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…In the coming months, as a result of regulatory action, topical steroid products will be labelled with information on their potency to simplify advice for patients.
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…To reduce the risks of these events, prescribe the topical corticosteroid of lowest potency needed and ensure patients know how to use it safely and effectively.…
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…Recently, it has also been reported after local administration of corticosteroids via inhaled and intranasal, epidural, intra-articular, topical dermal, and periocular routes.…
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Epimax 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…
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Oral diclofenac is associated with a small increased risk of cardiovascular side effects and is therefore no longer available over the counter.
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Patients should be reminded and reassured that there is no evidence that taking paracetamol during pregnancy causes autism in children. Paracetamol is recommended as the first-choice pain reliever for pregnant women, used at…
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Systemic piroxicam should be initiated only by specialists as a second-line treatment for arthritis, with patients who currently take piroxicam reassessed at a routine appointment.
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Confidential reports designed to help you improve the quality of your prescribing and patient safety are now available for practices that contribute to the MHRA’s Clinical Practice Research Datalink.
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New recommendations after a Europe-wide review of cardiovascular safety.
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Proton pump inhibitors (PPIs) are associated with very infrequent cases of subacute cutaneous lupus erythematosus (SCLE), a non-scarring dermatosis that can develop in sun-exposed areas.
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Caution is required if prescribing febuxostat in patients with pre-existing major cardiovascular disease, particularly, in those with evidence of high urate crystal and tophi burden or those initiating urate-lowering therapy…
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We 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).
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Risk of early psychiatric side-effects is one of several important safety issues for healthcare professionals to discuss with patients and carers, who should seek urgent medical advice in the event of any worrying symptoms.
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Risk of psychological and behavioural side effects.
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Physicians should remain vigilant for pneumonia and other infections of the lower respiratory tract (ie, bronchitis) in patients with chronic obstructive pulmonary disease who are treated with inhaled products that contain steroids
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Coadministration of a corticosteroid with an HIV-treatment-boosting agent may increase the risk of adrenal suppression due to a pharmacokinetic interaction.
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Osteonecrosis of the external auditory canal has been reported very rarely (fewer than 1 in 10 000 patients) with bisphosphonates, mainly in association with long-term therapy (2 years or longer).
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Screening for hepatitis B virus is now recommended in all patients (not only those at risk of this infection) before starting treatment for all indications.
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Prescribing information has been updated to introduce a lower recommended dose of 60 mg daily for patients with rheumatoid arthritis or ankylosing spondylitis.
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New safety information for intensive monitoring of Erlotinib.
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Aceclofenac is now contraindicated in patients with certain established cardiovascular diseases.
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Onsenal▼ (celecoxib) is no longer approved in Europe for the reduction of intestinal polyps in familial adenomatous polyposis (FAP).
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Modafinil potentially increases the risk of congenital malformations when used in pregnancy. Modafinil should not be used during pregnancy and women of childbearing potential must use effective contraception during treatment…
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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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You should take caution when you use NSAIDs in patients with renal impairment or are at risk.
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Further evidence that the cardiovascular risk with diclofenac is higher than other non-selective NSAIDs and similar to the selective COX-2 inhibitors.
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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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Use of aliskiren can cause angioedema, a rare and serious side effect, and or acute renal failure.
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Healthcare professionals should consider measuring magnesium levels before starting PPI treatment and repeat measurements periodically during prolonged treatment.
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Patients should use the lowest effective dose, and the shortest duration of treatment necessary to control symptoms.
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MHRA has found samples of intensive body lotion with aloe vera (OSAS) to contain corticosteroid betamethasone.
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Reports of acquired haemophilia have been received in association with clopidogrel.
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Reminder on risk of serious and fatal toxicity in overdose.
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Prescribing advice should be followed carefully, particularly recommended upper dose limits due to associated higher gastrointestinal risk than most other NSAIDs in the class.
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Updated advice on use of nicorandil as second-line treatment for stable angina - some ulcers may progress to complications unless treatment is stopped.
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New monitoring instructions to detect these side effects as soon as possible.
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Use baricitinib with caution in patients with diverticular disease and in those concomitantly treated with medications associated with an increased risk of diverticulitis.
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Risk of serious haemorrhage—clarified contraindications apply to all 3 medicines.
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EU review confirms that the cardiovascular risk of high-dose ibuprofen (≥2400mg/day) is similar to COX 2 inhibitors and diclofenac.
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European Medicines Agency says further measures should be put in place to minimise the risk of adverse skin reactions.
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The risk of developing progressive multifocal leukoencephalopathy (PML) with natalizumab increases after 2 years of therapy. Patients with multiple sclerosis should be informed of the risk before treatment, and again after 2…
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Key MHRA advice and guidance issued so far on medicines safety and pharmacovigilance, including on reporting to the Yellow Card Scheme.
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A reminder for those who use topical ketoprofen to avoid direct sunlight, ultraviolet rays, sunbeds or sunlamps.
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A summary of recent letters, medicine recalls and notifications sent to healthcare professionals.
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Premature puberty and genital enlargement have been reported in children who were in close physical contact with an adult using topical testosterone and who were repeatedly accidentally exposed to this medicine.…
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We have initiated a new safety review into topiramate as a result of an observational study reporting an increased risk of neurodevelopmental disabilities in children whose mothers took topiramate during pregnancy.
Topir…
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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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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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Healthcare professionals reminded that tacrolimus may be associated with possible risk of malignancy.
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Monitor serum phosphate levels in patients treated with multiple high-dose administrations, or those on long-term treatment, and in those with pre-existing risk factors for hypophosphataemia. Re-evaluate ferric carboxymaltos…