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Prescribers should consider reducing the dose of ponatinib to 15 mg a day for patients with chronic phase chronic myeloid leukaemia (CP-CML) who have achieved a major cytogenetic response.
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Patients who require a liquid oral formulation of a β-agonist should be switched to a more-selective short-acting β2-agonist such as salbutamol or terbutaline.
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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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Reminder to test liver function before and during treatment.
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Avoid concomitant use of amiodarone with simeprevir (Olysio▼) and sofosbuvir (Sovaldi▼) combination therapy, unless other antiarrhythmics cannot be given.
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INR should be monitored closely during treatment of chronic hepatitis C with direct-acting antivirals in patients also receiving vitamin K antagonists (eg, warfarin), because of possible changes in liver function during trea…
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Care must be taken with dosing as the 2 products are not equivalent.
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A pooled analysis has shown an increased rate of new primary malignancies in patients given Xgeva (1-year cumulative incidence 1.1%) compared with those given zoledronic acid (0.6%), when used in the indication of the preven…
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There have been reports of rejection of solid organ transplants in patients treated with nivolumab or pembrolizumab. Ipilimumab (Yervoy▼) may also interfere with immunosuppressive therapy, increasing the risk of graft reject…
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We have received reports of depression and, in rare cases, suicidal thoughts in men taking finasteride 1 mg (Propecia) for male pattern hair loss. Be aware that depression is also associated with finasteride 5 mg (Proscar).
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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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Pharmacists should tell people about the risk of fire when they discuss head lice eradication options.
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Further information is available to support safer use
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Prescribing information has been updated to help to minimise the risk of serious adverse reactions in patients with cardiac disease.
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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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MHRA has received a small number of reports suggesting lack of efficacy (thromboembolic events) in patients taking 15 mg or 20 mg rivaroxaban on an empty stomach; remind patients to take 15 mg or 20 mg rivaroxaban tablets wi…
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Avoid concomitant use of amiodarone with ledipasvir-sofosbuvir (Harvoni▼), and amiodarone with sofosbuvir (Sovaldi▼) and daclatasvir (Daklinza▼), unless other antiarrhythmics cannot be given.
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Mirabegron is now contraindicated in patients with severe uncontrolled hypertension; advice about regular monitoring is being introduced because of cases of severe hypertension.
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A recent review of the prescribing information has led to strengthened warnings and new measures to help minimise risks.
To minimise the risk of these adverse reactions, mefloquine must not be used for chemoprophylaxis in…
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Prescribers should be vigilant for possible thrombotic adverse reactions.
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All patients should be screened for hepatitis B before starting treatment for chronic hepatitis C with direct-acting antiviral interferon-free regimens. Patients who are co-infected with hepatitis B and C viruses are at risk…
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Please be vigilant as life-threatening errors may occur
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While an urgent EU safety review evaluates reports of serious cardiovascular events and immune-mediated reactions, including autoimmune hepatitis, the use of alemtuzumab (Lemtrada) has been restricted and strengthened requir…
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Children exposed to valproate in utero are at high risk of developmental disorders and congenital malformations. Use the new communication materials below to discuss these risks with patients
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The authorised dose regimen for N-acetylcysteine (NAC) in paracetamol overdose is 3 consecutive bags given intravenously over 21 hours. Prescribing information is being updated to advise that continued treatment with NAC may…
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Do not use in closed body cavities or on deep or large wounds.
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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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Denosumab is associated with a risk of osteonecrosis of the jaw, osteonecrosis of the external auditory canal has also been reported with denosumab.
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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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Healthcare professionals should advise patients and/or carers of the changes in the dose, packaging, dose dispenser and leaflet.
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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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Following receipt of a third case of fatal medication error caused by the administration of Fungizone (a non-lipid-based formulation of amphotericin B) instead of a lipid-based formulation (AmBisome, Abelcet), we remind heal…
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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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Although use of valproate medicines in female patients continues to slowly decline, there is wide variation in prescribing between Clinical Commissioning Groups (CCGs). Women continue to report instances when they have not r…
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Use alternative vaccines in under 5s and report suspected adverse reactions
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Continued monitoring of medicines with a black triangle status.
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Reports of acquired haemophilia have been received in association with clopidogrel.
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Canagliflozin may increase the risk of lower-limb amputation (mainly toes) in patients with type 2 diabetes. Evidence does not show an increased risk for dapagliflozin and empagliflozin, but the risk may be a class effect. P…
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All products to be named and prescribed as caffeine citrate.
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Use a lower starting dose of thalidomide in patients with untreated multiple myeloma who are older than age 75 years.
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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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Possible increased risk of retinopathy with epoetin beta in premature infants calls for careful consideration of options for preventing anaemia of prematurity.
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Patients should be tested for hepatitis B virus before starting treatment with BCR-ABL tyrosine kinase inhibitors.
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Test for raised ketones in patients with acidosis symptoms, even if plasma glucose levels are near-normal.
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Patients receiving apomorphine and domperidone require an assessment of cardiac risk factors and ECG monitoring to reduce the risk of serious arrhythmia related to QT-prolongation.
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Central serous chorioretinopathy is a retinal disorder that has been linked to the systemic use of corticosteroids. Recently, it has also been reported after local administration of corticosteroids via inhaled and intranasal…
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Cases of intraoperative floppy iris syndrome (IFIS) during cataract surgery have been reported in patients taking the atypical antipsychotics risperidone or paliperidone.
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Reports of pigment changes in ocular tissue, skin, lips or nails.
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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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Consider progressive multifocal encephalopathy (PML) in the differential diagnosis for patients with new or worsening neurological signs or symptoms, even several years after treatment with cladribine.