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Reports of pigment changes in ocular tissue, skin, lips or nails.
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Care needed when transferring from unlicensed formulations.
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Doses of theophylline, fluvoxamine, caffeine, coumarins including warfarin and the antipsychotics clozapine and olanzapine may have to be altered.
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Use of pioglitazone is associated with a small increased risk of bladder cancer. Healthcare professionals should be aware of new warnings and precautions for use in at-risk patients
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New specific guidance on dose-dependent prolongation of QTc with ondansetron.
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There is an increased risk of myopathy associated with high-dose (80 mg) simvastatin. The 80-mg dose should be considered only in patients with severe hypercholesterolaemia and high risk of cardiovascular complications who h…
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Quinine should only be considered when cramps cause regular disruption of sleep.
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The most important risk factors for uterine perforation are insertion during lactation and insertion in the 36 weeks after giving birth. Before inserting an IUS or IUD, inform women of the risk and the symptoms of perforatio…
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Updated prescribing advice provided.
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Liver function should be tested before and during treatment with temozolomide.
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New recommendations are being introduced to minimise the risk of serious hypersensitivity reactions with ferumoxytol.
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liver-function testing recommended in patients with symptoms that may indicate liver injury.
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Dental examination and appropriate preventive dentistry should be considered before treatment, especially for patients also treated with an intravenous bisphosphonate.
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New monitoring instructions to detect these side effects as soon as possible.
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New simplified guidance on treating paracetamol overdose with intravenous acetylcysteine including an updated treatment nomogram.
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Risk of tuberculosis - screen all patients before starting treatment and monitor them closely.
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Check full blood counts before prescribing dimethyl fumarate and then every 6 to 12 months. Stop treatment immediately if you suspect progressive multifocal leukoencephalopathy.
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Remember to report any suspected adverse reactions
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New contraindications, warnings, and advice for monitoring.
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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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Valproate medicines must not be used in women of childbearing potential unless the Pregnancy Prevention Programme is in place. If you are involved in the care of female patients on valproate in the UK, see a reminder of acti…
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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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New maximum daily dose restrictions (including in elderly patients), contraindications, and warnings.
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Monitor patients closely for skin cancers. Advise patients to seek urgent attention if they develop signs or symptoms of serious infections.
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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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To be used only in patients with acute blood loss and when crystalloids alone are not sufficient.
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Updated advice for healthcare professionals is available, after conclusion of a review of the safety of idelalisib, including the risk of infection.
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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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Healthcare professionals should consider the possibility of second primary malignancy in patients treated with lenalidomide.
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There have been rare reports of Nexplanon implants having reached the lung via the pulmonary artery. An implant that cannot be palpated at its insertion site in the arm should be located as soon as possible and removed at th…
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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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Risk of accidental overdose, particularly in infants and neonates.
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Repeat enhanced cardiovascular monitoring when restarting fingolimod after treatment interruption,
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A signal of increased lower limb amputation (primarily of the toe) in people taking canagliflozin compared with placebo in a clinical trial in high cardiovascular risk patients is currently under investigation.
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The risk of developing progressive multifocal leukoencephalopathy (PML) with natalizumab increases after 2 years of therapy. Patients with multiple sclerosis should be informed of the risk before treatment, and again after 2…
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A summary of letters and drug alerts recently sent to healthcare professionals.
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Routine monitoring of liver function now recommended.
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New strengthened recommendations to manage and minimise risk.
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Outline of the safety experience of these medicines in the UK from our proactive safety monitoring strategy.
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A summary of letters and drug alerts recently sent to healthcare professionals.
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A summary of letters and drug alerts recently sent to healthcare professionals.
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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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Letters were sent about Myocrisin (sodium aurothiomalate), Cerliponase alfa (Brineura▼), Darzalex▼(daratumumab), retinoids▼, and febuxostat (Adenuric). A recall alert was issued for medicines that were taken out of the regul…
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How pharmacists can prevent counterfeits reaching patients.
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In 2008 MHRA commissioned Ipsos MORI to research the public’s perception of herbal medicines, the findings may help doctors and pharmacists when considering how to advise patients.
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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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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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Monitoring of blood electrolytes is essential in patients coprescribed a potassium-sparing diuretic and an angiotensin converting enzyme inhibitor (ACEi) or an angiotensin receptor blocker (ARB) for heart failure.
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Temporarily discontinue ibrutinib in patients who develop symptoms suggestive of ventricular arrhythmia and assess benefit-risk before restarting therapy. Establish hepatitis B virus status before initiating ibrutinib. Consi…
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Mycophenolate mofetil and its active metabolite mycophenolic acid are associated with a high rate of serious birth defects and increased risk of spontaneous abortion.