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Letters were sent in September about Dacogen (decitabine), Eperzan▼(albiglutide), ERWINASE, ReoPro (abciximab), and recombinant human erythropoietins.
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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.…
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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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New guidance on contraceptive methods and frequency of pregnancy testing to reduce inadvertent exposures during pregnancy in a woman taking a medicine of teratogenic potential.
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Healthcare professionals should not prescribe them to newly diagnosed patients as first-line treatment, except for those with severe hypertriglyceridaemia or those who cannot take statins.
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European Medicines Agency has recommends the use of modafinil should be restricted to treat only sleepiness associated with narcolepsy - should no longer be used for obstructive sleep apnoea or chronic shift work sleep disor…
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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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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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Do not prescribe etoricoxib to patients whose blood pressure is persistently above 140/90 mmHg and inadequately controlled.
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Patients should be transferred to alternative bronchodilator therapy.
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Risks of Nicobrevin outweigh any benefits.
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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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In light of feedback, we have clarified our article on concomitant use of these medicines in heart failure.
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A summary of recent letters and notifications sent to healthcare professionals about medicines.
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The paediatric indication for chloral hydrate (for children aged 2 years and older) and cloral (previously chloral) betaine (children aged 12 years and older) has been restricted to short-term treatment (maximum 2 weeks) of …
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Possible illicit drug use should be considered when prescribing medicines that have the potential to interact adversely.
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Patients who use products that contain maltose, xylose, or galactose should use glucose-specific monitors.
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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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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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Where possible, use an appropriate alternative therapy for patients at increased risk of thrombosis.
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Rare occurrence of serious allergic reactions should not preclude use of parenteral thiamine in patients who need treatment by this route of administration.
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Patients with epilepsy should not take products that contain St John’s wort as any antiepileptic medicine may interact with St John’s wort.
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As the safety of COVID-19 antivirals in pregnancy has not been established, please report any pregnancies which occur during use of an antiviral, including paternal use, to the UK COVID-19 Antivirals Pregnancy Registry. This…
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Benefits of these medicines used in conjunction with inhaled corticosteroids (ICS) in the control of asthma symptoms in children outweigh any apparent risks.
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Restricted dose and duration of use.
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Update on managing risk of misuse.
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A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices and details of two recent MHRA National Patient Safety Alerts to remove from service Philips Health Systems V…
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Following a review by the Commission on Human Medicines (CHM), the marketing authorisation (licence) for levothyroxine 100 microgram tablets manufactured by Teva has been suspended.
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Evidence indicates risks outweigh benefits.
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Do not prescribe ergots to patients who have had fibrosis in the heart, lungs, or abdomen.
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Patients who require a liquid oral formulation of a β-agonist should be switched to a more-selective short-acting β2-agonist such as salbutamol or terbutaline.
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Surgeons reminded to have competent personnel and emergency facilities available for at least 1 hour after administration of the blue dye.
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A summary of letters and drug alerts recently sent to healthcare professionals.
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There is a small increase in the risk of Guillain-Barré syndrome following vaccination with Abrysvo (Pfizer respiratory syncytial virus (RSV) vaccine) and Arexvy (GSK RSV vaccine) in adults aged 60 years and older. Healthca…
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Should not be used for cough under 18 years
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Sales restrictions introduced in 2008 continue to be successful in managing the risk of misuse of pseudoephedrine and ephedrine.
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Recent information relating to COVID-19 vaccines and medicines that has been published since the February 2023 issue of Drug Safety Update, up to 21 March 2023.
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The authorised dose regimen for N-acetylcysteine (NAC) in paracetamol overdose is 3 consecutive bags given intravenously over 21 hours. Prescribing information is being updated to advise that continued treatment with NAC may…
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Unless there are exceptional circumstances, valproate-containing medicines must always be dispensed in the manufacturer’s original full pack.
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Rare cases of atypical femoral fracture with long-term use.
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The non-identical nature of biological medicines and vaccines means it is very important that safety surveillance is carried out on a brand/product-specific basis.
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Implementation of measures to regulate sales, together with the additional voluntary actions overseen by the pharmacy profession, has made an important contribution to managing the risk of misuse of pseudoephedrine and ephed…
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Do not use codeine in children under 12 as it is associated with a risk of respiratory side effects. Codeine is not recommended for adolescents (12 to 18) who have problems with breathing.
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Review 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 valproate.…
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Patients with existing meningioma or a history of meningioma must not be prescribed high-dose (≥25 mg per day) cyproterone acetate.
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Guidance has been published on monitoring of patients on warfarin and other anticoagulants during the COVID-19 pandemic.
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A clinically significant interaction between carbapenems and valproic acid results in reduced valproate plasma concentrations with potential for inadequate seizure control. Concomitant use of these agents is not recommended,…
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Evidence does not support any increased risk of cancer in patients who use these medicines.
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Calcitonin-containing medicines should no longer be used in treatment of osteoporosis.