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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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Strengthening surveillance of medicines throughout the EU
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(Dextro)propoxyphene can have serious effects on the electrical activity of the heart (resulting in prolongation of the P-R and Q-T intervals, and widened QRS complexes), even at normal therapeutic doses.
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Linezolid is not active against infections caused by Gram-negative pathogens, and treatment should be started only after specialist microbiological advice.
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Gabapentin has been associated with a rare risk of severe respiratory depression even without concomitant opioid medicines. Patients with compromised respiratory function, respiratory or neurological disease, renal impairmen…
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Healthcare professionals should be aware of the updated information so they can discuss it with new and existing patients.
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Reminder to monitor and manage weight, glucose, and lipid levels.
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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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Risk of thrombosis and haemorrhage in patients with prosthetic heart valve(s) requiring anti-coagulant treatment.
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New safety recommendations have been issued while an EU review evaluates cases of neural tube defects in babies born to mothers who became pregnant while taking the HIV medicine dolutegravir.
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Use restricted to adults with advanced or metastatic breast cancer only.
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Atypical femoral fractures reported rarely with bisphosphonate therapy, mainly in patients receiving long-term treatment for osteoporosis.
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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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Advice for healthcare professionals on the reclassification of codeine linctus to a prescription-only medicine (POM), following a public consultation.
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The risk of foetal malformation with oral retinoids is extremely high, even when used at a low dose or for a short time during pregnancy. All oral retinoids have an associated Pregnancy Prevention Programme (PPP), which is s…
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There are new interim treatment recommendations for idelalisib for chronic lymphocytic leukaemia and follicular lymphoma in light of new findings from clinical trials outside its currently authorised drug combinations or ind…
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Codeine should only be used to relieve acute moderate pain in children older than 12 years and only if it cannot be relieved by other painkillers such as paracetamol or ibuprofen alone.
Furthermore, a significant risk of se…
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Monitor patients for signs and symptoms of hypercalcaemia after discontinuation of denosumab treatment for giant cell tumour of bone. Cases of rebound hypercalcemia have been reported up to 9 months after cessation of treatm…
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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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New data have confirmed that the risk of breast cancer is increased during use of all types of HRT, except vaginal estrogens, and have also shown that an excess risk of breast cancer persists for longer after stopping HRT th…
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Perform a quantitative serum anti-JCV antibody test—including index value—to support risk stratification for progressive multifocal leukoencephalopathy. For high-risk patients, consider more frequent MRI screening.
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Risk of tuberculosis - screen all patients before starting treatment and monitor them closely.
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There have been reports of worsening nasal congestion (rebound congestion) when the effects of nasal decongestant sprays or drops containing xylometazoline hydrochloride and oxymetazoline hydrochloride, wear off.
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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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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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The use of daclizumab (daclizumab beta) is now restricted to adults with relapsing multiple sclerosis who have had an inadequate response to at least 2 other disease-modifying therapies (DMTs) and for whom other DMTs are con…
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Use materials online now and hardcopies arriving over the coming weeks by post to ensure women and girls of childbearing potential on valproate medicines meet the requirements of the Pregnancy Prevention Programme.
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The European Medicines Agency (EMA) has recommended the immediate suspension of the marketing authorisation and recall of daclizumab (Zinbryta) in the EU following reports of serious inflammatory brain disorders, including e…
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Prescribers should be aware of the risk of potentiation of radiation toxicity with vemurafenib when given before, during, or after radiotherapy
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Letters were sent about Oncaspar▼ (pegaspargase), Ketalar (ketamine) injection, and Elmiron (pentosan polysulfate sodium). A recall was issued for several medicines taken out of the regulated medicines supply chain, includin…
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Insufficient evidence to confirm a link between oral bisphosphonate use and an increased risk of oesophageal cancer.
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All patients with cancer should have a dental check-up before bisphosphonate treatment.
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Healthcare professionals prescribing fluoroquinolone antibiotics (ciprofloxacin, delafloxacin, levofloxacin, moxifloxacin, ofloxacin) are reminded to be alert to the risk of psychiatric reactions, including depression and ps…
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Physicians should remain vigilant for pneumonia and other infections of the lower respiratory tract (ie, bronchitis) in patients with chronic obstructive pulmonary disease who are treated with inhaled products that contain s…
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Calcium salts (either calcium chloride or calcium gluconate) are used to stabilise the myocardium and prevent cardiac arrest in patients experiencing severe hyperkalaemia. However, the two salts are not equivalent in terms o…
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Patients receiving lenalidomide for management of multiple myeloma should be closely monitored for evidence of arterial and venous thromboembolic events.
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SGLT2 inhibitor treatment should be interrupted in patients who are hospitalised for major surgical procedures or acute serious medical illnesses and ketone levels measured, preferably in blood rather than urine. Treatment m…
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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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Healthcare professionals should consider the possibility of second primary malignancy in patients treated with lenalidomide.
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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 patie…
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New warnings due to risk of hyperkalaemia, hypotension, and impaired renal function have been agreed following an EU-wide review.
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Updated safety and educational materials are now available to support the implementation of the regulatory measures announced in the November 2023 National Patient Safety Alert and the September 2024 Drug Safety Update. They…
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Healthcare professionals prescribing aripiprazole are reminded to be alert to the risk of addictive gambling and other impulse control disorders. Healthcare professionals should advise patients, their families and friends to…
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A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices.
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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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For most patients and most medicines, estimated Glomerular Filtration Rate (eGFR) is an appropriate measure of renal function for determining dosage adjustments in renal impairment; however, in some circumstances, the Cockcr…
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A patient alert card is being introduced for men taking finasteride to help raise awareness of the risk of psychiatric side effects and sexual dysfunction, including the potential for sexual dysfunction to persist after trea…
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Idiopathic intracranial hypertension (IIH) has been very rarely reported in patients treated with mesalazine. Following a recent review, warnings for IIH are being added to the product information for all mesalazine products…
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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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Do not use in children aged 16 years or less, except in specialist settings under expert medical supervision.