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The maximum recommended dose for simvastatin in conjunction with amlodipine and diltiazem is now 20 mg/day.
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Different antiepileptic drugs (AEDs) vary considerably in their characteristics, which influences the risk of whether switching between different manufacturers’ products of a particular drug may cause adverse effects or loss…
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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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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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A summary of letters sent to relevant healthcare professionals in January 2017.
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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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The MHRA has reviewed the evidence for finasteride and dutasteride and the risk of suicidal thoughts and behaviours and has recommended further measures to minimise this risk.
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Letters were sent about Arsenic Trioxide (Trisenox), Uptravi▼ (selexipag), DepoCyte (cytarabine), Cinryze▼ (C1 esterase inhibitor [human]), and Clexane (enoxaparin sodium).
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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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Fezolinetant treatment is associated with a risk of drug induced liver injury. New recommendations have been introduced to minimise this risk. Liver function should be monitored before and during treatment in all patients ta…
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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 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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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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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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Do not prescribe etoricoxib to patients whose blood pressure is persistently above 140/90 mmHg and inadequately controlled.
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Risks of Nicobrevin outweigh any benefits.
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Patients should be transferred to alternative bronchodilator therapy.
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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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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.
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If bilirubin and/or creatinine test results are inconsistent with clinical observations, request re-testing using another method to determine the validity of the result.
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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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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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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 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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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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While an urgent EU-wide review of new information on liver safety is under way, promptly review patients on treatment. Only initiate daclizumab in restricted groups of patients with limited treatment options and keep all pat…
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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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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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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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Update on managing risk of misuse.
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Restricted dose and duration of use.
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Liver monitoring requirements and discontinuation criteria for fingolimod have been updated following reports of serious liver injury. Fatal cases of encephalitis and meningitis caused by herpes simplex and varicella zoster …
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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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Toxic effects can occur with nitrous oxide especially with prolonged use.
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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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Unless there are exceptional circumstances, valproate-containing medicines must always be dispensed in the manufacturer’s original full pack.
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Should not be used for cough under 18 years
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Reminder to test liver function before and during treatment.
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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.