tag:www.gov.uk,2005:/drug-safety-updateDrug Safety Update about Pregnancy2024-10-24T11:00:18+01:00HM Governmenttag:www.gov.uk,2005:/drug-safety-update/bromocriptine-monitor-blood-pressure-when-prescribing-bromocriptine-for-prevention-or-inhibition-of-post-partum-physiological-lactation2024-10-24T11:00:18+01:00Bromocriptine: monitor blood pressure when prescribing bromocriptine for prevention or inhibition of post-partum physiological lactation A safety review has been conducted by the MHRA following a Yellow Card report concerning a patient who was taking bromocriptine. The review concluded that blood pressure monitoring of patients prescribed with this drug is es�tag:www.gov.uk,2005:/drug-safety-update/topiramate-topamax-introduction-of-new-safety-measures-including-a-pregnancy-prevention-programme2024-06-20T11:11:14+01:00Topiramate (Topamax): introduction of new safety measures, including a Pregnancy Prevention ProgrammeTopiramate is now contraindicated in pregnancy and in women of childbearing potential unless the conditions of a Pregnancy Prevention Programme are fulfilled. This follows a review by the MHRA which concluded that the use of�tag:www.gov.uk,2005:/drug-safety-update/non-steroidal-anti-inflammatory-drugs-nsaids-potential-risks-following-prolonged-use-after-20-weeks-of-pregnancy2023-06-27T13:35:08+01:00Non-steroidal anti-inflammatory drugs (NSAIDs): potential risks following prolonged use after 20 weeks of pregnancyWe want to remind healthcare professionals that use of systemic (oral and injectable) NSAIDs such as ibuprofen, naproxen, and diclofenac is contraindicated in the last trimester of pregnancy (after 28 weeks of pregnancy).
tag:www.gov.uk,2005:/drug-safety-update/topiramate-topamax-start-of-safety-review-triggered-by-a-study-reporting-an-increased-risk-of-neurodevelopmental-disabilities-in-children-with-prenatal-exposure2022-07-21T11:03:55+01:00Topiramate (Topamax): start of safety review triggered by a study reporting an increased risk of neurodevelopmental disabilities in children with prenatal exposureWe have initiated a new safety review into topiramate as a result of an observational study reporting an increased risk of neurodevelopmental disabilities in children whose mothers took topiramate during pregnancy.
Topir�tag:www.gov.uk,2005:/drug-safety-update/metformin-in-pregnancy-study-shows-no-safety-concerns2022-03-15T14:30:51+00:00Metformin in pregnancy: study shows no safety concerns A large study has shown no safety issues of concern relating to the use of metformin during pregnancy. The licence for metformin now reflects that it can be considered for use during pregnancy and the periconceptional phase �tag:www.gov.uk,2005:/drug-safety-update/medicines-in-pregnancy-and-breastfeeding-new-initiative-for-consistent-guidance-report-on-optimising-data-for-medicines-used-during-pregnancy2021-02-18T11:36:03+00:00Medicines in pregnancy and breastfeeding: new initiative for consistent guidance; report on optimising data for medicines used during pregnancyInformation on the newly launched Safer Medicines in Pregnancy and Breastfeeding Consortium and a new report on optimising data on medicines used during pregnancy.tag:www.gov.uk,2005:/drug-safety-update/antiepileptic-drugs-in-pregnancy-updated-advice-following-comprehensive-safety-review2021-01-07T11:02:01+00:00Antiepileptic drugs in pregnancy: updated advice following comprehensive safety review A review of the risks of major congenital malformations and of adverse neurodevelopmental outcomes for antiepileptic drugs by the Commission on Human Medicines has confirmed that lamotrigine (Lamictal) and levetiracetam (Kep�tag:www.gov.uk,2005:/drug-safety-update/ssri-slash-snri-antidepressant-medicines-small-increased-risk-of-postpartum-haemorrhage-when-used-in-the-month-before-delivery2021-01-07T11:00:29+00:00SSRI/SNRI antidepressant medicines: small increased risk of postpartum haemorrhage when used in the month before deliverySSRIs and SNRIs are known to increase bleeding risks due to their effect on platelet function. Data from observational studies suggest that the use of SSRI/SNRI antidepressants during the month before delivery may result in �tag:www.gov.uk,2005:/drug-safety-update/modafinil-provigil-increased-risk-of-congenital-malformations-if-used-during-pregnancy2020-11-16T16:00:51+00:00Modafinil (Provigil): increased risk of congenital malformations if used during pregnancy Modafinil potentially increases the risk of congenital malformations when used in pregnancy. Modafinil should not be used during pregnancy and women of childbearing potential must use effective contraception during treatment�tag:www.gov.uk,2005:/drug-safety-update/dolutegravir-tivicay-triumeq-juluca-updated-advice-on-increased-risk-of-neural-tube-defects2020-10-22T14:15:24+01:00Dolutegravir (Tivicay�, Triumeq�, Juluca�): updated advice on increased risk of neural tube defectsUpdated safety recommendations have been issued as part of the European review evaluating cases of neural tube defects in babies born to mothers who became pregnant while taking the HIV medicine dolutegravir. Evidence collec�tag:www.gov.uk,2005:/drug-safety-update/valproate-epilim-depakote-pregnancy-prevention-programme-updated-educational-materials2020-02-12T16:43:54+00:00Valproate (Epilim�, Depakote�) pregnancy prevention programme: updated educational materialsIn January 2020, healthcare professionals received updated educational materials to support the valproate pregnancy prevention programme. Valproate is contraindicated in girls and women of childbearing potential, unless the �tag:www.gov.uk,2005:/drug-safety-update/ondansetron-small-increased-risk-of-oral-clefts-following-use-in-the-first-12-weeks-of-pregnancy2020-01-27T15:33:54+00:00Ondansetron: small increased risk of oral clefts following use in the first 12 weeks of pregnancyRecent epidemiological studies suggest exposure to ondansetron during the first trimester of pregnancy is associated with a small increased risk of the baby having a cleft lip and/or cleft palate.
tag:www.gov.uk,2005:/drug-safety-update/fingolimod-gilenya-increased-risk-of-congenital-malformations-new-contraindication-during-pregnancy-and-in-women-of-childbearing-potential-not-using-effective-contraception2019-09-19T11:41:11+01:00Fingolimod (Gilenya�): increased risk of congenital malformations; new contraindication during pregnancy and in women of childbearing potential not using effective contraceptionFingolimod is associated with an increased risk of major congenital malformations including cardiac, renal, and musculoskeletal defects, when used in pregnancy. Women of childbearing potential must use effective contraceptio�tag:www.gov.uk,2005:/drug-safety-update/oral-retinoid-medicines-revised-and-simplified-pregnancy-prevention-educational-materials-for-healthcare-professionals-and-women2019-06-19T14:12:40+01:00Oral retinoid medicines�: revised and simplified pregnancy prevention educational materials for healthcare professionals and womenNew prescriber checklists, patient reminder cards, and pharmacy checklists are available to support the Pregnancy Prevention Programme in women taking acitretin, alitretinoin, and isotretinoin. Advice about the risk of neuro�tag:www.gov.uk,2005:/drug-safety-update/magnesium-sulfate-risk-of-skeletal-adverse-effects-in-the-neonate-following-prolonged-or-repeated-use-in-pregnancy2019-05-17T14:55:08+01:00Magnesium sulfate: risk of skeletal adverse effects in the neonate following prolonged or repeated use in pregnancy Maternal administration of magnesium sulfate for longer than 5�7 days in pregnancy has been associated with skeletal adverse effects and hypocalcaemia and hypermagnesemia in neonates. If use of magnesium sulfate in pregnancy�tag:www.gov.uk,2005:/drug-safety-update/valproate-medicines-and-serious-harms-in-pregnancy-new-annual-risk-acknowledgement-form-and-clinical-guidance-from-professional-bodies-to-support-compliance-with-the-pregnancy-prevention-programme2019-04-16T15:54:11+01:00Valproate medicines and serious harms in pregnancy: new Annual Risk Acknowledgement Form and clinical guidance from professional bodies to support compliance with the Pregnancy Prevention ProgrammeOngoing patient survey data suggest that more effort is needed by clinicians to achieve full and timely compliance with the valproate Pregnancy Prevention Programme and meet the goal to rapidly reduce and eventually eliminat�tag:www.gov.uk,2005:/drug-safety-update/elvitegravir-boosted-with-cobicistat-avoid-use-in-pregnancy-due-to-risk-of-treatment-failure-and-maternal-to-child-transmission-of-hiv-12019-04-16T15:53:32+01:00Elvitegravir boosted with cobicistat: avoid use in pregnancy due to risk of treatment failure and maternal-to-child transmission of HIV-1Pharmacokinetic data indicate exposure of elvitegravir boosted with cobicistat (Genvoya�, Stribild) is lower during the second and third trimesters of pregnancy than postpartum. Low elvitegravir exposure may be associated wi�tag:www.gov.uk,2005:/drug-safety-update/medicines-with-teratogenic-potential-what-is-effective-contraception-and-how-often-is-pregnancy-testing-needed2019-03-21T11:49:37+00:00Medicines with teratogenic potential: what is effective contraception and how often is pregnancy testing needed? New guidance on contraceptive methods and frequency of pregnancy testing to reduce inadvertent exposures during pregnancy in a woman taking a medicine of teratogenic potential. tag:www.gov.uk,2005:/drug-safety-update/carbimazole-increased-risk-of-congenital-malformations-strengthened-advice-on-contraception2019-02-20T08:51:37+00:00Carbimazole: increased risk of congenital malformations; strengthened advice on contraceptionCarbimazole is associated with an increased risk of congenital malformations, especially when administered in the first trimester of pregnancy and at high doses. Women of childbearing potential should use effective contracep�tag:www.gov.uk,2005:/drug-safety-update/sildenafil-revatio-and-viagra-reports-of-persistent-pulmonary-hypertension-of-the-newborn-pphn-following-in-utero-exposure-in-a-clinical-trial-on-intrauterine-growth-restriction2018-11-14T11:50:11+00:00Sildenafil (Revatio and Viagra): reports of persistent pulmonary hypertension of the newborn (PPHN) following in-utero exposure in a clinical trial on intrauterine growth restrictionSildenafil is not authorised for use in pregnancy for the treatment of intrauterine growth restriction. The STRIDER clinical trial, which was studying the use of sildenafil in pregnancy for intrauterine growth restriction, h�tag:www.gov.uk,2005:/drug-safety-update/darunavir-boosted-with-cobicistat-avoid-use-in-pregnancy-due-to-risk-of-treatment-failure-and-maternal-to-child-transmission-of-hiv-12018-07-17T14:38:49+01:00Darunavir boosted with cobicistat: avoid use in pregnancy due to risk of treatment failure and maternal-to-child transmission of HIV-1New pharmacokinetic data show mean exposure of darunavir (brand name Prezista) boosted with cobicistat (available in combination in Rezolsta�, Symtuza�) to be lower during the second and third trimesters of pregnancy than du�tag:www.gov.uk,2005:/drug-safety-update/medicines-taken-during-pregnancy-please-report-suspected-adverse-drug-reactions-including-in-the-baby-or-child-on-a-yellow-card2018-07-17T14:35:39+01:00Medicines taken during pregnancy: please report suspected adverse drug reactions, including in the baby or child, on a Yellow CardReport to the Yellow Card Scheme suspected adverse reactions associated with medicines taken during pregnancy experienced by women or the baby or child. Obstetricians and midwives have a particularly important role in provid�tag:www.gov.uk,2005:/drug-safety-update/dolutegravir-tivicay-triumeq-juluca-signal-of-increased-risk-of-neural-tube-defects-do-not-prescribe-to-women-seeking-to-become-pregnant-exclude-pregnancy-before-initiation-and-advise-use-of-effective-contraception2018-06-22T12:48:35+01:00Dolutegravir (Tivicay�, Triumeq�, Juluca�): signal of increased risk of neural tube defects; do not prescribe to women seeking to become pregnant; exclude pregnancy before initiation and advise use of effective contraception New safety recommendations have been issued while an EU review evaluates cases of neural tube defects in babies born to mothers who became pregnant while taking the HIV medicine dolutegravir.