tag:www.gov.uk,2005:/drug-safety-updateDrug Safety Update about Psychiatry2025-02-13T15:02:39+00:00HM Governmenttag:www.gov.uk,2005:/drug-safety-update/valproate-belvo-convulex-depakote-dyzantil-epilim-epilim-chrono-or-chronosphere-episenta-epival-and-syonellv-review-by-two-specialists-is-required-for-initiating-valproate-but-not-for-male-patients-already-taking-valproate2025-02-13T15:02:39+00:00Valproate (Belvo, Convulex, Depakote, Dyzantil, Epilim, Epilim Chrono or Chronosphere, Episenta, Epival, and Syonell▼): review by two specialists is required for initiating valproate but not for male patients already taking valproateReview by two specialists remains in place for patients initiating valproate under 55 years of age but the Commission on Human Medicines (CHM) has advised that it will not be required for men (or males) currently taking valp…tag: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/valproate-use-in-men-as-a-precaution-men-and-their-partners-should-use-effective-contraception2024-09-05T14:31:10+01:00Valproate use in men: as a precaution, men and their partners should use effective contraceptionA retrospective observational study has indicated a possible association between valproate use by men around the time of conception and an increased risk of neurodevelopmental disorders in their children.
Inform male p…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/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-february-20242024-03-27T11:53:02+00:00Letters and medicine recalls sent to healthcare professionals in February 2024A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices.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-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/valproate-belvo-convulex-depakote-dyzantil-epilim-epilim-chrono-or-chronosphere-episenta-epival-and-syonellv-new-safety-and-educational-materials-to-support-regulatory-measures-in-men-and-women-under-55-years-of-age2024-01-22T15:41:20+00:00Valproate (Belvo, Convulex, Depakote, Dyzantil, Epilim, Epilim Chrono or Chronosphere, Episenta, Epival, and Syonell▼): new safety and educational materials to support regulatory measures in men and women under 55 years of ageNew safety and educational materials have been introduced for men and women and healthcare professionals to reduce the harms from valproate, including the significant risk of serious harm to the baby if taken during pregnanc…tag:www.gov.uk,2005:/drug-safety-update/aripiprazole-abilify-and-generic-brands-risk-of-pathological-gambling2023-12-18T14:51:18+00:00Aripiprazole (Abilify and generic brands): risk of pathological gambling Healthcare professionals prescribing aripiprazole are reminded to be alert to the risk of addictive gambling and other impulse control disorders. Healthcare professionals should advise patients, their families and friends to…tag:www.gov.uk,2005:/drug-safety-update/letters-and-medicine-recalls-sent-to-healthcare-professionals-in-october-20232023-11-23T14:15:26+00:00 Letters and medicine recalls sent to healthcare professionals in October 2023A summary of recent letters and notifications sent to healthcare professionals about medicines.tag:www.gov.uk,2005:/drug-safety-update/isotretinoin-roaccutanev-introduction-of-new-safety-measures-including-additional-oversight-of-the-initiation-of-treatment-for-patients-under-18-years-of-age2023-10-31T10:29:28+00:00Isotretinoin (Roaccutane▼): introduction of new safety measures, including additional oversight of the initiation of treatment for patients under 18 years of ageWe have strengthened the safe use of isotretinoin through the introduction of additional oversight of the initiation of isotretinoin in patients under 18 years and through improved assessment and monitoring of mental health …tag:www.gov.uk,2005:/drug-safety-update/valproate-dispense-full-packs-of-valproate-containing-medicines2023-10-31T10:29:15+00:00Valproate: dispense full packs of valproate-containing medicinesUnless there are exceptional circumstances, valproate-containing medicines must always be dispensed in the manufacturer’s original full pack. tag:www.gov.uk,2005:/drug-safety-update/valproate-re-analysis-of-study-on-risks-in-children-of-men-taking-valproate2023-08-30T10:31:12+01:00Valproate: re-analysis of study on risks in children of men taking valproate We are providing an update on a retrospective observational study on the risk to children born to men who took valproate in the 3 months before conception and on the need for the re-analysis of the data from this study befor…tag:www.gov.uk,2005:/drug-safety-update/valproate-reminder-of-current-pregnancy-prevention-programme-requirements-information-on-new-safety-measures-to-be-introduced-in-the-coming-months2022-12-12T12:00:31+00:00Valproate: reminder of current Pregnancy Prevention Programme requirements; information on new safety measures to be introduced in the coming monthsIn view of data showing ongoing exposure to valproate in pregnancy, this article reminds healthcare professionals of the risks in pregnancy and the current Pregnancy Prevention Programme requirements, and provides informatio…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/methylphenidate-long-acting-modified-release-preparations-caution-if-switching-between-products-due-to-differences-in-formulations2022-09-26T16:19:41+01:00Methylphenidate long-acting (modified-release) preparations: caution if switching between products due to differences in formulationsPrescribers and dispensers should use caution if switching patients between different long-acting formulations of methylphenidate (Concerta XL, Medikinet XL, Equasym XL, Ritalin LA, and generics) as different instructions fo…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-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/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/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 …tag:www.gov.uk,2005:/drug-safety-update/letters-and-medicine-recalls-sent-to-healthcare-professionals-in-march-20222022-04-19T14:27:17+01:00Letters and medicine recalls sent to healthcare professionals in March 2022A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices. Includes a recent recall of Accuretic (quinapril hydrochloride and hydrochlorothiazide).tag:www.gov.uk,2005:/drug-safety-update/haloperidol-haldol-reminder-of-risks-when-used-in-elderly-patients-for-the-acute-treatment-of-delirium2021-12-10T11:01:51+00:00Haloperidol (Haldol): reminder of risks when used in elderly patients for the acute treatment of delirium We remind healthcare professionals that elderly patients are at an increased risk of adverse neurological and cardiac effects when being treated with haloperidol for delirium. The lowest possible dose of haloperidol should b…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-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/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 …tag:www.gov.uk,2005:/drug-safety-update/ssri-slash-snri-antidepressant-medicines-small-increased-risk-of-postpartum-haemorrhage-when-used-in-the-month-before-delivery2021-01-07T11:00:29+00:00SSRI/SNRI antidepressant medicines: small increased risk of postpartum haemorrhage when used in the month before deliverySSRIs and SNRIs are known to increase bleeding risks due to their effect on platelet function. Data from observational studies suggest that the use of SSRI/SNRI antidepressants during the month before delivery may result in …tag:www.gov.uk,2005:/drug-safety-update/letters-and-drug-alerts-sent-to-healthcare-professionals-in-september-20202020-10-22T14:14:36+01:00Letters and drug alerts sent to healthcare professionals in September 2020A summary of letters and drug alerts recently sent to healthcare professionals.tag:www.gov.uk,2005:/drug-safety-update/clozapine-and-other-antipsychotics-monitoring-blood-concentrations-for-toxicity2020-08-26T14:09:15+01:00Clozapine and other antipsychotics: monitoring blood concentrations for toxicityMonitoring blood concentrations of clozapine (Clozaril, Denzapine, Zaponex) for toxicity is now advised in certain clinical situations. Blood level monitoring of other antipsychotics for toxicity may also be helpful in certa…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/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…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/valproate-epilim-depakote-pregnancy-prevention-programme-updated-educational-materials2020-02-12T16:43:54+00:00Valproate (Epilim▼, Depakote▼) pregnancy prevention programme: updated educational materialsIn January 2020, healthcare professionals received updated educational materials to support the valproate pregnancy prevention programme. Valproate is contraindicated in girls and women of childbearing potential, unless the …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-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-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/montelukast-singulair-reminder-of-the-risk-of-neuropsychiatric-reactions2019-09-19T11:40:35+01:00Montelukast (Singulair): reminder of the risk of neuropsychiatric reactionsPrescribers should be alert for neuropsychiatric reactions in patients taking montelukast and carefully consider the benefits and risks of continuing treatment if they occur.
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/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/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/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…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/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 …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/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…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…