tag:www.gov.uk,2005:/drug-safety-updateDrug Safety Update about Obstetrics, gynaecology and fertility2025-05-15T11:30:20+01:00HM Governmenttag:www.gov.uk,2005:/drug-safety-update/thiopurines-and-intrahepatic-cholestasis-of-pregnancy2025-05-15T11:30:20+01:00Thiopurines and intrahepatic cholestasis of pregnancy Intrahepatic cholestasis of pregnancy (ICP) has been rarely reported in patients treated with azathioprine products and is believed to be a risk applicable to all drugs in the thiopurine class (azathioprine, mercaptopurine a鈥�tag:www.gov.uk,2005:/drug-safety-update/fezolinetantv-veoza-risk-of-liver-injury-new-recommendations-to-minimise-risk2025-04-10T12:00:08+01:00Fezolinetant鈻�(Veoza): risk of liver injury; new recommendations to minimise riskFezolinetant treatment is associated with a risk of drug induced liver injury. New recommendations have been introduced to minimise this risk. Liver function should be monitored before and during treatment in all patients ta鈥�tag:www.gov.uk,2005:/drug-safety-update/valproate-belvo-convulex-depakote-dyzantil-epilim-epilim-chrono-or-chronosphere-episenta-epival-and-syonellv-review-by-two-specialists-is-required-for-initiating-valproate-but-not-for-male-patients-already-taking-valproate2025-02-13T15:02:39+00:00Valproate (Belvo, Convulex, Depakote, Dyzantil, Epilim, Epilim Chrono or Chronosphere, Episenta, Epival, and Syonell鈻�): review by two specialists is required for initiating valproate but not for male patients already taking valproateReview by two specialists remains in place for patients initiating valproate under 55 years of age but the Commission on Human Medicines (CHM) has advised that it will not be required for men (or males) currently taking valp鈥�tag: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. 皇冠体育app review concluded that blood pressure monitoring of patients prescribed with this drug is es鈥�tag:www.gov.uk,2005:/drug-safety-update/letters-and-medicine-recalls-sent-to-healthcare-professionals-in-march-20242024-04-29T16:03:09+01:00Letters and medicine recalls sent to healthcare professionals in March 2024A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices.tag:www.gov.uk,2005:/drug-safety-update/letters-and-medicine-recalls-sent-to-healthcare-professionals-in-february-20242024-03-27T11:53:02+00:00Letters and medicine recalls sent to healthcare professionals in February 2024A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices.tag:www.gov.uk,2005:/drug-safety-update/letters-and-medicine-recalls-sent-to-healthcare-professionals-in-january-20242024-02-20T11:01:30+00:00Letters and medicine recalls sent to healthcare professionals in January 2024A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices. tag:www.gov.uk,2005:/drug-safety-update/valproate-belvo-convulex-depakote-dyzantil-epilim-epilim-chrono-or-chronosphere-episenta-epival-and-syonellv-new-safety-and-educational-materials-to-support-regulatory-measures-in-men-and-women-under-55-years-of-age2024-01-22T15:41:20+00:00Valproate (Belvo, Convulex, Depakote, Dyzantil, Epilim, Epilim Chrono or Chronosphere, Episenta, Epival, and Syonell鈻�): new safety and educational materials to support regulatory measures in men and women under 55 years of ageNew safety and educational materials have been introduced for men and women and healthcare professionals to reduce the harms from valproate, including the significant risk of serious harm to the baby if taken during pregnanc鈥�tag:www.gov.uk,2005:/drug-safety-update/letters-and-medicine-recalls-sent-to-healthcare-professionals-in-september-20232023-10-31T10:29:09+00:00Letters and medicine recalls sent to healthcare professionals in September 2023A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices, and information about the publication of two recent Device Safety Information pages. tag:www.gov.uk,2005:/drug-safety-update/valproate-re-analysis-of-study-on-risks-in-children-of-men-taking-valproate2023-08-30T10:31:12+01:00Valproate: re-analysis of study on risks in children of men taking valproate We are providing an update on a retrospective observational study on the risk to children born to men who took valproate in the 3 months before conception and on the need for the re-analysis of the data from this study befor鈥�tag:www.gov.uk,2005:/drug-safety-update/letters-and-medicine-recalls-sent-to-healthcare-professionals-in-june-20232023-07-24T13:59:23+01:00Letters and medicine recalls sent to healthcare professionals in June 2023 A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices and a reminder of a recent MHRA National Patient Safety Alert to highlight the potential risk of underdosing 鈥�tag:www.gov.uk,2005:/drug-safety-update/valproate-reminder-of-current-pregnancy-prevention-programme-requirements-information-on-new-safety-measures-to-be-introduced-in-the-coming-months2022-12-12T12:00:31+00:00Valproate: reminder of current Pregnancy Prevention Programme requirements; information on new safety measures to be introduced in the coming monthsIn view of data showing ongoing exposure to valproate in pregnancy, this article reminds healthcare professionals of the risks in pregnancy and the current Pregnancy Prevention Programme requirements, and provides informatio鈥�tag:www.gov.uk,2005:/drug-safety-update/letters-and-medicine-recalls-sent-to-healthcare-professionals-in-july-20222022-08-23T11:04:18+01:00Letters and medicine recalls sent to healthcare professionals in July 2022A summary of recent letters and notifications sent to healthcare professionals about medicines, and a patient safety alert on mexiletine hydrochloride.tag:www.gov.uk,2005:/drug-safety-update/letters-and-medicine-recalls-sent-to-healthcare-professionals-in-january-20222022-02-15T14:06:11+00:00Letters and medicine recalls sent to healthcare professionals in January 2022A summary of recent letters, medicine recalls and notifications sent to healthcare professionals.tag:www.gov.uk,2005:/drug-safety-update/letters-and-medicine-recalls-sent-to-healthcare-professionals-in-november-20212021-12-10T11:00:52+00:00Letters and medicine recalls sent to healthcare professionals in November 2021A summary of recent letters, medicine recalls and notifications sent to healthcare professionals.tag:www.gov.uk,2005:/drug-safety-update/letters-and-medicine-recalls-sent-to-healthcare-professionals-in-july-20212021-08-16T14:04:43+01:00Letters and medicine recalls sent to healthcare professionals in July 2021 A summary of recent letters, medicine recalls and notifications sent to healthcare professionalstag:www.gov.uk,2005:/drug-safety-update/letters-and-medicine-recalls-sent-to-healthcare-professionals-in-june-20212021-07-07T17:13:08+01:00Letters and medicine recalls sent to healthcare professionals in June 2021 A summary of letters and drug alerts recently sent to healthcare professionals.tag:www.gov.uk,2005:/drug-safety-update/letters-and-medicine-recalls-sent-to-healthcare-professionals-in-may-20212021-06-17T10:01:25+01:00Letters and medicine recalls sent to healthcare professionals in May 2021 A summary of letters and recent medicine recalls and notifications sent to healthcare professionals.tag:www.gov.uk,2005:/drug-safety-update/ulipristal-acetate-5mg-esmya-further-restrictions-due-to-risk-of-serious-liver-injury2021-02-18T11:36:51+00:00Ulipristal acetate 5mg (Esmya): further restrictions due to risk of serious liver injury 皇冠体育app indication of ulipristal acetate 5mg for uterine fibroids has been further restricted due to the risk of serious liver injury and liver failure, with some cases requiring liver transplantation. Although the temporary sus鈥�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/letters-and-drug-alerts-sent-to-healthcare-professionals-in-january-20212021-02-18T11:34:55+00:00Letters and drug alerts sent to healthcare professionals in January 2021A summary of letters and drug alerts recently sent to healthcare professionals.tag:www.gov.uk,2005:/drug-safety-update/valproate-pregnancy-prevention-programme-temporary-advice-for-management-during-coronavirus-covid-192020-05-21T14:45:59+01:00 Valproate Pregnancy Prevention Programme: temporary advice for management during coronavirus (COVID-19)Guidance has been published to support initiation of valproate in female patients and for annual review and pregnancy testing during the coronavirus pandemic. tag:www.gov.uk,2005:/drug-safety-update/letters-and-drug-alerts-sent-to-healthcare-professionals-in-april-20202020-05-21T14:45:31+01:00Letters and drug alerts sent to healthcare professionals in April 2020A summary of letters and drug alerts recently sent to healthcare professionals.tag:www.gov.uk,2005:/drug-safety-update/letters-and-drug-alerts-sent-to-healthcare-professionals-in-march-20202020-04-27T15:59:03+01:00Letters and drug alerts sent to healthcare professionals in March 2020A summary of letters and drug alerts recently sent to healthcare professionals.tag:www.gov.uk,2005:/drug-safety-update/esmya-ulipristal-acetate-suspension-of-the-licence-due-to-risk-of-serious-liver-injury2020-03-18T14:25:49+00:00Esmya (ulipristal acetate): suspension of the licence due to risk of serious liver injuryContact patients currently taking Esmya for uterine fibroids as soon as possible and advise them to stop their treatment. 皇冠体育app licence for Esmya has been suspended to protect public health while a safety review is conducted f鈥�tag:www.gov.uk,2005:/drug-safety-update/valproate-epilim-depakote-pregnancy-prevention-programme-updated-educational-materials2020-02-12T16:43:54+00:00Valproate (Epilim鈻�, Depakote鈻�) 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 鈥�tag:www.gov.uk,2005:/drug-safety-update/nexplanon-etonogestrel-contraceptive-implants-new-insertion-site-to-reduce-rare-risk-of-neurovascular-injury-and-implant-migration2020-02-12T16:43:42+00:00Nexplanon (etonogestrel) contraceptive implants: new insertion site to reduce rare risk of neurovascular injury and implant migration Amended advice on the insertion site for Nexplanon contraceptive implants following concerns regarding reports of neurovascular injury and implants migrating to the vasculature (including the pulmonary artery).
tag:www.gov.uk,2005:/drug-safety-update/letters-and-drug-alerts-sent-to-healthcare-professionals-in-january-20202020-02-12T16:43:17+00:00Letters and drug alerts sent to healthcare professionals in January 2020 Letters were sent about methotrexate, modafinil, Ecalta, Picato, Nexplanon, valproate medicines, e-cigarettes, and Lemtrada. Alerts were issued about finasteride, codeine/paracetamol, and Picato.
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/letters-and-drug-alerts-sent-to-healthcare-professionals-in-december-20192020-01-27T15:33:13+00:00Letters and drug alerts sent to healthcare professionals in December 2019Letters were sent about Insuman insulin products, mecasermin, and valproate medicines. Recalls were issued about ranitidine medicines and Paclitaxel.tag:www.gov.uk,2005:/drug-safety-update/letters-and-drug-alerts-sent-to-healthcare-professionals-in-november-20192019-12-16T12:04:34+00:00Letters and drug alerts sent to healthcare professionals in November 2019Letters were sent about ranibizumab and Emerade adrenaline auto-injectors. Alerts were issued about ranitidine, paracetamol, omeprazole, mitomycin-C Kyowa, folic acid, and Emerade adrenaline auto-injectors. tag:www.gov.uk,2005:/drug-safety-update/letters-and-drug-alerts-sent-to-healthcare-professionals-in-october-20192019-11-21T14:56:49+00:00Letters and drug alerts sent to healthcare professionals in October 2019Letters were sent about quadrivalent influenza vaccine, fentanyl ampoules, and Volibris (ambrisentan), and a number of pharmacy-level recalls were issued for ranitidine-containing products. Other alerts issued in October 201鈥�tag:www.gov.uk,2005:/drug-safety-update/medical-device-alerts-issued-in-october-20192019-11-21T14:56:35+00:00Medical Device Alerts issued in October 2019Alerts were issued about Rocket and NuSurgix fetal blood sampling (FBS) amnioscopes and kits, Philips Efficia professional-use defibrillators/monitors, and CME T-34 3rd edition syringe driver pumps. A notice was also issued 鈥�tag:www.gov.uk,2005:/drug-safety-update/letters-and-drug-alerts-sent-to-healthcare-professionals-in-september-20192019-10-18T15:39:23+01:00Letters and drug alerts sent to healthcare professionals in September 2019Letters were issued about parenteral nutrition products, ranibizumab, ingenol mebutate gel, adrenaline auto-injectors, and fingolimod. Recall alerts were recently issued about ranitidine, aripiprazole, and bisacodyl.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鈻�): 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鈥�tag:www.gov.uk,2005:/drug-safety-update/hormone-replacement-therapy-hrt-further-information-on-the-known-increased-risk-of-breast-cancer-with-hrt-and-its-persistence-after-stopping2019-08-30T08:55:30+01:00Hormone replacement therapy (HRT): further information on the known increased risk of breast cancer with HRT and its persistence after stopping New data have confirmed that the risk of breast cancer is increased during use of all types of HRT, except vaginal estrogens, and have also shown that an excess risk of breast cancer persists for longer after stopping HRT th鈥�tag:www.gov.uk,2005:/drug-safety-update/letters-and-drug-alerts-sent-to-healthcare-professionals-in-july-20192019-08-19T15:47:40+01:00Letters and drug alerts sent to healthcare professionals in July 2019Letters were sent about Oncaspar鈻� (pegaspargase), Ketalar (ketamine) injection, and Elmiron (pentosan polysulfate sodium). A recall was issued for several medicines taken out of the regulated medicines supply chain, includin鈥�tag:www.gov.uk,2005:/drug-safety-update/letters-and-drug-alerts-sent-to-healthcare-professionals-in-june-20192019-07-17T13:34:54+01:00Letters and drug alerts sent to healthcare professionals in June 2019Letters were sent about Myocrisin (sodium aurothiomalate), Cerliponase alfa (Brineura鈻�), Darzalex鈻�(daratumumab), retinoids鈻�, and febuxostat (Adenuric). A recall alert was issued for medicines that were taken out of the regul鈥�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鈻�: 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鈥�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鈥�7 days in pregnancy has been associated with skeletal adverse effects and hypocalcaemia and hypermagnesemia in neonates. If use of magnesium sulfate in pregnancy鈥�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鈥�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鈻�, Stribild) is lower during the second and third trimesters of pregnancy than postpartum. Low elvitegravir exposure may be associated wi鈥�tag:www.gov.uk,2005:/drug-safety-update/letters-and-drug-alerts-sent-to-healthcare-professionals-in-march-20192019-04-16T15:53:23+01:00Letters and drug alerts sent to healthcare professionals in March 2019Letters were sent about Xeljanz鈻� (tofacitinib), ranitidine, Nulojix (belatacept), fluoroquinolone antibiotics, Genvoya鈻�, Stribild鈻�, Tybost, and belimumab (Benlysta鈻�). Drug alerts were issued about Accord losartan potassium c鈥�tag:www.gov.uk,2005:/drug-safety-update/fluoroquinolone-antibiotics-new-restrictions-and-precautions-for-use-due-to-very-rare-reports-of-disabling-and-potentially-long-lasting-or-irreversible-side-effects2019-03-21T11:50:07+00:00Fluoroquinolone antibiotics: new restrictions and precautions for use due to very rare reports of disabling and potentially long-lasting or irreversible side effects Disabling, long-lasting or potentially irreversible adverse reactions affecting musculoskeletal and nervous systems have been reported very rarely with fluoroquinolone antibiotics. Fluoroquinolone treatment should be discont鈥�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鈥�tag:www.gov.uk,2005:/drug-safety-update/sglt2-inhibitors-reports-of-fournier-s-gangrene-necrotising-fasciitis-of-the-genitalia-or-perineum2019-02-20T08:51:21+00:00SGLT2 inhibitors: reports of Fournier鈥檚 gangrene (necrotising fasciitis of the genitalia or perineum) If Fournier鈥檚 gangrene is suspected, stop the SGLT2 inhibitor and start treatment urgently (including antibiotics and surgical debridement). Fournier鈥檚 gangrene is a rare but potentially life-threatening infection that requi鈥�tag:www.gov.uk,2005:/drug-safety-update/letters-and-drug-alerts-sent-to-healthcare-professionals-in-january-20192019-02-20T08:51:12+00:00Letters and drug alerts sent to healthcare professionals in January 2019Letters were sent to healthcare professionals about Lartruvo鈻� (olaratumab), quadrivalent influenza vaccine (split virion, inactivated), SGLT2 inhibitors, and carbimazole and thiamazole (synonym: methimazole)-containing produ鈥�tag:www.gov.uk,2005:/drug-safety-update/valproate-medicines-are-you-in-acting-in-compliance-with-the-pregnancy-prevention-measures2018-12-18T12:44:49+00:00Valproate medicines: are you acting in compliance with the pregnancy prevention measures?Although use of valproate medicines in female patients continues to slowly decline, there is wide variation in prescribing between Clinical Commissioning Groups (CCGs). Women continue to report instances when they have not r鈥�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. 皇冠体育app STRIDER clinical trial, which was studying the use of sildenafil in pregnancy for intrauterine growth restriction, h鈥�