tag:www.gov.uk,2005:/drug-safety-updateDrug Safety Update about Dermatology2025-05-15T11:30:20+01:00HM Governmenttag:www.gov.uk,2005:/drug-safety-update/thiopurines-and-intrahepatic-cholestasis-of-pregnancy2025-05-15T11:30:20+01:00Thiopurines and intrahepatic cholestasis of pregnancy Intrahepatic cholestasis of pregnancy (ICP) has been rarely reported in patients treated with azathioprine products and is believed to be a risk applicable to all drugs in the thiopurine class (azathioprine, mercaptopurine a�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/epimax-ointment-and-epimax-paraffin-free-ointment-reports-of-ocular-surface-toxicity-and-ocular-chemical-injury2024-07-23T14:01:13+01:00Epimax Ointment and Epimax Paraffin-Free Ointment: reports of ocular surface toxicity and ocular chemical injuryEpimax Ointment and Epimax Paraffin-Free Ointment can harm the eyes if used on the face. Do not prescribe these ointments for use on the face. Tell patients to wash their hands and avoid touching their eyes after using these�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/topical-steroids-introduction-of-new-labelling-and-a-reminder-of-the-possibility-of-severe-side-effects-including-topical-steroid-withdrawal-reactions2024-05-29T14:32:45+01:00Topical steroids: introduction of new labelling and a reminder of the possibility of severe side effects, including Topical Steroid Withdrawal Reactions Topical steroid products are safe and highly effective treatments for the management of a wide range of inflammatory skin diseases but have important risks, especially with prolonged use at high potency. In the coming months�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-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/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/vitamin-b12-hydroxocobalamin-cyanocobalamin-advise-patients-with-known-cobalt-allergy-to-be-vigilant-for-sensitivity-reactions2023-12-18T14:51:12+00:00Vitamin B12 (hydroxocobalamin, cyanocobalamin): advise patients with known cobalt allergy to be vigilant for sensitivity reactions The medicines used to treat vitamin B12 deficiency (hydroxocobalamin, cyanocobalamin) contain cobalt. There are case reports in the literature describing cobalt sensitivity-type reactions in patients being treated for vitami�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/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/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/isotretinoin-roaccutanev-new-safety-measures-to-be-introduced-in-the-coming-months-including-additional-oversight-on-initiation-of-treatment-for-patients-under-18-years2023-04-26T11:39:46+01:00Isotretinoin (Roaccutane�): new safety measures to be introduced in the coming months, including additional oversight on initiation of treatment for patients under 18 yearsThe Isotretinoin Expert Working Group of the Commission on Human Medicines has made recommendations to strengthen the safety of isotretinoin treatment. Recommendations include new warnings, the need for consistent monitoring�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-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/dupilumab-dupixentv-risk-of-ocular-adverse-reactions-and-need-for-prompt-management2022-11-29T14:00:26+00:00Dupilumab (Dupixent�): risk of ocular adverse reactions and need for prompt management Healthcare professionals prescribing dupilumab should be alert to the risks of ocular reactions. New onset or worsening ocular symptoms require prompt review. Referral for ophthalmological examination should be made as appro�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/topical-corticosteroids-information-on-the-risk-of-topical-steroid-withdrawal-reactions2021-09-15T10:38:00+01:00Topical corticosteroids: information on the risk of topical steroid withdrawal reactionsRarely, severe adverse effects can occur on stopping treatment with topical corticosteroids, often after long-term continuous or inappropriate use of moderate to high potency products. To reduce the risks of these events, pr�tag:www.gov.uk,2005:/drug-safety-update/oral-retinoid-medicines-isotretinoinv-alitretinoinv-and-acitretinv-temporary-monitoring-advice-during-coronavirus-covid-19-pandemic2021-07-07T17:13:31+01:00Oral retinoid medicines (isotretinoin�, alitretinoin�, and acitretin�): temporary monitoring advice during coronavirus (COVID-19) pandemicWe have published guidance about the use of remote consultations for pregnancy prevention in women of childbearing potential and monitoring for signs of psychiatric reactions (especially depression) and other safety risks in�tag:www.gov.uk,2005:/drug-safety-update/emollients-and-risk-of-severe-and-fatal-burns-new-resources-available2021-05-20T12:04:42+01:00Emollients and risk of severe and fatal burns: new resources available We inform healthcare professionals of the recent campaign to promote awareness of the risk and new resources available to support safe use following previous advice to health and care professionals.
tag:www.gov.uk,2005:/drug-safety-update/isotretinoin-roaccutane-contribute-to-expert-review2020-11-16T15:58:49+00:00Isotretinoin (Roaccutane�): contribute to expert review A review is being undertaken by the Medicines and Healthcare products Regulatory Agency with advice from the Commission on Human Medicines and the Isotretinoin Expert Working Group due to concerns about the possible associat�tag:www.gov.uk,2005:/drug-safety-update/isotretinoin-roaccutane-reminder-of-important-risks-and-precautions2020-08-26T14:08:14+01:00Isotretinoin (Roaccutane�): reminder of important risks and precautions We remind healthcare professionals that isotretinoin should only be used for severe forms of acne resistant to adequate courses of standard therapy with systemic antibacterials and topical therapy. Prescription of isotretino�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/ingenol-mebutate-gel-picato-suspension-of-the-licence-due-to-risk-of-skin-malignancy2020-02-12T16:44:22+00:00Ingenol mebutate gel (Picato�): suspension of the licence due to risk of skin malignancy Stop prescribing Picato and consider other treatment options for actinic keratosis as appropriate. The licence of ingenol mebutate (Picato) has been suspended as a precautionary measure while the European Medicines Agency (E�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/ingenol-mebutate-gel-picato-increased-incidence-of-skin-tumours-seen-in-some-clinical-studies2019-10-18T15:40:50+01:00Ingenol mebutate gel (Picatoâ–�): increased incidence of skin tumours seen in some clinical studies Advise patients treated with ingenol mebutate gel to be vigilant for new skin lesions and to seek medical advice immediately should any occur. Use with caution in patients with a history of skin cancer.
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/medical-devices-alerts-issued-in-august-20192019-09-19T11:39:47+01:00 Medical Devices Alerts issued in August 2019An alert was issued advising against use of Dermapen 3 and Dermapen Cryo Sterile single use needle cartridge tips for Dermapen 3 since their safety cannot be verified.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/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/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/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/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/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/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/medical-device-alerts-issued-in-january-20192019-02-20T08:51:04+00:00Medical Device Alerts issued in January 2019Alerts were issued about FreeStyle Libre flash glucose sensors and Arjo Minstrel passive floor lifts (portable hoist).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/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/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-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/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/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�tag:www.gov.uk,2005:/drug-safety-update/methylprednisolone-injectable-medicine-containing-lactose-solu-medrone-40-mg-do-not-use-in-patients-with-cows-milk-allergy2017-10-26T09:22:34+01:00Methylprednisolone injectable medicine containing lactose (Solu-Medrone 40 mg): do not use in patients with cows� milk allergySolu-Medrone 40 mg may contain trace amounts of milk proteins. Do not use in patients with a known or suspected allergy to cows� milk.tag:www.gov.uk,2005:/drug-safety-update/isotretinoin-roaccutane-rare-reports-of-erectile-dysfunction-and-decreased-libido2017-10-26T09:22:15+01:00Isotretinoin (Roaccutane): rare reports of erectile dysfunction and decreased libido Cases of sexual dysfunction, predominantly involving erectile dysfunction and decreased libido, have been reported rarely in patients taking oral isotretinoin for severe acne.tag:www.gov.uk,2005:/drug-safety-update/brimonidine-gel-mirvaso-risk-of-systemic-cardiovascular-effects-not-to-be-applied-to-damaged-skin2017-06-21T09:54:22+01:00Brimonidine gel (Mirvaso): risk of systemic cardiovascular effects; not to be applied to damaged skinSystemic cardiovascular effects including bradycardia, hypotension, and dizziness have been reported after application. It is important to avoid application to irritated or damaged skin, including after laser therapy.tag:www.gov.uk,2005:/drug-safety-update/finasteride-rare-reports-of-depression-and-suicidal-thoughts2017-05-24T15:30:19+01:00Finasteride: rare reports of depression and suicidal thoughtsWe have received reports of depression and, in rare cases, suicidal thoughts in men taking finasteride 1 mg (Propecia) for male pattern hair loss. Be aware that depression is also associated with finasteride 5 mg (Proscar).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 �