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A summary of letters sent to relevant healthcare professionals in January 2017.
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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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Latest evidence suggests long-term use of combined oral contraceptives or progestogen-only injectable contraceptives is associated with a small increased risk of cervical cancer.
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The Commission on Human Medicines has issued a series of recommendations to strengthen measures to minimise risk with the yellow fever vaccine (Stamaril) following very rare fatal reactions.…
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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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Public consultation launched on the continued availability of oral diclofenac as a pharmacy (P) medicine and on risk-minimisation measures advised by the Commission on Human Medicines.
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The European Medicines Agency (EMA) has concluded that oral fluoroquinolone norfloxacin (Utinor) shouldn't be used to treat acute or chronic, complicated pyelonephritis.
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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 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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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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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 says further measures should be put in place to minimise the risk of adverse skin reactions.
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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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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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Patients should be transferred to alternative bronchodilator therapy.
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Risks of Nicobrevin outweigh any benefits.
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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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A summary of recent letters and notifications sent to healthcare professionals about medicines.
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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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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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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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Patients who use products that contain maltose, xylose, or galactose should use glucose-specific monitors.
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Where possible, use an appropriate alternative therapy for patients at increased risk of thrombosis.
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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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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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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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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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Evidence indicates risks outweigh benefits.
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Update on managing risk of misuse.
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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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A summary of letters and drug alerts recently sent to healthcare professionals.
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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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Restricted dose and duration of use.
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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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Do not prescribe ergots to patients who have had fibrosis in the heart, lungs, or abdomen.
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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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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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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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Unless there are exceptional circumstances, valproate-containing medicines must always be dispensed in the manufacturer’s original full pack.
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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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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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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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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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Guidance has been published on monitoring of patients on warfarin and other anticoagulants during the COVID-19 pandemic.
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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 tighter controls being introduced to minimise risk of overuse and or addiction of painkillers containing codeine or dihydrocodeine.
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Calcitonin-containing medicines should no longer be used in treatment of osteoporosis.
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Rare cases of atypical femoral fracture with long-term use.