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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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A safety review conducted at the end of its routine use during the ongoing human papillomavirus immunisation programme has found that no new risks have been identified for Cervarix, and that the balance of its risks and bene…
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The Commission on Human Medicines recommend that existing levels of monitoring, education, and awareness measures by pharmacists should be maintained.
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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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The maximum recommended dose for simvastatin in conjunction with amlodipine and diltiazem is now 20 mg/day.
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Fatal cases of severe symptomatic hypocalcaemia, and risk of hypocalcaemia at any time during treatment.
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Liver function tests should be carried out at treatment initiation, during treatment, and also when the dose is increased.
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Do not use in children aged 16 years or less, except in specialist settings under expert medical supervision.
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New simplified guidance on treating paracetamol overdose with intravenous acetylcysteine including an updated treatment nomogram.
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There have been reports of acute pancreatitis associated with drugs in the dipeptidylpeptidase-4 (DPP-4) inhibitor class of antidiabetic agents (‘gliptins’).
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Healthcare professionals should advise patients and/or carers of the changes in the dose, packaging, dose dispenser and leaflet.
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Five cases of necrotising fasciitis have been reported in patients treated with panitumumab in combination with chemotherapy.
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Levofloxacin (a fluoroquinolone antibiotic) is unfavourable as first-line treatment for several indications.
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Calcitonin-containing medicines should no longer be used in treatment of osteoporosis.
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New maximum single intravenous dose of ondansetron for the management of chemotherapy-induced nausea and vomiting (CINV) restricted due to risk of QTc prolongation.
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Previous dosing regimens for doripenem in such patients found to be insufficient.
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Updated contraindications and maximum dose recommendations when taken with a number of other medicines.
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Contraindications clarified and reminder to monitor renal function.
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False blood glucose readings when used to flush arterial lines leading to incorrect insulin administration and potentially fatal hypoglycaemia.
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The growing number of oral tacrolimus products available on the market increases the potential for inadvertent switching between products, which has been associated with reports of toxicity and graft rejection. Therefore, to…
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Healthcare professionals reminded that tacrolimus may be associated with possible risk of malignancy.
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Febuxostat must be stopped immediately if hypersensitivity occurs and must not be re-started in patients who have ever developed a hypersensitivity reaction to febuxostat.
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Care must be taken with dosing as the 2 products are not equivalent.
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New advice for extended early monitoring for those with significant bradycardia or heart block after first dose.
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Patients who present with acute or worsening signs and symptoms of keratitis should be referred promptly to an ophthalmology specialist.
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Concerns over recent years about the use of antipsychotics to treat the behavioural and psychological symptoms of dementia (BPSD).
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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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Recent epidemiological evidence of an increased risk of fracture with long-term use of proton pump inhibitors (PPIs).
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Healthcare professionals should consider measuring magnesium levels before starting PPI treatment and repeat measurements periodically during prolonged treatment.
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New contraindications and warnings for combination of aliskiren (Rasilez) with angiotensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs).
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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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Healthcare professionals should be aware that these capsules contain potential allergens.
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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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Healthcare professionals are reminded that chlorhexidine is known to induce hypersensitivity, including generalised allergic reactions and anaphylactic shock.
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How to comment on new pharmacovigilance legislation.
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Statin use may be associated with a level of hyperglycaemia in some patients where formal diabetes care is appropriate.
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New contraindications, warnings, and advice for monitoring.
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Evidence does not support any increased risk of cancer in patients who use these medicines.
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New maximum daily dose restrictions (including in elderly patients), contraindications, and warnings.
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Healthcare professionals should consider the possibility of second primary malignancy in patients treated with lenalidomide.
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Reminder that paediatric paracetamol liquids had been developed to ensure children receive optimum dosing for their age.
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Following new evidence of cardiovascular, hepatic and pulmonary risk, a review of dronedarone has concluded that the benefits of treatment continue to outweigh the risks for the maintenance of sinus rhythm after successful c…
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Don't apply aqueous calamine cream onto the skin before an X-ray examination because it may affect the outcome of the radiograph.
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Use alternative vaccines in under 5s and report suspected adverse reactions
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Studies of cardiovascular risk don’t support prescribing changes.
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Care needed when transferring from unlicensed formulations.
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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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Risk of extrapyramidal effects or withdrawal symptoms (or both) in newborns after maternal use of antipsychotics during the third trimester of pregnancy.
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There is a risk of rhabdomyolysis if Systemic fusidic acid (Fucidin) is given with statins.
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Onsenal▼ (celecoxib) is no longer approved in Europe for the reduction of intestinal polyps in familial adenomatous polyposis (FAP).