tag:www.gov.uk,2005:/drug-safety-updateDrug Safety Update about GI, hepatology and pancreatic disorders2024-10-24T11:00:11+01:00HM Governmenttag:www.gov.uk,2005:/drug-safety-update/letters-and-medicine-recalls-sent-to-healthcare-professionals-in-september-20242024-10-24T11:00:11+01:00Letters and medicine recalls sent to healthcare professionals in September 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-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-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-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/janus-kinase-jak-inhibitors-new-measures-to-reduce-risks-of-major-cardiovascular-events-malignancy-venous-thromboembolism-serious-infections-and-increased-mortality2023-04-26T11:39:39+01:00Janus kinase (JAK) inhibitors: new measures to reduce risks of major cardiovascular events, malignancy, venous thromboembolism, serious infections and increased mortalityWe inform healthcare professionals of new risk minimisation measures for JAK inhibitors used to treat chronic inflammatory disorders, consistent with the measures introduced for tofacitinib (Xeljanz) in 2020 and 2021. This a�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-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-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-may-20222022-06-20T16:38:29+01:00Letters and medicine recalls sent to healthcare professionals in May 2022A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devicestag:www.gov.uk,2005:/drug-safety-update/tofacitinib-xeljanzv-new-measures-to-minimise-risk-of-major-adverse-cardiovascular-events-and-malignancies2021-10-06T12:25:59+01:00Tofacitinib (Xeljanz�): new measures to minimise risk of major adverse cardiovascular events and malignanciesTofacitinib should not be used in patients older than 65 years of age, people who are current or past smokers, or individuals with other cardiovascular (such as diabetes or coronary artery disease) or malignancy risk factors�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/polyethylene-glycol-peg-laxatives-and-starch-based-thickeners-potential-interactive-effect-when-mixed-leading-to-an-increased-risk-of-aspiration2021-04-27T14:23:03+01:00Polyethylene glycol (PEG) laxatives and starch-based thickeners: potential interactive effect when mixed, leading to an increased risk of aspiration Addition of a polyethylene glycol (PEG)-based laxative to a liquid that has been thickened with a starch-based thickener may counteract the thickening action, placing patients with dysphagia at a greater risk of aspiration.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/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-december-20202021-01-07T11:00:06+00:00Letters and drug alerts sent to healthcare professionals in December 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-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/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/letters-and-drug-alerts-sent-to-healthcare-professionals-in-february-20202020-03-18T14:23:59+00:00Letters and drug alerts sent to healthcare professionals in February 2020 Letters were sent on Typhim Vi vaccines, Mepact (mifamurtide), and Xeljanz (tofacitinib) and an alert issued to recall Emerade 150 microgram adrenaline pens. tag:www.gov.uk,2005:/drug-safety-update/medical-device-alerts-issued-in-january-20202020-02-12T16:42:52+00:00Medical Device Alerts issued in January 2020Alerts were issued about Convex two-piece skin barriers for use with ostomy bags and HeartStart XL+ defibrillators. A notice was also issued following reports of falsely depressed creatinine results for patients on phenindio�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/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/carfilzomib-kyprolis-risk-of-reactivation-of-hepatitis-b-virus2019-11-21T14:57:06+00:00Carfilzomib (Kyprolis�): risk of reactivation of hepatitis B virusEstablish hepatitis B status before initiating carfilzomib and in patients with unknown hepatitis B virus serology who are already being treated with carfilzomib.
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/nivolumab-opdivo-reports-of-cytomegalovirus-cmv-gastrointestinal-infection-or-reactivation2019-10-18T15:40:33+01:00Nivolumab (Opdivo): reports of cytomegalovirus (CMV) gastrointestinal infection or reactivationPatients on nivolumab 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 infection�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/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/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/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-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/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/onivyde-irinotecan-liposomal-formulations-reports-of-serious-and-fatal-thromboembolic-events2019-03-21T11:49:57+00:00Onivyde (irinotecan, liposomal formulations): reports of serious and fatal thromboembolic eventsOnivyde has been associated with reports of serious thromboembolic events, such as pulmonary embolism, venous thrombosis, and arterial thromboembolism. tag:www.gov.uk,2005:/drug-safety-update/carbimazole-risk-of-acute-pancreatitis2019-02-20T08:51:30+00:00 Carbimazole: risk of acute pancreatitisIf acute pancreatitis occurs during treatment with carbimazole, immediately and permanently stop treatment. Re-exposure to carbimazole may result in life-threatening acute pancreatitis with a decreased time to onset.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� (olaratumab), quadrivalent influenza vaccine (split virion, inactivated), SGLT2 inhibitors, and carbimazole and thiamazole (synonym: methimazole)-containing produ�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/direct-acting-antivirals-for-chronic-hepatitis-c-risk-of-hypoglycaemia-in-patients-with-diabetes2018-12-18T12:43:45+00:00Direct-acting antivirals for chronic hepatitis C: risk of hypoglycaemia in patients with diabetesMonitor glucose levels closely in patients with diabetes during direct-acting antiviral therapy for hepatitis C, particularly within the first 3 months of treatment, and modify diabetes medication or doses when necessary. Pa�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/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-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/esmya-ulipristal-acetate-and-risk-of-serious-liver-injury-new-restrictions-to-use-and-requirements-for-liver-function-monitoring-before-during-and-after-treatment2018-08-24T15:00:57+01:00Esmya (ulipristal acetate) and risk of serious liver injury: new restrictions to use and requirements for liver function monitoring before, during, and after treatmentMore than one treatment course is authorised only in women who are not eligible for surgery, and liver function monitoring is to be carried out in all women treated with Esmya. Before initiation, discuss with women the rare �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/eltrombopag-revolade-reports-of-interference-with-bilirubin-and-creatinine-test-results2018-07-17T14:37:13+01:00Eltrombopag (Revolade): reports of interference with bilirubin and creatinine test resultsIf bilirubin and/or creatinine test results are inconsistent with clinical observations, request re-testing using another method to determine the validity of the result.
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/medical-device-alerts-issued-in-may-20182018-06-22T12:47:42+01:00Medical Device Alerts issued in May 2018An alert was recently issued by MHRA on JM103 and JM105 Jaundice Meters. We also remind you of an alert about Accu-Chek blood glucose test strips.tag:www.gov.uk,2005:/drug-safety-update/obeticholic-acid-ocaliva-risk-of-serious-liver-injury-in-patients-with-pre-existing-moderate-or-severe-hepatic-impairment-reminder-to-adjust-dosing-according-to-liver-function-monitoring2018-04-24T09:04:32+01:00Obeticholic acid (Ocaliva�): risk of serious liver injury in patients with pre-existing moderate or severe hepatic impairment; reminder to adjust dosing according to liver function monitoring We are aware of reports of serious liver injuries and deaths in patients with primary biliary cholangitis with pre-existing moderate or severe liver impairment who were not adequately dose-adjusted. Follow dose reduction and�tag:www.gov.uk,2005:/drug-safety-update/esmya-ulipristal-acetate-for-uterine-fibroids-do-not-initiate-or-re-start-treatment-monitor-liver-function-in-current-and-recent-users2018-03-08T14:23:08+00:00Esmya (ulipristal acetate) for uterine fibroids: do not initiate or re-start treatment; monitor liver function in current and recent users Temporary safety measures are in place while an EU review investigates the link between cases of serious liver injury, including 4 cases requiring liver transplantation, and Esmya for uterine fibroids.