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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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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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Unless there are exceptional circumstances, valproate-containing medicines must always be dispensed in the manufacturer’s original full pack.
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Evidence does not support any increased risk of cancer in patients who use these medicines.
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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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Calcitonin-containing medicines should no longer be used in treatment of osteoporosis.
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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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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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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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Mixing drugs together, where one is not a vehicle for the administration of the other, creates an unlicensed medicine.
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Avoid concomitant use of amiodarone with simeprevir (Olysio▼) and sofosbuvir (Sovaldi▼) combination therapy, unless other antiarrhythmics cannot be given.
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All products to be named and prescribed as caffeine citrate.
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A summary of advice recently issued by the MHRA relating to coronavirus (COVID-19), up to 16 February 2021.
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Strengthening surveillance of medicines throughout the EU
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Avoid concomitant use of amiodarone with ledipasvir-sofosbuvir (Harvoni▼), and amiodarone with sofosbuvir (Sovaldi▼) and daclatasvir (Daklinza▼), unless other antiarrhythmics cannot be given.
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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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Continued monitoring of medicines with a black triangle status.
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From October 2014 Dexamethasone 4 mg/ml injection (Organon Laboratories Limited) will be replaced by Dexamethasone 3.8 mg/ml solution for injection (Aspen Pharma Trading Limited).
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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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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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As of 1 April 2019, pregabalin and gabapentin are controlled under the Misuse of Drugs Act 1971 as Class C substances and scheduled under the Misuse of Drugs Regulations 2001 as Schedule 3.…
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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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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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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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Spontaneous reporting on the Yellow Card portal has provided important information in the identification of PML associated with some drugs.
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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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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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Photosensitivity reactions are known side effects of methotrexate treatment and can be severe. Patients should be advised to take precautions to protect their skin in the sun.
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Recent information relating to COVID-19 vaccines and medicines that has been published since the July 2022 issue of Drug Safety Update, up to 19 August 2022.
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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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Reporting suspected adverse reactions experienced by the woman or child associated with medicines taken during pregnancy.
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A letter was sent to advise healthcare professionals about a restriction to the indication and route of administration for Mitomycin-C Kyowa 40 mg following the observation of increased sub-visible particles in the drug product on storage.…
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May cause skin irritation, particularly in children with eczema, possibly due to sodium lauryl sulfate content.
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Extension of the indication for nicotine replacement therapy (NRT) to include harm reduction.
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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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Monitor thyroid-stimulating hormone (TSH) in patients treated with levothyroxine for at least the first month after starting and ending ritonavir treatment.
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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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New simplified guidance on treating paracetamol overdose with intravenous acetylcysteine including an updated treatment nomogram.
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How to reduce risk of illicit use.
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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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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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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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A large study has shown no safety issues of concern relating to the use of metformin during pregnancy. The licence for metformin now reflects that it can be considered for use during pregnancy and the periconceptional phase …
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An alert was issued about Dialog+ haemodialysis machines.
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Advice on how to use cough and cold medicines safely for children under 12 years.
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All patients with cancer should have a dental check-up before bisphosphonate treatment.
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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 …