tag:www.gov.uk,2005:/drug-safety-updateDrug Safety Update about Paediatrics and neonatology2024-09-26T15:00:38+01:00HM Governmenttag:www.gov.uk,2005:/drug-safety-update/letters-and-medicine-recalls-sent-to-healthcare-professionals-in-august-20242024-09-26T15:00:38+01:00Letters and medicine recalls sent to healthcare professionals in August 2024 A 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-july-20242024-08-21T11:00:39+01:00Letters and medicine recalls sent to healthcare professionals in July 2024 A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices.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/montelukast-reminder-of-the-risk-of-neuropsychiatric-reactions2024-04-29T16:03:13+01:00Montelukast: reminder of the risk of neuropsychiatric reactionsHealthcare professionals prescribing montelukast should be alert to the risk of neuropsychiatric reactions in all patients including children and adolescents. Reported neuropsychiatric reactions include sleep disorders, hall�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/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/letters-and-medicine-recalls-sent-to-healthcare-professionals-in-august-20232023-09-26T14:30:07+01:00Letters and medicine recalls sent to healthcare professionals in August 2023A summary of recent letters and notifications sent to healthcare professionals about medicines, and a recent National Patient Safety Alert highlighting the risk of deaths and serious injuries from entrapment or falls relatin�tag:www.gov.uk,2005:/drug-safety-update/hyoscine-hydrobromide-patches-scopoderm-1-dot-5mg-patch-or-scopoderm-tts-patch-risk-of-anticholinergic-side-effects-including-hyperthermia2023-07-24T13:59:33+01:00Hyoscine hydrobromide patches (Scopoderm 1.5mg Patch or Scopoderm TTS Patch): risk of anticholinergic side effects, including hyperthermia There have been a small number of reports of serious and life-threatening anticholinergic side effects associated with hyoscine hydrobromide patches, particularly when used outside the licence. Healthcare professionals, pati�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/direct-acting-oral-anticoagulants-doacs-paediatric-formulations-reminder-of-dose-adjustments-in-patients-with-renal-impairment2023-05-25T10:53:33+01:00Direct-acting oral anticoagulants (DOACs): paediatric formulations; reminder of dose adjustments in patients with renal impairment Risk minimisation materials are available to support the safe use of new paediatric formulations of rivaroxaban (Xarelto) and dabigatran etexilate (Pradaxa). In addition, we ask healthcare professionals to consult the curren�tag:www.gov.uk,2005:/drug-safety-update/letters-and-medicine-recalls-sent-to-healthcare-professionals-in-january-20232023-02-27T15:01:51+00:00Letters and medicine recalls sent to healthcare professionals in January 2023 A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices. tag:www.gov.uk,2005:/drug-safety-update/topical-testosterone-testogel-risk-of-harm-to-children-following-accidental-exposure2023-01-25T13:25:11+00:00Topical testosterone (Testogel): risk of harm to children following accidental exposurePremature puberty and genital enlargement have been reported in children who were in close physical contact with an adult using topical testosterone and who were repeatedly accidentally exposed to this medicine. To reduce th�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�tag:www.gov.uk,2005:/drug-safety-update/dupilumab-dupixentv-risk-of-ocular-adverse-reactions-and-need-for-prompt-management2022-11-29T14:00:26+00:00Dupilumab (Dupixent�): risk of ocular adverse reactions and need for prompt management Healthcare professionals prescribing dupilumab should be alert to the risks of ocular reactions. New onset or worsening ocular symptoms require prompt review. Referral for ophthalmological examination should be made as appro�tag:www.gov.uk,2005:/drug-safety-update/letters-and-medicine-recalls-sent-to-healthcare-professionals-in-october-20222022-11-29T14:00:08+00:00Letters and medicine recalls sent to healthcare professionals in October 2022A summary of recent letters and notifications sent to healthcare professionals about medicines.tag:www.gov.uk,2005:/drug-safety-update/methylphenidate-long-acting-modified-release-preparations-caution-if-switching-between-products-due-to-differences-in-formulations2022-09-26T16:19:41+01:00Methylphenidate long-acting (modified-release) preparations: caution if switching between products due to differences in formulationsPrescribers and dispensers should use caution if switching patients between different long-acting formulations of methylphenidate (Concerta XL, Medikinet XL, Equasym XL, Ritalin LA, and generics) as different instructions fo�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/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/adrenaline-auto-injectors-reminder-for-prescribers-to-support-safe-and-effective-use2021-11-16T14:22:45+00:00Adrenaline auto-injectors: reminder for prescribers to support safe and effective useEmerade 300 and 500 microgram adrenaline auto-injectors have been re-supplied to the market following the implementation of corrective actions � patients and their caregivers should be provided with training and advice speci�tag:www.gov.uk,2005:/drug-safety-update/letters-and-medicine-recalls-sent-to-healthcare-professionals-in-october-20212021-11-16T14:22:16+00:00Letters and medicine recalls sent to healthcare professionals in October 2021A summary of recent letters, medicine recalls and notifications sent to healthcare professionals.tag:www.gov.uk,2005:/drug-safety-update/chloral-hydrate-cloral-betaine-welldorm-restriction-of-paediatric-indication2021-10-06T12:25:45+01:00Chloral hydrate, cloral betaine (Welldorm): restriction of paediatric indication The paediatric indication for chloral hydrate (for children aged 2 years and older) and cloral (previously chloral) betaine (children aged 12 years and older) has been restricted to short-term treatment (maximum 2 weeks) of �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/letters-and-medicine-recalls-sent-to-healthcare-professionals-in-march-20212021-04-27T14:22:10+01:00Letters and medicine recalls sent to healthcare professionals in March 2021A summary of letters and recent medicine recalls and notifications sent to healthcare professionals.tag:www.gov.uk,2005:/drug-safety-update/alkindi-hydrocortisone-granules-risk-of-acute-adrenal-insufficiency-in-children-when-switching-from-hydrocortisone-tablet-formulations-to-granules2021-02-18T11:36:23+00:00Alkindi (hydrocortisone granules): risk of acute adrenal insufficiency in children when switching from hydrocortisone tablet formulations to granules When children receiving replacement therapy for adrenal insufficiency are being switched from hydrocortisone tablets to Alkindi granules, parents or carers should be informed of the need to be extra vigilant for symptoms of �tag:www.gov.uk,2005:/drug-safety-update/erythromycin-update-on-known-risk-of-infantile-hypertrophic-pyloric-stenosis2020-12-17T17:08:48+00:00Erythromycin: update on known risk of infantile hypertrophic pyloric stenosis Updates have been made to the magnitude of the known risk of infantile hypertrophic pyloric stenosis following exposure to erythromycin in infancy as a result of new epidemiological data. The risk is particularly increased i�tag:www.gov.uk,2005:/drug-safety-update/letters-and-drug-alerts-sent-to-healthcare-professionals-in-november-20202020-12-17T17:08:25+00:00Letters and drug alerts sent to healthcare professionals in November 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-october-20202020-11-16T15:42:11+00:00Letters and drug alerts sent to healthcare professionals in October 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-september-20202020-10-22T14:14:36+01:00Letters and drug alerts sent to healthcare professionals in September 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-august-20202020-09-23T14:27:16+01:00Letters and drug alerts sent to healthcare professionals in August 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-july-20202020-08-26T14:07:26+01:00Letters and drug alerts sent to healthcare professionals in July 2020A summary of letters and drug alerts recently sent to healthcare professionals, including recommendations to reduce handling errors with leuprorelin-containing depot medicines.tag:www.gov.uk,2005:/drug-safety-update/stimulant-laxatives-bisacodyl-senna-and-sennosides-sodium-picosulfate-available-over-the-counter-new-measures-to-support-safe-use2020-08-18T09:27:28+01:00Stimulant laxatives (bisacodyl, senna and sennosides, sodium picosulfate) available over-the-counter: new measures to support safe use We have introduced pack size restrictions, revised recommended ages for use, and new safety warnings for over-the-counter stimulant laxatives (orally and rectally administered) following a national safety review. Advise pati�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/medical-device-alerts-issued-in-february-20202020-03-18T14:23:29+00:00Medical Device Alerts issued in February 2020Alerts were issued about CME T34 and T34L (T60) ambulatory syringe pumps, Cardinal Health tympanic thermometers, t:slim X2 insulin pump, and Mavidon skin preparation electrode gels.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/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/e-cigarette-use-or-vaping-reporting-suspected-adverse-reactions-including-lung-injury2020-01-27T15:34:14+00:00E-cigarette use or vaping: reporting suspected adverse reactions, including lung injuryBe vigilant for any suspected adverse reactions associated with use of e-cigarettes or vaping (including lung injury) and report them to the MHRA via the Yellow Card scheme. In this article we provide UK case definitions of �tag:www.gov.uk,2005:/drug-safety-update/mecasermin-increlex-risk-of-benign-and-malignant-neoplasia2020-01-27T15:33:33+00:00Mecasermin (Increlex�): risk of benign and malignant neoplasia Cases of benign and malignant neoplasms have been observed among children and adolescents who received treatment with mecasermin. Do not use mecasermin in children or adolescents with active or suspected neoplasia or with an�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/domperidone-for-nausea-and-vomiting-lack-of-efficacy-in-children-reminder-of-contraindications-in-adults-and-adolescents2019-12-16T12:04:09+00:00Domperidone for nausea and vomiting: lack of efficacy in children; reminder of contraindications in adults and adolescentsDomperidone is no longer licensed for use in children younger than 12 years or those weighing less than 35 kg. Results from a placebo-controlled study in children younger than 12 years with acute gastroenteritis did not show�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�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 �tag:www.gov.uk,2005:/drug-safety-update/adrenaline-auto-injectors-recent-action-taken-to-support-safety2019-10-18T15:39:58+01:00Adrenaline auto-injectors: recent action taken to support safetyHealthcare professionals should be aware of alerts and letters issued about adrenaline auto-injectors in September and October 2019. This article provides a summary of recent advice issued to healthcare professionals, includ�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/montelukast-singulair-reminder-of-the-risk-of-neuropsychiatric-reactions2019-09-19T11:40:35+01:00Montelukast (Singulair): reminder of the risk of neuropsychiatric reactionsPrescribers should be alert for neuropsychiatric reactions in patients taking montelukast and carefully consider the benefits and risks of continuing treatment if they occur.
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� (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�tag:www.gov.uk,2005:/drug-safety-update/medical-devices-alerts-issued-in-july-20192019-08-19T15:47:29+01:00 Medical Devices Alerts issued in July 2019Alerts were issued about Telefunken automated external defibrillators and BD Microtainer capillary blood specimen collection tubes. tag:www.gov.uk,2005:/drug-safety-update/tocilizumab-roactemra-rare-risk-of-serious-liver-injury-including-cases-requiring-transplantation2019-07-17T13:36:58+01:00Tocilizumab (RoActemra): rare risk of serious liver injury including cases requiring transplantationAlanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels should be measured before starting treatment with tocilizumab and monitored every 4�8 weeks for the first 6 months of treatment followed by every 12 �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�), Darzalex�(daratumumab), retinoids�, and febuxostat (Adenuric). A recall alert was issued for medicines that were taken out of the regul�