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Mothers who are breastfeeding should not take ACE inhibitors or angiotensin II receptor antagonists in the first few weeks after delivery.…
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Use in women who are planning pregnancy should be avoided unless absolutely necessary, in which case the potential risks and benefits should be discussed
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Use during breastfeeding
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Evidence does not support any increased risk of cancer in patients who use these medicines.
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You should take caution when you use NSAIDs in patients with renal impairment or are at risk.
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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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Advise patients taking hydrochlorothiazide-containing products of the cumulative, dose-dependent risk of non-melanoma skin cancer, particularly in long-term use, and the need to regularly check for (and report) any suspiciou…
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In light of feedback, we have clarified our article on concomitant use of these medicines in heart failure.
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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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Key MHRA advice and guidance issued so far on medicines safety and pharmacovigilance, including on reporting to the Yellow Card Scheme.
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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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Healthcare professionals should advise patients who need re-vaccination with Pneumovax II to expect a more intense reaction than after their first vaccination.
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Patients with pulmonary hypertension associated with idiopathic interstitial pneumonias should not be treated with riociguat in light of interim results from a recently terminated study.
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Patients should be advised to promptly report to their doctor any changes in their breast tissue such as lumps, pain, or nipple discharge.
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An alert was issued recently about Accu-Chek Aviva, Accu-Chek Performa, and Accu-Chek Inform II test strips – risk of strip error messages and false high and low blood glucose results. An alert was also issued recently about Infinity Acute Care System and M540 Patient Monitors.
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An alert was recently issued by MHRA on JM103 and JM105 Jaundice Meters. We also remind you of an alert about Accu-Chek blood glucose test strips.
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Aceclofenac is now contraindicated in patients with certain established cardiovascular diseases.
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Calciphylaxis is a very rare but serious condition causing vascular calcification and skin necrosis.
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A summary of recent letters, medicine recalls and notifications sent to healthcare professionals
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A summary of recent letters and notifications sent to healthcare professionals about medicines, and a recent National Patient Safety Alert highlighting the risk of deaths and serious injuries from entrapment or falls relatin…
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Emerging clinical trial evidence of increased cardiovascular risk.
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importance of establishing wild type RAS (KRAS and NRAS) status before treatment of metastatic colorectal cancer
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Risk of thrombosis and haemorrhage in patients with prosthetic heart valve(s) requiring anti-coagulant treatment.
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Use restricted to adults with advanced or metastatic breast cancer only.
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Fingolimod can cause persistent bradycardia, which can increase the risk of serious cardiac arrhythmias. New contraindications have been introduced for patients with pre-existing cardiac disorders.
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New recommendations after a Europe-wide review of cardiovascular safety.
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Increased risk of arterial thromboembolism, including myocardial infarction and cerebrovascular events for patients treated with thalidomide.
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EU review confirms that the cardiovascular risk of high-dose ibuprofen (≥2400mg/day) is similar to COX 2 inhibitors and diclofenac.
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Indication restricted to second-line treatment and contraindicated with some cardiovascular conditions and medicines
Furthermore, cilostazol is now contraindicated in patients with any of the following:
Unstable ang…
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Recent clinical trials have shown increased mortality when bendamustine (Levact) was used in combination treatments outside its approved indications. Be aware that the risk of opportunistic infections for all patients receiv…
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Contraindications clarified and reminder to monitor renal function.
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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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Decreased vitamin B12 levels, or vitamin B12 deficiency, is now considered to be a common side effect in patients on metformin treatment, especially in those receiving a higher dose or longer treatment duration and in those …
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Healthcare professionals are reminded to inform patients about the common and serious side effects associated with glucagon-like peptide-1 receptor agonists (GLP-1RAs).
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Periodically perform skin examinations in patients on bendamustine-containing regimens and consider PML in the differential diagnosis for patients on bendamustine with new or worsening neurological, cognitive, or behavioural…
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Healthcare professionals should be aware of the potential risk of pulmonary aspiration in patients using GLP-1 or dual GIP/GLP-1 receptor agonists who undergo surgery or procedures with general anaesthesia or deep sedation.