tag:www.gov.uk,2005:/drug-safety-updateDrug Safety Update about Immunosuppression and transplantation2024-05-29T14:32:40+01:00HM Governmenttag:www.gov.uk,2005:/drug-safety-update/letters-and-medicine-recalls-sent-to-healthcare-professionals-in-april-20242024-05-29T14:32:40+01:00Letters and medicine recalls sent to healthcare professionals in April 2024 A 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. The article also includ�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-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/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/letters-and-medicine-recalls-sent-to-healthcare-professionals-in-september-20222022-10-25T14:43:16+01:00Letters and medicine recalls sent to healthcare professionals in September 2022A 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-june-20222022-07-21T11:03:37+01:00Letters and medicine recalls sent to healthcare professionals in June 2022A summary of recent letters and notifications sent to healthcare professionals about medicines.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-drug-alerts-sent-to-healthcare-professionals-in-june-20202020-07-31T11:39:50+01:00Letters and drug alerts sent to healthcare professionals in June 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-may-20202020-06-29T15:19:54+01:00Letters and drug alerts sent to healthcare professionals in May 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-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/daratumumab-darzalex-risk-of-reactivation-of-hepatitis-b-virus2019-08-19T15:48:18+01:00 Daratumumab (Darzalex�): risk of reactivation of hepatitis B virusEstablish hepatitis B virus status before initiating daratumumab and in patients with unknown hepatitis B virus serology who are already being treated with daratumumab. 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/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�tag:www.gov.uk,2005:/drug-safety-update/lemtrada-alemtuzumab-and-serious-cardiovascular-and-immune-mediated-adverse-reactions-new-restrictions-to-use-and-strengthened-monitoring-requirements2019-05-17T14:56:02+01:00Lemtrada (alemtuzumab) and serious cardiovascular and immune-mediated adverse reactions: new restrictions to use and strengthened monitoring requirements While an urgent EU safety review evaluates reports of serious cardiovascular events and immune-mediated reactions, including autoimmune hepatitis, the use of alemtuzumab (Lemtrada) has been restricted and strengthened requir�tag:www.gov.uk,2005:/drug-safety-update/letters-and-drug-alerts-sent-to-healthcare-professionals-in-april-20192019-05-17T14:53:45+01:00Letters and drug alerts sent to healthcare professionals in April 2019Letters were sent about alemtuzumab (Lemtrada), Selenase (sodium selenite pentahydrate), and Erelzi� (etanercept). tag:www.gov.uk,2005:/drug-safety-update/yellow-fever-vaccine-stamaril-and-fatal-adverse-reactions-extreme-caution-needed-in-people-who-may-be-immunosuppressed-and-those-60-years-and-older2019-04-16T15:54:26+01:00Yellow fever vaccine (Stamaril) and fatal adverse reactions: extreme caution needed in people who may be immunosuppressed and those 60 years and olderWe have recently received 2 reports of fatal adverse reactions to the yellow fever vaccine (Stamaril). Due to an increased risk of life-threatening reactions, the vaccine must not be given to anyone with a medical history of�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/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�tag:www.gov.uk,2005:/drug-safety-update/ipilimumab-yervoy-reports-of-cytomegalovirus-cmv-gastrointestinal-infection-or-reactivation2019-01-09T16:30:50+00:00Ipilimumab (Yervoy): reports of cytomegalovirus (CMV) gastrointestinal infection or reactivation Patients on ipilimumab who present with diarrhoea or other symptoms of colitis, and those who do not respond to steroid treatment for immune-related colitis, should be investigated to exclude other causes, including infectio�tag:www.gov.uk,2005:/drug-safety-update/letters-and-drug-alerts-sent-to-healthcare-professionals-in-december-20182019-01-09T16:30:20+00:00Letters and drug alerts sent to healthcare professionals in December 2018In December 2018, a letter was sent to notify healthcare professionals of the discontinuation of Zovirax (Aciclovir) eye ointment. We also highlight the recent recall of Actavis batches of irbesartan/hydrochlorothiazide tabl�tag:www.gov.uk,2005:/drug-safety-update/ritonavir-containing-products-reports-of-interaction-with-levothyroxine-leading-to-reduced-thyroxine-levels2018-10-11T11:29:14+01:00 Ritonavir-containing products: reports of interaction with levothyroxine leading to reduced thyroxine levelsMonitor thyroid-stimulating hormone (TSH) in patients treated with levothyroxine for at least the first month after starting and ending ritonavir treatment.tag:www.gov.uk,2005:/drug-safety-update/letters-and-drug-alerts-sent-to-healthcare-professionals-in-august-20182018-09-25T14:01:36+01:00Letters and drug alerts sent to healthcare professionals in August 2018Letters were sent about daclizumab beta (Zinbryta�), alteplase (Actilyse), Esmya (ulipristal acetate), and Xofigo� (radium-223-dichloride). MHRA issued alerts and recalls for batches of Nutriflex Omega Special 2500 ml and Nu�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/parenteral-amphotericin-b-reminder-of-risk-of-potentially-fatal-adverse-reaction-if-formulations-confused2018-07-17T14:36:28+01:00Parenteral amphotericin B: reminder of risk of potentially fatal adverse reaction if formulations confusedFollowing receipt of a third case of fatal medication error caused by the administration of Fungizone (a non-lipid-based formulation of amphotericin B) instead of a lipid-based formulation (AmBisome, Abelcet), we remind heal�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/letters-sent-to-healthcare-professionals-in-june-20182018-07-17T14:33:45+01:00Letters sent to healthcare professionals in June 2018Letters were sent about Cetrotide (cetrorelix acetate), Eperzan�(albiglutide), darunavir/cobicistat, Keytruda� (pembrolizumab), Denzapine (clozapine) 50 mg/mL oral suspension, and Bleo-Kyowa (bleomycin sulphate).tag:www.gov.uk,2005:/drug-safety-update/letters-sent-to-healthcare-professionals-in-may-20182018-06-22T12:47:55+01:00Letters sent to healthcare professionals in May 2018Letters were sent about azithromycin, Lynparza�(Olaparib), Xgeva� (denosumab), Lymphoseek (tilmanocept), ReoPro (abciximab) and dolutegravir; you still have time to complete a quick survey to tell us your views on the way me�tag:www.gov.uk,2005:/drug-safety-update/letters-sent-to-healthcare-professionals-in-february-20182018-03-08T14:21:23+00:00Letters sent to healthcare professionals in February 2018Letters were sent about ellaOne, ERWINASE, Eperzan�, Ocaliva�, Velcade, Esmya, and Bleo-Kyowa.tag:www.gov.uk,2005:/drug-safety-update/mycophenolate-mofetil-mycophenolic-acid-updated-contraception-advice-for-male-patients2018-02-06T16:59:45+00:00Mycophenolate mofetil, mycophenolic acid: updated contraception advice for male patientsMycophenolate mofetil and its active metabolite mycophenolic acid, both used to prevent transplant rejection, are teratogenic and genotoxic. The available clinical evidence does not indicate an increased risk of malformation�tag:www.gov.uk,2005:/drug-safety-update/letters-sent-to-healthcare-professionals-in-january-20182018-02-06T16:59:25+00:00Letters sent to healthcare professionals in January 2018Letters were sent about Buccolam (midazolam), misoprostol vaginal delivery system (Mysodelle), noradrenaline, Relenza (zanamivir), mycophenolate mofetil/mycophenolic acid, Flolan, and Fludara. tag:www.gov.uk,2005:/drug-safety-update/oral-tacrolimus-products-reminder-to-prescribe-and-dispense-by-brand-name-only2017-11-24T11:09:10+00:00Oral tacrolimus products: reminder to prescribe and dispense by brand name onlyInadvertent switching between tacrolimus products has been associated with reports of toxicity and graft rejection. If you switch a patient to a different brand, ensure they receive careful supervision and therapeutic monito�tag:www.gov.uk,2005:/drug-safety-update/updates-to-public-health-england-s-green-book-chapter-on-live-attenuated-vaccines2017-11-24T11:06:45+00:00Updates to Public Health England’s Green Book chapter on live attenuated vaccinesFurther to our previous advice in 2016, Public Health England have updated their guidance about live vaccination of infants born to a mother who received immunosuppressive biological therapy during pregnancy.tag:www.gov.uk,2005:/drug-safety-update/nivolumab-opdivo-pembrolizumab-keytruda-reports-of-organ-transplant-rejection2017-07-20T15:29:45+01:00Nivolumab (Opdivo�), pembrolizumab (Keytruda�): reports of organ transplant rejection There have been reports of rejection of solid organ transplants in patients treated with nivolumab or pembrolizumab. Ipilimumab (Yervoy�) may also interfere with immunosuppressive therapy, increasing the risk of graft reject�tag:www.gov.uk,2005:/drug-safety-update/letters-sent-to-healthcare-professionals-in-march-20172017-04-24T10:26:27+01:00Letters sent to healthcare professionals in March 2017A summary of letters sent to relevant healthcare professionals.tag:www.gov.uk,2005:/drug-safety-update/direct-acting-antiviral-interferon-free-regimens-to-treat-chronic-hepatitis-c-risk-of-hepatitis-b-reactivation2017-01-19T11:56:15+00:00Direct-acting antiviral interferon-free regimens to treat chronic hepatitis C: risk of hepatitis B reactivationAll patients should be screened for hepatitis B before starting treatment for chronic hepatitis C with direct-acting antiviral interferon-free regimens. Patients who are co-infected with hepatitis B and C viruses are at risk�tag:www.gov.uk,2005:/drug-safety-update/cobicistat-ritonavir-and-coadminsitration-with-a-steroid-risk-of-systemic-corticosteroid-adverse-effects2016-12-14T11:28:40+00:00Cobicistat, ritonavir and coadministration with a steroid: risk of systemic corticosteroid adverse effects Coadministration of a corticosteroid with an HIV-treatment-boosting agent may increase the risk of adrenal suppression due to a pharmacokinetic interaction. tag:www.gov.uk,2005:/drug-safety-update/letters-sent-to-healthcare-professionals-in-november-20162016-12-14T11:27:59+00:00Letters sent to healthcare professionals in November 2016A summary of recent letters sent to relevant healthcare professionals, to inform them of updated safety information.tag:www.gov.uk,2005:/drug-safety-update/bcr-abl-tyrosine-kinase-inhibitors-risk-of-hepatitis-b-reactivation2016-05-10T15:31:14+01:00BCR-ABL tyrosine kinase inhibitors: risk of hepatitis B reactivationPatients should be tested for hepatitis B virus before starting treatment with BCR-ABL tyrosine kinase inhibitors.tag:www.gov.uk,2005:/drug-safety-update/pomalidomide-imnovid-risk-of-hepatitis-b-reactivation2016-05-10T15:30:50+01:00Pomalidomide (Imnovid�): risk of hepatitis B reactivationBefore starting treatment with pomalidomide, establish hepatitis B virus status in all patients. tag:www.gov.uk,2005:/drug-safety-update/live-attenuated-vaccines-avoid-use-in-those-who-are-clinically-immunosuppressed2016-04-18T13:43:57+01:00Live attenuated vaccines: avoid use in those who are clinically immunosuppressedHealthcare professionals working in primary and secondary care should ensure that clinically significant immunosuppression in a patient is identified before administration of a live attenuated vaccine.tag:www.gov.uk,2005:/drug-safety-update/mycophenolate-mofetil-mycophenolic-acid-new-pregnancy-prevention-advice-for-women-and-men2015-12-14T16:18:48+00:00Mycophenolate mofetil, mycophenolic acid: new pregnancy-prevention advice for women and menMycophenolate mofetil and its active metabolite mycophenolic acid are associated with a high rate of serious birth defects and increased risk of spontaneous abortion.tag:www.gov.uk,2005:/drug-safety-update/letters-sent-to-healthcare-professionals-in-november-20152015-12-14T16:17:27+00:00Letters sent to healthcare professionals in November 2015In November, letters were sent regarding thalidomide, mycophenolate mofetil, nicorandil, InductOs, and dimethyl fumaratetag:www.gov.uk,2005:/drug-safety-update/letters-sent-to-healthcare-professionals-in-april-20152015-05-20T12:51:05+01:00Letters sent to healthcare professionals in April 2015Last month, letters were sent regarding ketoprofen gel, fingolimod (Gilenya�) and efavirenz (Sustiva).tag:www.gov.uk,2005:/drug-safety-update/dimethyl-fumarate-tecfidera-fatal-pml-in-a-ms-patient-with-severe-prolonged-lymphopenia2015-03-30T12:02:50+01:00Dimethyl fumarate (Tecfidera): fatal PML in an MS patient with severe, prolonged lymphopeniaCheck full blood counts before prescribing dimethyl fumarate and then every 6 to 12 months. Stop treatment immediately if you suspect progressive multifocal leukoencephalopathy.tag:www.gov.uk,2005:/drug-safety-update/corticosteroids-e-learning-module-launched2015-03-30T11:57:32+01:00Corticosteroids e-learning module launched The new module helps clinicians understand how to identify, manage and avoid side effects when using corticosteroids.tag:www.gov.uk,2005:/drug-safety-update/mycophenolate-mofetil-cellcept-and-mycophenolic-acid-risk-of-hypogammaglobulinaemia-and-risk-of-bronchiectasis2015-01-22T15:08:32+00:00Mycophenolate mofetil (CellCept) and mycophenolic acid: risk of hypogammaglobulinaemia and risk of bronchiectasisMeasure serum immunoglobulin levels if recurrent infections develop. Consider bronchiectasis or pulmonary fibrosis if patients develop persistent respiratory symptoms.tag:www.gov.uk,2005:/drug-safety-update/basiliximab-indicated-for-renal-transplantation-only-efficacy-and-safety-not-shown-in-heart-transplantation2014-12-11T14:37:55+00:00Basiliximab: indicated for renal transplantation only; efficacy and safety not shown in heart transplantation Basiliximab (Simulect) is indicated for preventing acute organ rejection only for allogeneic renal transplantation in patients receiving organ transplantation for the first time.tag:www.gov.uk,2005:/drug-safety-update/fingolimod-gilenya-bradycardia-and-heart-block2014-12-11T14:34:12+00:00Fingolimod (Gilenya�): bradycardia and heart block Repeat enhanced cardiovascular monitoring when restarting fingolimod after treatment interruption,tag:www.gov.uk,2005:/drug-safety-update/reporting-suspected-adverse-drug-reactions-to-vaccines-and-biological-medicines2014-12-11T14:34:00+00:00Reporting suspected adverse drug reactions to vaccines and biological medicinesThe non-identical nature of biological medicines and vaccines means it is very important that safety surveillance is carried out on a brand/product-specific basis.