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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…
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A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices.
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A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices.
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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…
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We 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 …
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A 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…
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Photosensitivity 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.
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The 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…
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We 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…
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A summary of recent letters and notifications sent to healthcare professionals about medicines.
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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…
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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…
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Rarely, 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…
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We 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…
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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.
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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…
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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…
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A summary of letters and drug alerts recently sent to healthcare professionals.
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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…
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Letters were sent about methotrexate, modafinil, Ecalta, Picato, Nexplanon, valproate medicines, e-cigarettes, and Lemtrada. Alerts were issued about finasteride, codeine/paracetamol, and Picato.
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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.
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Letters 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.
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An 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.
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Letters 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…
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Letters 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…
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New 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…
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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…
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Clinical 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…
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Letters 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…
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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…
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Letters were sent about Vyxeos (cytarabine, daunorubicin) and Ozurdex 700 micrograms intravitreal implant (dexamethasone). Alerts were issued about irbesartan, amoxicillin, atropine sulfate, and paracetamol infusion.
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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…
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Letters were sent to healthcare professionals about Lartruvo▼ (olaratumab), quadrivalent influenza vaccine (split virion, inactivated), SGLT2 inhibitors, and carbimazole and thiamazole (synonym: methimazole)-containing produ…
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Alerts were issued about FreeStyle Libre flash glucose sensors and Arjo Minstrel passive floor lifts (portable hoist).
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Warnings 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 …
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Advise 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…
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Letters were sent to healthcare professionals about Jext adrenaline autoinjectors, rivaroxaban, Ozurdex 700 micrograms intravitreal implant, sildenafil, hydrochlorothiazide, and Epilim Chronosphere (sodium valproate). We als…
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Letters 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 …
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Report 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…
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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…
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Solu-Medrone 40 mg may contain trace amounts of milk proteins. Do not use in patients with a known or suspected allergy to cows’ milk.
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Cases of sexual dysfunction, predominantly involving erectile dysfunction and decreased libido, have been reported rarely in patients taking oral isotretinoin for severe acne.
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Systemic 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.
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We 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).
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There 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 …
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A summary of recent letters sent to relevant healthcare professionals, to inform them of updated safety information.
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Some patients may have exacerbation or rebound symptoms of rosacea. It is important to initiate treatment with a small amount of gel and increase the dose gradually, based on tolerability and treatment response.
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Cases of progressive multifocal leukoencephalopathy have been reported in patients taking dimethyl fumarate for multiple sclerosis, who all had prolonged lymphopenia.
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The immunomodulatory effects of fingolimod increase the risk of progressive multifocal leukoencephalopathy and opportunistic infections.
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In March 2016, letters were sent regarding SGLT2 inhibitors, insulin lispro, natalizumab, noradrenaline, radium-223 dichloride, aflibercept and idelalisib.