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If a patient reports persistent symptoms when switching between different levothyroxine tablet formulations, consider consistently prescribing a specific product known to be well tolerated by the patient. If symptoms or poor…
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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 and notifications sent to healthcare professionals about medicines.
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Recent information relating to COVID-19 vaccines and medicines that has been published since the November 2021 issue of Drug Safety Update, up to 3 December 2021.
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A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices and details of two recent MHRA National Patient Safety Alerts to remove from service Philips Health Systems V…
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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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Psychological side effects such as anxiety, low mood, sleep disturbance, poor concentration, and forgetfulness have been infrequently reported in people with cystic fibrosis treated with Kaftrio. Healthcare professionals sho…
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Topical oral salicylate gels are no longer indicated for people younger than 16 years for pain associated with infant teething, orthodontic devices, cold sores, or mouth ulcers.
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Following a review of the available toxicological data and a calculation of daily exposure to boron from a typical dosing regimen, we have concluded that the balance between the benefits and risks of chloramphenicol eye drop…
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Rare occurrence of serious allergic reactions should not preclude use of parenteral thiamine in patients who need treatment by this route of administration.
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If patients are known to be HLA-B*1502-positive, phenytoinshould be avoided when alternative therapy can be given.
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We inform healthcare professionals that the Medicines and Healthcare products Regulatory Agency (MHRA) has launched new guidance to highlight the latest safety advice on the steps to take during anaphylaxis. This new guidanc…
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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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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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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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How MHRA monitors the impact of regulatory action taken.
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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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SSRIs and SNRIs are known to increase bleeding risks due to their effect on platelet function. Data from observational studies suggest that the use of SSRI/SNRI antidepressants during the month before delivery may result in …
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The Commission on Human Medicines (CHM) has endorsed changes to the risk minimisation measures for isotretinoin, following a review of the impact of the measures implemented in 2023.…
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Be vigilant for any suspected adverse reactions associated with use of e-cigarettes or vaping (including lung injury) and report them to the MHRA via the Yellow Card scheme. In this article we provide UK case definitions of …
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Solu-Medrone 40 mg may contain trace amounts of milk proteins. Do not use in patients with a known or suspected allergy to cows’ milk.
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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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Monitoring for encephalitis should continue for 12 months following discontinuation of daclizumab. Inform all patients who have discontinued daclizumab and their caregivers of the common symptoms of encephalitis and the need…
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A letter was sent about injectable methylprednisolone products containing lactose (Solu-Medrone 40 mg); do not use in patients allergic to cow’s milk proteins.
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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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Patients on ipilimumab who present with diarrhoea or other symptoms of colitis, and those who do not respond to steroid treatment for immune-related colitis, should be investigated to exclude other causes, including infectio…
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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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Detailed recommendations for dose restrictions when used with some other drugs as interactions may increase the risk of adverse effects, or reduce the effectiveness of statin treatment.
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Second year safety review
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Cutaneous amyloidosis at the injection site has been reported in patients using insulin and this may affect glycaemic control. Remind patients to rotate injection sites within the same body region.
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Patients with cancer who received recombinant human erythropoietins in clinical trials had an increased risk of tumour progression and reduced overall survival compared with study controls.…
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Over-correction of haemoglobin concentration may increase the risk of death and serious cardiovascular events in patients with chronic kidney disease; it may increase the risk of thrombosis and related complications in patie…
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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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Suspension of the marketing authorisations of rosiglitazone (Avandia, Avandamet) recommended across the European Union.
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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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The human papillomavirus (HPV) immunisation programme is now entering its second year and this article summarises the safety experience to date.
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Suspension of the licences (marketing authorisations) for Octagam (intravenous human normal immunoglobulin 5% and 10%) lifted.
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The Commission on Human Medicines (CHM) has temporarily restricted use of the IXCHIQ Chikungunya vaccine in people aged 65 years and over following very rare fatal reactions reported globally. This is a precautionary measure while the MHRA conducts a safety review.…
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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.…
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Mycophenolate mofetil and its active metabolite mycophenolic acid, both used to prevent transplant rejection, are teratogenic and genotoxic. The available clinical evidence does not indicate an increased risk of malformation…
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Recombinant human erythropoietin (r-HuEPO) treatment has been associated with very rare cases of life-threatening severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN).…
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The European Medicines Agency has advised that no change in recommendations for use is required at present.
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A safety review conducted at the end of its routine use during the ongoing human papillomavirus immunisation programme has found that no new risks have been identified for Cervarix, and that the balance of its risks and benefits remains clearly positive.…
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The Commission on Human Medicines recommend that existing levels of monitoring, education, and awareness measures by pharmacists should be maintained.
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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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The design and content of the Patient Information Leaflets for methylphenidate products are being updated with the latest guidance on safe and effective use for patients and carers
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The MHRA has reviewed the evidence for finasteride and dutasteride and the risk of suicidal thoughts and behaviours and has recommended further measures to minimise this risk.
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Cases of benign and malignant neoplasms have been observed among children and adolescents who received treatment with mecasermin. Do not use mecasermin in children or adolescents with active or suspected neoplasia or with an…
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…Following advice from the Commission on Human Medicines (CHM), new safety measures for valproate-containing medicines are to be put in place in the coming months.
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Following the completion of a safety review and the recommendations of the Commission on Human Medicines (CHM), the IXCHIQ Chikungunya vaccine is no longer indicated for adults over the age of 60 years, and is contraindicated in all individuals with hypertension, cardiovascular disease…