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Patients who present with acute or worsening signs and symptoms of keratitis should be referred promptly to an ophthalmology specialist.
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The European Medicines Agency has advised that no change in recommendations for use is required at present.
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New safety information for intensive monitoring of Erlotinib.
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There have been reports of rejection of solid organ transplants in patients treated with nivolumab or pembrolizumab. Ipilimumab (Yervoy▼) may also interfere with immunosuppressive therapy, increasing the risk of graft reject…
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Establish hepatitis B virus status before initiating daratumumab and in patients with unknown hepatitis B virus serology who are already being treated with daratumumab.
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Recent clinical trials have shown increased mortality when bendamustine (Levact) was used in combination treatments outside its approved indications. Be aware that the risk of opportunistic infections for all patients receiv…
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Use trametinib, authorised either as monotherapy or combined with dabrafenib, with caution in patients with risk factors for gastrointestinal perforation.
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Periodically perform skin examinations in patients on bendamustine-containing regimens and consider PML in the differential diagnosis for patients on bendamustine with new or worsening neurological, cognitive, or behavioural…
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The third-line treatment indication for rucaparib has been withdrawn following a review of the findings of the ARIEL-4 trial, which showed lower overall survival for rucaparib treatment versus standard chemotherapy in patients with high-grade epithelial ovarian, fallopian tube or primary…
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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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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 necrolysis (TEN).…
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There have been reports of necrotising and haemorrhagic pancreatitis in people taking exenatide some of which were fatal - stop exenatide treatment if pancreatitis is diagnosed.
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Updated guidance on minimising risk of life-threatening and fatal air embolism.
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Denosumab is associated with a risk of osteonecrosis of the jaw, osteonecrosis of the external auditory canal has also been reported with denosumab.
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Recent information relating to COVID-19 vaccines and medicines that has been published since the November 2021 issue of Drug Safety Update, up to 3 December 2021.
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A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices.
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Mycophenolate 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…
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Increase the frequency of blood pressure monitoring to at least weekly for the first 2 months, and then monitor monthly for the first year and periodically thereafter during treatment, following recent reports of onset of se…
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Healthcare professionals should consider a dose reduction or discontinuation of mycophenolate mofetil if patients develop pure red cell aplasia.…
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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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Monitor patients closely for skin cancers. Advise patients to seek urgent attention if they develop signs or symptoms of serious infections.
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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 treatment.
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Test liver function before and during treatment and tell patients to avoid sunlight exposure.
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Dental examination and appropriate preventive dentistry should be considered before treatment with bevacizumab or sunitinib.
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Alanine 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 …
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Possible increased risk of retinopathy with epoetin beta in premature infants calls for careful consideration of options for preventing anaemia of prematurity.
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The immunomodulatory effects of fingolimod increase the risk of progressive multifocal leukoencephalopathy and opportunistic infections.
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Capillary leak syndrome (CLS) has been reported in recipients of filgrastim, including patients undergoing chemotherapy and a healthy donor undergoing peripheral blood progenitor-cell mobilisation; it has also been reported in recipients of pegfilgrastim undergoing chemotherapy.…
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Consider progressive multifocal encephalopathy (PML) in the differential diagnosis for patients with new or worsening neurological signs or symptoms, even several years after treatment with cladribine.
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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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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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Evaluate 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…
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Healthcare professionals should consider the possibility of second primary malignancy in patients treated with lenalidomide.
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Topical oral salicylate gels are no longer indicated for people younger than 16 years for pain associated with infant teething, orthodontic devices, cold sores, or mouth ulcers.
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Serious 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…
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With the exception of medicines containing zidovudine, stavudine, or didanosine, product information will no longer include warnings on fat redistribution or lactic acidosis.
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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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Severe infusion-related hypersensitivity reactions have occurred in patients receiving temsirolimus.
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Fatal cases of tumour lysis syndrome (TLS) have been reported, some occurring in patients with chronic lymphocytic leukaemia receiving the lowest venetoclax dose used in the dose-titration schedule. For all patients, it is i…
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There have been reports of thrombotic microangiopathy and nephrotic syndrome linked to interferon beta treatment.
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Routine monitoring of liver function now recommended.
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Over-correction of haemoglobin concentration may increase the risk of death and serious cardiovascular events in patients with chronic kidney disease; it may increase the risk of thrombosis and related complications in patie…
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Letters were sent about azithromycin, Lynparza▼(Olaparib), Xgeva▼ (denosumab), Lymphoseek (tilmanocept), ReoPro (abciximab) and dolutegravir; you still have time to complete a quick survey to tell us your views on the way me…
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Temporarily discontinue ibrutinib in patients who develop symptoms suggestive of ventricular arrhythmia and assess benefit-risk before restarting therapy. Establish hepatitis B virus status before initiating ibrutinib. Consi…
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Monitoring for encephalitis should continue for 12 months following discontinuation of daclizumab. Inform all patients who have discontinued daclizumab and their caregivers of the common symptoms of encephalitis and the need…
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A 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…
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Healthcare professionals reminded that tacrolimus may be associated with possible risk of malignancy.
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In patients at risk for aortic aneurysm and dissection, fluoroquinolones should only be used after careful assessment of the benefits and risks and after consideration of other therapeutic options.
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MHRA continues to identify cases of herbal medicines, particularly traditional Chinese medicines, which contain illegal and toxic Aristolochia or aristolochic acids.
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Risk of aseptic peritonitis with Dianeal, Extraneal, and Nutrineal peritoneal dialysis solutions due to possible presence of endotoxin.