tag:www.gov.uk,2005:/drug-safety-updateDrug Safety Update about Pain management and palliation2025-03-12T11:02:10+00:00HM Governmenttag:www.gov.uk,2005:/drug-safety-update/prolonged-release-opioids-removal-of-indication-for-relief-of-post-operative-pain2025-03-12T11:02:10+00:00Prolonged-release opioids: Removal of indication for relief of post-operative painThe indication for the treatment of post-operative pain has been removed from the licences of all prolonged release opioids due to the increased risk of persistent post-operative opioid use (PPOU) and opioid-induced ventilat鈥�tag: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-june-20242024-07-23T14:01:07+01:00Letters and medicine recalls sent to healthcare professionals in June 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/warfarin-be-alert-to-the-risk-of-drug-interactions-with-tramadol2024-06-20T11:11:09+01:00Warfarin: be alert to the risk of drug interactions with tramadolTaking warfarin and tramadol together can cause harmful drug interactions, which can raise the International Normalised Ratio (INR), and result in severe bruising and bleeding, which in some patients could be fatal.tag:www.gov.uk,2005:/drug-safety-update/codeine-linctus-codeine-oral-solutions-reclassification-to-prescription-only-medicine2024-02-20T11:01:38+00:00Codeine linctus (codeine oral solutions): reclassification to prescription-only medicineAdvice for healthcare professionals on the reclassification of codeine linctus to a prescription-only medicine (POM), following a public consultation. 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/codeine-linctus-public-consultation-on-the-proposal-to-reclassify-to-a-prescription-only-medicine2023-07-24T13:59:27+01:00Codeine linctus: public consultation on the proposal to reclassify to a prescription-only medicine We have launched a public consultation on the proposal to reclassify codeine linctus to a prescription-only medicine. 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/letters-and-medicine-recalls-sent-to-healthcare-professionals-in-april-20232023-05-25T10:53:17+01:00Letters and medicine recalls sent to healthcare professionals in April 2023 Recent MHRA National Patient Safety Alerts to remove from service Philips Health Systems V60 and V60 Plus ventilators and to recall Emerade adrenaline auto-injectors from patients, pharmacies and wholesalers. We also provide鈥�tag:www.gov.uk,2005:/drug-safety-update/letters-and-medicine-recalls-sent-to-healthcare-professionals-in-november-20222022-12-12T12:00:19+00:00Letters and medicine recalls sent to healthcare professionals in November 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-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/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/pregabalin-lyrica-findings-of-safety-study-on-risks-during-pregnancy2022-04-19T14:27:52+01:00Pregabalin (Lyrica): findings of safety study on risks during pregnancyA new study has suggested pregabalin may slightly increase the risk of major congenital malformations if used in pregnancy. Patients should continue to use effective contraception during treatment and avoid use in pregnancy 鈥�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/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-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/pregabalin-lyrica-reports-of-severe-respiratory-depression2021-02-18T11:36:41+00:00Pregabalin (Lyrica): reports of severe respiratory depressionPregabalin has been associated with infrequent reports of severe respiratory depression, including some cases without the presence of concomitant opioid medicines. Patients with compromised respiratory function, respiratory 鈥�tag:www.gov.uk,2005:/drug-safety-update/letters-and-drug-alerts-sent-to-healthcare-professionals-in-january-20212021-02-18T11:34:55+00:00Letters and drug alerts sent to healthcare professionals in January 2021A summary of letters and drug alerts recently sent to healthcare professionals.tag:www.gov.uk,2005:/drug-safety-update/opioids-risk-of-dependence-and-addiction2020-09-23T14:28:34+01:00Opioids: risk of dependence and addictionNew recommendations following a review of the risks of dependence and addiction associated with prolonged use of opioid medicines (opioids) for non-cancer pain. Before prescribing opioids, discuss with the patient the risks 鈥�tag:www.gov.uk,2005:/drug-safety-update/transdermal-fentanyl-patches-for-non-cancer-pain-do-not-use-in-opioid-naive-patients2020-09-23T14:28:19+01:00Transdermal fentanyl patches for non-cancer pain: do not use in opioid-naive patientsFollowing a review of the risks associated with use of opioid medicines for non-cancer pain, the Commission on Human Medicines (CHM) has recommended that fentanyl transdermal patches are contraindicated in opioid-naive patie鈥�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-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/benzodiazepines-and-opioids-reminder-of-risk-of-potentially-fatal-respiratory-depression2020-03-18T14:24:19+00:00 Benzodiazepines and opioids: reminder of risk of potentially fatal respiratory depression Benzodiazepines and opioids can both cause respiratory depression, which can be fatal if not recognised in time. Only prescribe together if there is no alternative and closely monitor patients for signs of respiratory depres鈥�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-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鈥�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 鈥�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鈻� (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鈥�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鈻�), Darzalex鈻�(daratumumab), retinoids鈻�, and febuxostat (Adenuric). A recall alert was issued for medicines that were taken out of the regul鈥�tag:www.gov.uk,2005:/drug-safety-update/valproate-medicines-and-serious-harms-in-pregnancy-new-annual-risk-acknowledgement-form-and-clinical-guidance-from-professional-bodies-to-support-compliance-with-the-pregnancy-prevention-programme2019-04-16T15:54:11+01:00Valproate medicines and serious harms in pregnancy: new Annual Risk Acknowledgement Form and clinical guidance from professional bodies to support compliance with the Pregnancy Prevention ProgrammeOngoing patient survey data suggest that more effort is needed by clinicians to achieve full and timely compliance with the valproate Pregnancy Prevention Programme and meet the goal to rapidly reduce and eventually eliminat鈥�tag:www.gov.uk,2005:/drug-safety-update/pregabalin-lyrica-gabapentin-neurontin-and-risk-of-abuse-and-dependence-new-scheduling-requirements-from-1-april2019-04-16T15:53:42+01:00Pregabalin (Lyrica), gabapentin (Neurontin) and risk of abuse and dependence: new scheduling requirements from 1 April As of 1 April 2019, pregabalin and gabapentin are controlled under the Misuse of Drugs Act 1971 as Class C substances and scheduled under the Misuse of Drugs Regulations 2001 as Schedule 3. Evaluate patients carefully for a 鈥�tag:www.gov.uk,2005:/drug-safety-update/letters-and-drug-alerts-sent-to-healthcare-professionals-in-february-20192019-03-21T11:49:28+00:00Letters and drug alerts sent to healthcare professionals in February 2019Letters were sent about Vyxeos (cytarabine, daunorubicin) and Ozurdex 700 micrograms intravitreal implant (dexamethasone). Alerts were issued about irbesartan, amoxicillin, atropine sulfate, and paracetamol infusion.tag:www.gov.uk,2005:/drug-safety-update/tapentadol-palexia-risk-of-seizures-and-reports-of-serotonin-syndrome-when-co-administered-with-other-medicines2019-01-09T16:31:00+00:00 Tapentadol (Palexia): risk of seizures and reports of serotonin syndrome when co-administered with other medicines Tapentadol may increase seizure risk in patients taking other medicines that lower seizure threshold, for example, antidepressants and antipsychotics. Serotonin syndrome has also been reported when tapentadol is used in comb鈥�tag:www.gov.uk,2005:/drug-safety-update/valproate-medicines-are-you-in-acting-in-compliance-with-the-pregnancy-prevention-measures2018-12-18T12:44:49+00:00Valproate medicines: are you acting in compliance with the pregnancy prevention measures?Although use of valproate medicines in female patients continues to slowly decline, there is wide variation in prescribing between Clinical Commissioning Groups (CCGs). Women continue to report instances when they have not r鈥�tag:www.gov.uk,2005:/drug-safety-update/transdermal-fentanyl-patches-life-threatening-and-fatal-opioid-toxicity-from-accidental-exposure-particularly-in-children2018-10-11T11:28:25+01:00Transdermal fentanyl patches: life-threatening and fatal opioid toxicity from accidental exposure, particularly in childrenProvide clear information to patients and caregivers about how to minimise the risk of accidental exposure and the importance of appropriate disposal of patches. We continue to receive reports of unintentional opioid toxicit鈥�tag:www.gov.uk,2005:/drug-safety-update/medical-device-alerts-issued-in-september-20182018-10-11T11:27:17+01:00Medical Device Alerts issued in September 2018Alerts were recently issued by MHRA about flex connectors in Halyard closed suction kits; SureSigns VS & VM patient monitors and viewing stations; and Zimmer Biomet trauma guide wires.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鈻� (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 鈥�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鈻�), and nusinersen (Spinraza鈻�). MHRA issued alerts and recalls for valsartan-containing medicines, Fiasp FlexTouch pre-filled pens, melatonin capsules, and 鈥�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鈥�tag:www.gov.uk,2005:/drug-safety-update/denosumab-xgeva-for-giant-cell-tumour-of-bone-risk-of-clinically-significant-hypercalcaemia-following-discontinuation2018-06-22T12:48:25+01:00Denosumab (Xgeva鈻�) for giant cell tumour of bone: risk of clinically significant hypercalcaemia following discontinuation Monitor patients for signs and symptoms of hypercalcaemia after discontinuation of denosumab treatment for giant cell tumour of bone. Cases of rebound hypercalcemia have been reported up to 9 months after cessation of treatm鈥�tag:www.gov.uk,2005:/drug-safety-update/denosumab-xgeva-for-advanced-malignancies-involving-bone-study-data-show-new-primary-malignancies-reported-more-frequently-compared-to-zoledronate2018-06-22T12:48:14+01:00Denosumab (Xgeva鈻�) for advanced malignancies involving bone: study data show new primary malignancies reported more frequently compared to zoledronateA pooled analysis has shown an increased rate of new primary malignancies in patients given Xgeva (1-year cumulative incidence 1.1%) compared with those given zoledronic acid (0.6%), when used in the indication of the preven鈥�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/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鈥�tag:www.gov.uk,2005:/drug-safety-update/quinine-reminder-of-dose-dependent-qt-prolonging-effects-updated-medicine-interactions2017-11-24T11:09:22+00:00Quinine: reminder of dose-dependent QT-prolonging effects; updated medicine interactionsQuinine has dose-dependent QT-interval-prolonging effects and should be used with caution in patients with risk factors for QT prolongation or in those with atrioventricular block.
tag:www.gov.uk,2005:/drug-safety-update/gabapentin-neurontin-risk-of-severe-respiratory-depression2017-10-26T09:22:25+01:00Gabapentin (Neurontin): risk of severe respiratory depressionGabapentin has been associated with a rare risk of severe respiratory depression even without concomitant opioid medicines. Patients with compromised respiratory function, respiratory or neurological disease, renal impairmen鈥�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.