tag:www.gov.uk,2005:/drug-safety-updateDrug Safety Update about Urology and nephrology2024-08-21T11:00:45+01:00HM Governmenttag:www.gov.uk,2005:/drug-safety-update/yellow-card-biobank-call-to-contribute-to-study-of-genetic-links-to-side-effects2024-08-21T11:00:45+01:00Yellow Card Biobank: call to contribute to study of genetic links to side effectsSupport this initiative to explore whether there is a genetic basis of side effects associated with direct-acting oral anticoagulants (DOACs) and allopurinol. tag:www.gov.uk,2005:/drug-safety-update/finasteride-reminder-of-the-risk-psychiatric-side-effects-and-of-sexual-side-effects-which-may-persist-after-discontinuation-of-treatment2024-04-29T16:03:17+01:00Finasteride: reminder of the risk psychiatric side effects and of sexual side effects (which may persist after discontinuation of treatment)A patient alert card is being introduced for men taking finasteride to help raise awareness of the risk of psychiatric side effects and sexual dysfunction, including the potential for sexual dysfunction to persist after trea�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-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-july-20232023-08-30T10:31:08+01:00Letters and medicine recalls sent to healthcare professionals in July 2023A summary of recent letters and notifications sent to healthcare professionals about medicines.tag:www.gov.uk,2005:/drug-safety-update/nitrofurantoin-reminder-of-the-risks-of-pulmonary-and-hepatic-adverse-drug-reactions2023-04-26T11:39:28+01:00Nitrofurantoin: reminder of the risks of pulmonary and hepatic adverse drug reactionsHealthcare professionals prescribing nitrofurantoin should be alert to the risks of pulmonary and hepatic adverse drug reactions and advise patients to be vigilant for the signs and symptoms in need of further investigation. tag:www.gov.uk,2005:/drug-safety-update/xaqua-metolazone-5mg-tablets-exercise-caution-when-switching-patients-between-metolazone-preparations2023-01-25T13:25:19+00:00Xaqua (metolazone) 5mg tablets: exercise caution when switching patients between metolazone preparationsPrescribers and dispensers should use caution if switching patients between different metolazone preparations as the rate and extent of absorption of metolazone are formulation dependent. This can impact the bioavailability �tag:www.gov.uk,2005:/drug-safety-update/letters-and-medicine-recalls-sent-to-healthcare-professionals-in-december-20222023-01-25T13:24:51+00:00Letters and medicine recalls sent to healthcare professionals in December 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-august-20222022-09-26T16:19:15+01:00Letters and medicine recalls sent to healthcare professionals in August 2022A summary of recent letters and notifications sent to healthcare professionals about medicinestag: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-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/letters-and-drug-alerts-sent-to-healthcare-professionals-in-february-20212021-03-24T14:27:38+00:00Letters and drug alerts sent to healthcare professionals in February 2021A 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-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-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-december-20192020-01-27T15:32:31+00:00Medical Device Alerts issued in December 2019Alerts were issued about Arrow EZ-IO intraosseous vascular access needle sets, Medicina IV Luer Slip syringes, and Spectra Optia apheresis systems. 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/prescribing-medicines-in-renal-impairment-using-the-appropriate-estimate-of-renal-function-to-avoid-the-risk-of-adverse-drug-reactions2019-10-18T15:40:17+01:00Prescribing medicines in renal impairment: using the appropriate estimate of renal function to avoid the risk of adverse drug reactionsFor most patients and most medicines, estimated Glomerular Filtration Rate (eGFR) is an appropriate measure of renal function for determining dosage adjustments in renal impairment; however, in some circumstances, the Cockcr�tag:www.gov.uk,2005:/drug-safety-update/elmiron-pentosan-polysulfate-sodium-rare-risk-of-pigmentary-maculopathy2019-09-19T11:40:49+01:00Elmiron (pentosan polysulfate sodium): rare risk of pigmentary maculopathyCases of pigmentary maculopathy leading to visual impairment have been reported with pentosan polysulfate, particularly after long-term use at high doses. Ensure patients taking pentosan polysulfate have regular ophthalmic e�tag:www.gov.uk,2005:/drug-safety-update/letters-and-drug-alerts-sent-to-healthcare-professionals-in-august-20192019-09-19T11:40:19+01:00Letters and drug alerts sent to healthcare professionals in August 2019A letter was sent to advise healthcare professionals about a restriction to the indication and route of administration for Mitomycin-C Kyowa 40 mg following the observation of increased sub-visible particles in the drug prod�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/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�tag:www.gov.uk,2005:/drug-safety-update/medical-device-alerts-issued-in-june-20192019-07-17T13:34:20+01:00Medical Device Alerts issued in June 2019An alert was issued about Dialog+ haemodialysis machines.tag:www.gov.uk,2005:/drug-safety-update/belimumab-benlysta-increased-risk-of-serious-psychiatric-events-seen-in-clinical-trials2019-04-16T15:53:56+01:00Belimumab (Benlysta�): increased risk of serious psychiatric events seen in clinical trialsClinical trials, including interim findings from a randomised trial, show an increased risk of depression, suicidal ideation or behaviour, or self-injury in patients with systemic lupus erythematosus receiving belimumab comp�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� (tofacitinib), ranitidine, Nulojix (belatacept), fluoroquinolone antibiotics, Genvoya�, Stribild�, Tybost, and belimumab (Benlysta�). Drug alerts were issued about Accord losartan potassium c�tag:www.gov.uk,2005:/drug-safety-update/medical-device-alerts-issued-in-march-20192019-04-16T15:53:15+01:00Medical Device Alerts issued in March 2019Alerts were issued about Pagewriter Cardiographs and Efficia Monitors and Fresenius 5008 & 5008S haemodialysis machines.
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/sglt2-inhibitors-reports-of-fournier-s-gangrene-necrotising-fasciitis-of-the-genitalia-or-perineum2019-02-20T08:51:21+00:00SGLT2 inhibitors: reports of Fournier’s gangrene (necrotising fasciitis of the genitalia or perineum) If Fournier’s gangrene is suspected, stop the SGLT2 inhibitor and start treatment urgently (including antibiotics and surgical debridement). Fournier’s gangrene is a rare but potentially life-threatening infection that requi�tag:www.gov.uk,2005:/drug-safety-update/medical-device-alerts-issued-in-november-20182018-12-18T12:42:26+00:00Medical Device Alerts issued in November 2018Alerts were issued about ConvaTec Suction catheters, gastro-enteral tubes, intermittent urology catheters and sterile urine drainage bags, CME T34 ambulatory syringe pumps, and HeartStart MRx monitor/defibrillators.tag:www.gov.uk,2005:/drug-safety-update/hydrochlorothiazide-risk-of-non-melanoma-skin-cancer-particularly-in-long-term-use2018-11-14T11:51:04+00:00Hydrochlorothiazide: risk of non-melanoma skin cancer, particularly in long-term useAdvise patients taking hydrochlorothiazide-containing products of the cumulative, dose-dependent risk of non-melanoma skin cancer, particularly in long-term use, and the need to regularly check for (and report) any suspiciou�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/letters-and-drug-alerts-sent-to-healthcare-professionals-in-october-20182018-11-14T11:48:53+00:00Letters and drug alerts sent to healthcare professionals in October 2018Letters were sent to healthcare professionals about Jext adrenaline autoinjectors, rivaroxaban, Ozurdex 700 micrograms intravitreal implant, sildenafil, hydrochlorothiazide, and Epilim Chronosphere (sodium valproate). We als�tag:www.gov.uk,2005:/drug-safety-update/letters-and-drug-alerts-sent-to-healthcare-professionals-in-september-20182018-10-11T11:27:55+01:00Letters and drug alerts sent to healthcare professionals in September 2018A supply disruption alert was issued by the Department of Health & Social Care (DHSC) on EpiPen and EpiPen Junior; see MHRA advice on extension of use beyond the expiry date for certain batches of EpiPen 300 microgram ad�tag:www.gov.uk,2005:/drug-safety-update/xofigo-radium-223-dichloride-new-restrictions-on-use-due-to-increased-risk-of-fracture-and-trend-for-increased-mortality-seen-in-clinical-trial2018-09-25T14:03:27+01:00Xofigo� (radium-223-dichloride): new restrictions on use due to increased risk of fracture and trend for increased mortality seen in clinical trial Now only authorised for use in patients with symptomatic bone metastases and no known visceral metastases who have had 2 previous systemic treatments for metastatic castration-resistant prostate cancer or who cannot receive �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/letters-and-drug-alerts-sent-to-healthcare-professionals-in-july-20182018-08-24T14:56:18+01:00Letters and drug alerts sent to healthcare professionals in July 2018Letters were sent about valproate medicines, atezolizumab (Tecentriq�), and nusinersen (Spinraza�). MHRA issued alerts and recalls for valsartan-containing medicines, Fiasp FlexTouch pre-filled pens, melatonin capsules, and �tag:www.gov.uk,2005:/drug-safety-update/medical-device-alerts-issued-in-july-20182018-08-24T14:54:33+01:00Medical Device Alerts issued in July 2018Alerts were recently issued about Novaline haemodialysis bloodlines used with Baxter/Gambro haemodialysis machines and Alaris and Asena enteral syringe pumps 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/medical-device-alerts-issued-in-june-20182018-07-17T14:32:32+01:00Medical Device Alerts issued in June 2018Alerts were recently issued by MHRA about Smiths Medical medication cassette reservoirs, Alaris Smartsite add-on bag access devices, and Combur10 Test UX and Chemstrip 10 A urinalysis test strips. tag:www.gov.uk,2005:/drug-safety-update/medical-device-alerts-issued-in-april-2018-recent-alert-about-accu-chek-blood-glucose-test-strips2018-05-24T14:16:33+01:00Medical Device Alerts issued in April 2018; recent alert about Accu-Chek blood glucose test stripsAn alert was issued recently about Accu-Chek Aviva, Accu-Chek Performa, and Accu-Chek Inform II test strips � risk of strip error messages and false high and low blood glucose results. An alert was also issued recently about�tag:www.gov.uk,2005:/drug-safety-update/medical-device-alerts-issued-in-march-20182018-04-24T09:01:02+01:00Medical Device Alerts issued in March 2018An alert was issued about T34 ambulatory syringe pumps.
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/medical-device-alerts-issued-in-february-20182018-03-08T14:21:11+00:00Medical Device Alerts issued in February 2018Alerts were recently issued about RUSCH rectal/pharyngeal temperature sensors and Aquilon nebulisers. 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/recombinant-human-erythropoietins-very-rare-risk-of-severe-cutaneous-adverse-reactions-scars2018-01-09T10:27:04+00:00Recombinant human erythropoietins: very rare risk of severe cutaneous adverse reactions (SCARs)Recombinant human erythropoietin (r-HuEPO) treatment has been associated with very rare cases of life-threatening severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome (SJS) and toxic epidermal necro�