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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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Rare cases of atypical femoral fracture with long-term use.
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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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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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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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Emerging clinical trial evidence of increased cardiovascular risk.
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Evidence does not support any increased risk of cancer in patients who use these medicines.
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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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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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Calciphylaxis is a very rare but serious condition causing vascular calcification and skin necrosis.
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These medicines are not first-line options for insomnia.
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Calcitonin-containing medicines should no longer be used in treatment of osteoporosis.
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Recent information relating to COVID-19 vaccines and medicines that has been published since the April 2022 issue of Drug Safety Update, up to 13 May 2022.
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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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Continued monitoring of medicines with a black triangle status.
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Mixing drugs together, where one is not a vehicle for the administration of the other, creates an unlicensed medicine.
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Strengthening surveillance of medicines throughout the EU
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All products to be named and prescribed as caffeine citrate.
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Recent information relating to COVID-19 vaccines and medicines that has been published since the January 2022 issue of Drug Safety Update, up to 11 February 2022.
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Aluminium can be leached from glass after contact with calcium gluconate solution, leading to a risk of exposure to aluminium. Accumulation of aluminium might have adverse effects on bone mineralisation and neurological deve…
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New safety and educational materials have been introduced for men and women and healthcare professionals to reduce the harms from valproate, including the significant risk of serious harm to the baby if taken during pregnanc…
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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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Careful monitoring of serum sodium important, co-administration of other drugs that may increase serum sodium not recommended.
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In addition to the 3 risk-based categories of antiepileptic drugs, patient-related factors should be considered when deciding whether it is necessary to maintain continuity of supply for a specific product.
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Spontaneous reporting on the Yellow Card portal has provided important information in the identification of PML associated with some drugs.
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Reporting suspected adverse reactions experienced by the woman or child associated with medicines taken during pregnancy.
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Clinical trials have reported an increased risk of renal dysfunction and mortality in critically ill or septic patients who received hydroxyethyl starch (HES) compared with crystalloids.
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Information on the newly launched Safer Medicines in Pregnancy and Breastfeeding Consortium and a new report on optimising data on medicines used during pregnancy.
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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 simplified guidance on treating paracetamol overdose with intravenous acetylcysteine including an updated treatment nomogram.
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Extension of the indication for nicotine replacement therapy (NRT) to include harm reduction.
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A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices.
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Recent information relating to COVID-19 vaccines and medicines that has been published since the October 2021 issue of Drug Safety Update, up to 12 November 2021.
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Monitoring blood concentrations of clozapine (Clozaril, Denzapine, Zaponex) for toxicity is now advised in certain clinical situations. Blood level monitoring of other antipsychotics for toxicity may also be helpful in certa…
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How to reduce risk of illicit use.
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Following a review of the risks associated with use of opioid medicines for non-cancer pain, the Commission on Human Medicines (CHM) has recommended that fentanyl transdermal patches are contraindicated in opioid-naive patients in the UK.…
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May cause skin irritation, particularly in children with eczema, possibly due to sodium lauryl sulfate content.
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Infusion reactions and hypersensitivity reactions have been reported commonly during treatment with Avastin.
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Advice on how to use cough and cold medicines safely for children under 12 years.
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Letters were sent about Insuman insulin products, mecasermin, and valproate medicines. Recalls were issued about ranitidine medicines and Paclitaxel.
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A UK and Europe-wide review of available efficacy and safety data confirmed that reboxetine has benefit over placebo in its authorised indication.
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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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Atomoxetine is associated with treatment-emergent psychotic or manic symptoms in children and adolescents - consider stopping this if symptoms occur.
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We inform healthcare professionals that the Medicines and Healthcare products Regulatory Agency (MHRA) has launched new guidance to highlight the latest safety advice on the steps to take during anaphylaxis. This new guidanc…
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Warnings about the risk of severe and fatal burns are being extended to all paraffin-based emollients regardless of paraffin concentration. Data suggest there is also a risk for paraffin-free emollients. Advise patients who …
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Marketing authorisations for carisoprodol are to be suspended after a European review concluded that the risks of treatment outweigh the benefits.
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A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices, and a recent National Patient Safety Alert asking organisations to put a plan in place to implement new regu…
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Anti-cancer therapy with carfilzomib has been associated with cases of cardiac arrest, cardiac failure, and myocardial infarction, including in patients without pre-existing cardiac disorders. Monitor patients for signs and …