tag:www.gov.uk,2005:/drug-safety-updateDrug Safety Update about Rheumatology2024-10-24T11:00:11+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/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/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/methotrexate-advise-patients-to-take-precautions-in-the-sun-to-avoid-photosensitivity-reactions2023-08-30T10:31:17+01:00Methotrexate: advise patients to take precautions in the sun to avoid photosensitivity reactionsPhotosensitivity reactions are known side effects of methotrexate treatment and can be severe. Patients should be advised to take precautions to protect their skin in the sun.tag:www.gov.uk,2005:/drug-safety-update/febuxostat-updated-advice-for-the-treatment-of-patients-with-a-history-of-major-cardiovascular-disease2023-05-25T10:53:22+01:00Febuxostat: updated advice for the treatment of patients with a history of major cardiovascular disease Caution is required if prescribing febuxostat in patients with pre-existing major cardiovascular disease, particularly, in those with evidence of high urate crystal and tophi burden or those initiating urate-lowering therapy�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-march-20232023-04-26T11:39:21+01:00Letters and medicine recalls sent to healthcare professionals in March 2023 A 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-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/denosumab-60mg-prolia-should-not-be-used-in-patients-under-18-years-due-to-the-risk-of-serious-hypercalcaemia2022-05-17T13:11:57+01:00Denosumab 60mg (Prolia): should not be used in patients under 18 years due to the risk of serious hypercalcaemiaSerious and life-threatening hypercalcaemia has been reported with denosumab 60mg (Prolia) in children and adolescents in clinical trials for osteogenesis imperfecta and during off-label use. Denosumab 60mg (Prolia) is autho�tag:www.gov.uk,2005:/drug-safety-update/letters-and-medicine-recalls-sent-to-healthcare-professionals-in-april-20222022-05-17T13:11:33+01:00Letters and medicine recalls sent to healthcare professionals in April 2022A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices. Includes a recent recall of Accupro (quinapril hydrochloride) and advice on Xagrid (anagrelide hydrochloride�tag:www.gov.uk,2005:/drug-safety-update/hydroxychloroquine-chloroquine-increased-risk-of-cardiovascular-events-when-used-with-macrolide-antibiotics-reminder-of-psychiatric-reactions2022-02-15T14:06:36+00:00Hydroxychloroquine, chloroquine: increased risk of cardiovascular events when used with macrolide antibiotics; reminder of psychiatric reactions Carefully consider the benefits and risks before prescribing systemic azithromycin or other systemic macrolide antibiotics (erythromycin or clarithromycin) to patients being treated with hydroxychloroquine or chloroquine. An�tag:www.gov.uk,2005:/drug-safety-update/letters-and-medicine-recalls-sent-to-healthcare-professionals-in-december-20212022-01-18T13:18:06+00:00Letters and medicine recalls sent to healthcare professionals in December 2021A summary of recent letters, medicine recalls and notifications sent to healthcare professionals.tag: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/methotrexate-once-weekly-for-autoimmune-diseases-new-measures-to-reduce-risk-of-fatal-overdose-due-to-inadvertent-daily-instead-of-weekly-dosing2020-09-23T14:28:01+01:00Methotrexate once-weekly for autoimmune diseases: new measures to reduce risk of fatal overdose due to inadvertent daily instead of weekly dosingIn autoimmune conditions and some cancer therapies, methotrexate should be taken once a week; however, we continue to receive reports of inadvertent overdose due to more frequent dosing (including daily administration). New �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/denosumab-60mg-prolia-increased-risk-of-multiple-vertebral-fractures-after-stopping-or-delaying-ongoing-treatment2020-08-26T14:08:54+01:00Denosumab 60mg (Prolia): increased risk of multiple vertebral fractures after stopping or delaying ongoing treatmentEvaluate a patient’s individual factors for benefits and risks before initiating treatment with denosumab 60mg, particularly in those with previous vertebral fracture. Patients should not stop denosumab without specialist re�tag:www.gov.uk,2005:/drug-safety-update/baricitinib-olumiant-increased-risk-of-diverticulitis-particularly-in-patients-with-risk-factors2020-08-26T14:08:31+01:00Baricitinib (Olumiant�): increased risk of diverticulitis, particularly in patients with risk factors Use baricitinib with caution in patients with diverticular disease and in those concomitantly treated with medications associated with an increased risk of diverticulitis.
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/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/tofacitinib-xeljanz-new-measures-to-minimise-risk-of-venous-thromboembolism-and-of-serious-and-fatal-infections2020-03-18T14:25:35+00:00Tofacitinib (Xeljanz�): new measures to minimise risk of venous thromboembolism and of serious and fatal infections Caution should be used in patients with known risk factors for venous thromboembolism in addition to the underlying disease. Patients older than 65 years of age are at an increased risk of serious infections and should be tr�tag:www.gov.uk,2005:/drug-safety-update/baricitinib-olumiant-risk-of-venous-thromboembolism2020-03-18T14:25:18+00:00Baricitinib (Olumiant�): risk of venous thromboembolism Discontinue baricitinib treatment permanently if clinical features of deep vein thrombosis or pulmonary embolism occur. Prescribers are reminded to use caution if using baricitinib in patients with risk factors for deep vein�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/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/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/febuxostat-adenuric-increased-risk-of-cardiovascular-death-and-all-cause-mortality-in-clinical-trial-in-patients-with-a-history-of-major-cardiovascular-disease2019-07-17T13:37:31+01:00Febuxostat (Adenuric): increased risk of cardiovascular death and all-cause mortality in clinical trial in patients with a history of major cardiovascular diseaseAvoid treatment with febuxostat in patients with pre-existing major cardiovascular disease (for example, myocardial infarction, stroke, or unstable angina), unless no other therapy options are appropriate. Findings from a ph�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/direct-acting-oral-anticoagulants-doacs-increased-risk-of-recurrent-thrombotic-events-in-patients-with-antiphospholipid-syndrome2019-06-19T14:15:12+01:00Direct-acting oral anticoagulants (DOACs): increased risk of recurrent thrombotic events in patients with antiphospholipid syndromeA clinical trial has shown an increased risk of recurrent thrombotic events associated with rivaroxaban compared with warfarin, in patients with antiphospholipid syndrome and a history of thrombosis. Other direct-acting oral�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�: 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�tag:www.gov.uk,2005:/drug-safety-update/tofacitinib-xeljanz-restriction-of-10-mg-twice-daily-dose-in-patients-at-high-risk-of-pulmonary-embolism-while-safety-review-is-ongoing2019-05-17T14:55:22+01:00Tofacitinib (Xeljanz�): restriction of 10 mg twice-daily dose in patients at high risk of pulmonary embolism while safety review is ongoing Following observation in a clinical study of an increased risk of pulmonary embolism and overall mortality with tofacitinib 10 mg twice-daily in rheumatoid arthritis, a safety review has started and new contraindications int�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/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/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/emollients-new-information-about-risk-of-severe-and-fatal-burns-with-paraffin-containing-and-paraffin-free-emollients2018-12-18T12:44:10+00:00Emollients: new information about risk of severe and fatal burns with paraffin-containing and paraffin-free emollientsWarnings about the risk of severe and fatal burns are being extended to all paraffin-based emollients regardless of paraffin concentration. Data suggest there is also a risk for paraffin-free emollients. Advise patients who �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/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/co-dydramol-prescribe-and-dispense-by-strength-to-minimise-risk-of-medication-error2018-01-09T10:26:37+00:00Co-dydramol: prescribe and dispense by strength to minimise risk of medication errorPreviously co-dydramol (dihydrocodeine/paracetamol) was available only in the ratio 1:50 (co-dydramol 10/500 mg). Two products are now available with a higher strength of dihydrocodeine (co-dydramol 20/500 mg and 30/500 mg t�tag:www.gov.uk,2005:/drug-safety-update/corticosteroids-rare-risk-of-central-serous-chorioretinopathy-with-local-as-well-as-systemic-administration2017-08-15T09:23:11+01:00Corticosteroids: rare risk of central serous chorioretinopathy with local as well as systemic administrationCentral serous chorioretinopathy is a retinal disorder that has been linked to the systemic use of corticosteroids. Recently, it has also been reported after local administration of corticosteroids via inhaled and intranasal�tag:www.gov.uk,2005:/drug-safety-update/apremilast-otezla-risk-of-suicidal-thoughts-and-behaviour2017-01-19T11:55:03+00:00Apremilast (Otezla �): risk of suicidal thoughts and behaviourThere is an increased risk that some patients may experience psychiatric symptoms with apremilast, including depression and suicidal thoughts. Stop treatment if patients have new psychiatric symptoms or if existing symptoms �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/etoricoxib-arcoxia-revised-dose-recommendation-for-rheumatoid-arthritis-and-ankylosing-spondylitis2016-10-17T12:52:38+01:00Etoricoxib (Arcoxia): revised dose recommendation for rheumatoid arthritis and ankylosing spondylitisPrescribing information has been updated to introduce a lower recommended dose of 60 mg daily for patients with rheumatoid arthritis or ankylosing spondylitis.tag:www.gov.uk,2005:/drug-safety-update/letters-sent-to-healthcare-professionals-in-september-2016-including-retigabine-withdrawal2016-10-17T12:52:11+01:00Letters sent to healthcare professionals in September 2016, including retigabine withdrawalA summary of letters sent to healthcare professionals in September 2016, including important information for professionals who specialise in epilepsy treatment regarding the withdrawal from the market of retigabine (Trobalt).tag:www.gov.uk,2005:/drug-safety-update/meprobamate-licence-to-be-cancelled2016-04-18T13:43:41+01:00Meprobamate: licence to be cancelled Following an EU wide review of meprobamate, the remaining licence holder in the UK has ceased manufacturing and the licence will be cancelled by the end of 2016. tag:www.gov.uk,2005:/drug-safety-update/bisphosphonates-very-rare-reports-of-osteonecrosis-of-the-external-auditory-canal2015-12-14T16:18:16+00:00Bisphosphonates: very rare reports of osteonecrosis of the external auditory canalOsteonecrosis of the external auditory canal has been reported very rarely (fewer than 1 in 10 000 patients) with bisphosphonates, mainly in association with long-term therapy (2 years or longer).tag:www.gov.uk,2005:/drug-safety-update/denosumab-xgeva-prolia-intravenous-bisphosphonates-osteonecrosis-of-the-jaw-further-measures-to-minimise-risk2015-07-20T11:59:37+01:00Denosumab (Xgeva�, Prolia); intravenous bisphosphonates: osteonecrosis of the jaw—further measures to minimise risk Patient reminder cards about the risk of osteonecrosis of the jaw are being introduced; denosumab 120 mg is now contraindicated in patients with unhealed lesions from dental or oral surgery.tag:www.gov.uk,2005:/drug-safety-update/high-dose-ibuprofen-2400mg-day-small-increase-in-cardiovascular-risk2015-06-26T11:16:46+01:00High-dose ibuprofen (�2400mg/day): small increase in cardiovascular riskEU review confirms that the cardiovascular risk of high-dose ibuprofen (�2400mg/day) is similar to COX 2 inhibitors and diclofenac.