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Patients should use the lowest effective dose, and the shortest duration of treatment necessary to control symptoms.
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Use trametinib, authorised either as monotherapy or combined with dabrafenib, with caution in patients with risk factors for gastrointestinal perforation.
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Take particular care when prescribing or dispensing medicines that could be confused with others (ie, they sound-alike or look-alike).
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Studies of cardiovascular risk don’t support prescribing changes.
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Serious liver injury has been reported during treatment with pirfenidone in the first year after initiation, including 2 cases with a fatal outcome. Measure alanine aminotransferase (ALT), aspartate aminotransferase (AST), a…
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Confidential reports designed to help you improve the quality of your prescribing and patient safety are now available for practices that contribute to the MHRA’s Clinical Practice Research Datalink.
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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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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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Reminder on risk of serious and fatal toxicity in overdose.
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Remind patients to check and remove the mouthpiece cover properly before inhaling a dose and to shake the inhaler to remove loose objects that may have become trapped in the inhaler during storage. The mouthpiece cover shoul…
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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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Onivyde has been associated with reports of serious thromboembolic events, such as pulmonary embolism, venous thrombosis, and arterial thromboembolism.
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Test liver function before and during treatment and tell patients to avoid sunlight exposure.
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New recommendations after a Europe-wide review of cardiovascular safety.
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Fatal cases of tumour lysis syndrome (TLS) have been reported, some occurring in patients with chronic lymphocytic leukaemia receiving the lowest venetoclax dose used in the dose-titration schedule. For all patients, it is i…
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Risk of serious haemorrhage—clarified contraindications apply to all 3 medicines.
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Updated safety recommendations have been issued as part of the European review evaluating cases of neural tube defects in babies born to mothers who became pregnant while taking the HIV medicine dolutegravir. Evidence collec…
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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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Best practice example of a patient information leaflet.
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Anti-cancer therapy with carfilzomib has been associated with cases of cardiac arrest, cardiac failure, and myocardial infarction, including in patients without pre-existing cardiac disorders.…
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A summary of letters and drug alerts recently sent to healthcare professionals.
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Intrahepatic cholestasis of pregnancy (ICP) has been rarely reported in patients treated with azathioprine products and is believed to be a risk applicable to all drugs in the thiopurine class (azathioprine, mercaptopurine a…
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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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Fatal cases of severe symptomatic hypocalcaemia, and risk of hypocalcaemia at any time during treatment.
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Clinical trials, including interim findings from a randomised trial, show an increased risk of depression, suicidal ideation or behaviour, or self-injury in patients with systemic lupus erythematosus receiving belimumab comp…
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Albumin-bound paclitaxel formulations for infusion (nab-paclitaxel; brand names Abraxane, Pazenir) differ from conventional paclitaxel medicines in their authorised indications, pharmacokinetics, recommended dosages, and pre…
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Licensed doses and differences in potency between different inhaled corticosteroids; advice for use with spacer device.
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Abacavir should be used in line with current treatment guidelines and with caution in patients with high cardiovascular risk factors.
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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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Healthcare professionals should be aware that these capsules contain potential allergens.
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Data suggests that long-term use of carbamazepine, phenytoin, primidone, and sodium valproate is associated with decreased bone mineral density that may lead to osteopenia, osteoporosis, and increased fractures.
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There is a risk of harmful drug interactions with the ritonavir component of the COVID-19 treatment Paxlovid▼ due to its inhibition of the enzyme CYP3A, which metabolises many commonly used drugs. Prescribers should obtain a…
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Cases of pancreatitis, with or without sphincter of Oddi spasm, have been reported in patients taking eluxadoline. Some cases have resulted in hospitalisation and death, primarily in patients who have undergone cholecystecto…
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Monitor serum phosphate levels in patients treated with multiple high-dose administrations, or those on long-term treatment, and in those with pre-existing risk factors for hypophosphataemia. Re-evaluate ferric carboxymaltos…
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Risk of meningioma with cyproterone acetate increases with increasing cumulative dose. Use of cyproterone is contraindicated in patients with previous or current meningioma (for all indications) and should only be considered…
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Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels should be measured before starting treatment with tocilizumab and monitored every 4–8 weeks for the first 6 months of treatment followed by every 12 …
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Patients with complete or partial dihydropyrimidine dehydrogenase (DPD) deficiency are at increased risk of severe and fatal toxicity during treatment with these medicines. All patients should be tested for DPD deficiency be…
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Now only authorised for use in patients with symptomatic bone metastases and no known visceral metastases who have had 2 previous systemic treatments for metastatic castration-resistant prostate cancer or who cannot receive …
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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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Maintenance doses of brolucizumab (after the first 3 doses) should not be given at intervals of less than 8 weeks apart.
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The study found no clear evidence that varenicline was associated with an increased risk of fatal or non-fatal self-harm.
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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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Topiramate is now contraindicated in pregnancy and in women of childbearing potential unless the conditions of a Pregnancy Prevention Programme are fulfilled. This follows a review by the MHRA which concluded that the use of…
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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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Caution is required if prescribing febuxostat in patients with pre-existing major cardiovascular disease, particularly, in those with evidence of high urate crystal and tophi burden or those initiating urate-lowering therapy…
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The Isotretinoin Expert Working Group of the Commission on Human Medicines has made recommendations to strengthen the safety of isotretinoin treatment. Recommendations include new warnings, the need for consistent monitoring…
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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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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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There have been reports of thrombotic microangiopathy and nephrotic syndrome linked to interferon beta treatment.
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Statin use may be associated with a level of hyperglycaemia in some patients where formal diabetes care is appropriate.