Drug Safety Update

We 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).

• Therapeutic area: Paediatrics and neonatology and 2 others
• Published: 27 June 2023

We 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…

• Therapeutic area: Neurology and 2 others
• Published: 21 July 2022

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 …

• Therapeutic area: Dispensing GP practices and 2 others
• Published: 15 March 2022

Information on the newly launched Safer Medicines in Pregnancy and Breastfeeding Consortium and a new report on optimising data on medicines used during pregnancy.

• Therapeutic area: Obstetrics, gynaecology and fertility and 1 others
• Published: 18 February 2021

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…

• Therapeutic area: Neurology and 1 others
• Published: 7 January 2021

SSRIs 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 resul…

• Therapeutic area: Pregnancy and 1 others
• Published: 7 January 2021

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…

• Therapeutic area: Neurology and 1 others
• Published: 16 November 2020

Updated 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…

• Therapeutic area: Infectious disease and 1 others
• Published: 22 October 2020

In 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 …

• Therapeutic area: Neurology and 4 others
• Published: 12 February 2020

Recent 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.

• Therapeutic area: Anaesthesia and intensive care and 3 others
• Published: 27 January 2020

Fingolimod 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…

• Therapeutic area: Neurology and 2 others
• Published: 19 September 2019

New 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…

• Therapeutic area: Cancer and 6 others
• Published: 19 June 2019

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…

• Therapeutic area: Endocrinology, diabetology and metabolism and 4 others
• Published: 17 May 2019

Ongoing 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…

• Therapeutic area: Neurology and 5 others
• Published: 16 April 2019

Pharmacokinetic 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…

• Therapeutic area: Immunosuppression and transplantation and 3 others
• Published: 16 April 2019

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.

• Therapeutic area: Endocrinology, diabetology and metabolism and 3 others
• Published: 21 March 2019

Carbimazole 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…

• Therapeutic area: Endocrinology, diabetology and metabolism and 3 others
• Published: 18 February 2019

Sildenafil 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…

• Therapeutic area: Cardiovascular disease and lipidology and 5 others
• Published: 14 November 2018

New 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…

• Therapeutic area: Immunosuppression and transplantation and 4 others
• Published: 17 July 2018

Report 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…

• Therapeutic area: Anaesthesia and intensive care and 23 others
• Published: 17 July 2018

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.

• Therapeutic area: Infectious disease and 3 others
• Published: 22 June 2018