63 ], but is considered reasonably accurate if recalled within 3 years [ 64 ].…”

Section: Resultsmentioning

confidence: 99%

“…The PRAMS database contains whole-population data on infant outcomes, but marijuana (cannabis) use was taken from self-reported questionnaires from a stratified sample of live births across the USA and links with birth certificate information [29]. Spontaneous reports formed the basis of five studies and four databases [30][31][32][33][34]: two of these studies were from the olanzapine manufacturer's databases, and one from glatiramer acetate manufacturer's database [33]. We identified only one national database reporting adverse drug reactions (ADRs) in breastfed infants: the French spontaneous reporting database [30], and only one report of an adverse event affecting breastfeeding in the Uppsala Monitoring Centre international database [32].…”

Section: Databases Identifiedmentioning

confidence: 99%

“…[29,39] compared outcomes for those using or not using marijuana. Nine papers reported on both pregnancy and breastfeeding exposures [29,[31][32][33][35][36][37][38]. Psychotropic medicines, but not marijuana, appeared to be associated with a relatively high incidence of suboptimal perinatal outcomes, including withdrawal reactions and poor suckling [36].…”

Section: Plos Onementioning

confidence: 99%

“…It was the only cohort study with >200 participants. The six databases from information services [32,33,[35][36][37][38] were vulnerable to bias emanating from self-selection and non-response to follow up. The PRAMS database was vulnerable to non-response bias, despite exhaustive attempts at telephone contact, and the MoBa recruited cohort to volunteer bias.…”

Section: Risk Of Biasmentioning

confidence: 99%

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Where are the data linking infant outcomes, breastfeeding and medicine exposure? A systematic scoping review

2023

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Introduction Information on the impact of medicines on breastfeeding and the breastfed infant remains scarce. The aims of this review were to identify databases and cohorts holding this information, and pinpoint current information and research deficits. Method We searched 12 electronic databases, including PubMed/ Medline and Scopus, using a combination of controlled vocabulary (MeSH terms) and free text terms. We included studies reporting data from databases with information on breastfeeding, medicines exposure, and infant outcomes. We excluded studies not reporting all three parameters. Two reviewers independently selected papers and extracted data using a standardised spreadsheet. Risk of bias was assessed. Recruited cohorts with relevant information were tabulated separately. Discrepancies were resolved by discussion. Results From 752 unique records, 69 studies were identified for full review. Eleven papers reported analyses from ten established databases with information on maternal prescription or non-prescription drugs, breastfeeding and infant outcomes. Twenty-four cohort studies were also identified. No studies reported educational or long-term developmental outcomes. The data are too sparse to warrant any firm conclusions, beyond the need for more data. The overall picture hints at 1) unquantifiable, but probably rare, serious harms to infants exposed to medicines via breastmilk, 2) unknown long-term harms, and 3) a more insidious but more pervasive harm in terms of reduced breastfeeding rates following medicines exposure in late pregnancy and peri-partum. Implications Analyses of databases reporting on the full population are needed to quantify any adverse effects of medicines and identify dyads at risk of harm from prescribed medicines while breastfeeding. This information is essential to ensure 1) infants are monitored appropriately for any adverse drug reactions 2) inform breastfeeding patients using long-term medicines as to whether the benefits of breastfeeding outweigh exposure to medicines via breastmilk and 3) target additional support to breastfeeding patients whose medicines may affect breastfeeding. The protocol is registered with the Registry of Systematic Reviews, no.994.

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Section: Resultsmentioning

confidence: 99%

Section: Databases Identifiedmentioning

confidence: 99%

Section: Plos Onementioning

confidence: 99%

Section: Risk Of Biasmentioning

confidence: 99%

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Where are the data linking infant outcomes, breastfeeding and medicine exposure? A systematic scoping review

2023

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“…Exposure to glatiramer acetate in the first trimester did not increase risk of spontaneous abortions, preterm birth, low birth weight, or major congenital malformations compared with pregnancies in women with multiple sclerosis unexposed to disease-modifying therapies in a prospective cohort of 246 pregnancies (151 exposed to glatiramer acetate). 97 In a pharmacovigilance database comprising 702 pregnancies exposed to glatiramer acetate, rates of preterm birth, infant growth parameters, and major congenital malformations were similar to the background rate. 98 Although multiple registries showed first trimester exposure to β-interferons was not associated with increase in preterm births, spontaneous abortions, or major congenital malformations, supratherapeutic doses can slightly increase the risk of spontaneous abortions.…”

Section: Multiple Sclerosismentioning

confidence: 91%

Preventive Approaches in Women's Neurology: Prepartum, Pregnancy, and Postpartum

2022

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Women's neurology is the subspecialty within neurology concerned with the distinct healthcare needs of women. In this article, we review current literature and expert management strategies regarding disease-specific neurologic concerns of women, with an emphasis on issues related to contraception, pregnancy, and lactation. Health conditions that we discuss in this article include epilepsy, headache, stroke, multiple sclerosis, and Chiari I malformation. Current findings on neurologic disease in women suggest that many women with neurologic disease can safely manage their disease during pregnancy and have healthy children, though pregnancy planning is important in many conditions to mitigate risks and effective contraceptive management is important when pregnancy prevention is desired.

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Glatiramer acetate not associated with adverse pregnancy, foetal, or infant outcomes

2022

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Pregnancy, Fetal, and Infant Outcomes Following Maternal Exposure to Glatiramer Acetate During Pregnancy and Breastfeeding

Cited by 11 publications

References 28 publications

Where are the data linking infant outcomes, breastfeeding and medicine exposure? A systematic scoping review

Where are the data linking infant outcomes, breastfeeding and medicine exposure? A systematic scoping review

Preventive Approaches in Women's Neurology: Prepartum, Pregnancy, and Postpartum

Glatiramer acetate not associated with adverse pregnancy, foetal, or infant outcomes

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