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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 necro…
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Letters were sent about cladribine (Litak and Leustat), radium-223-dichloride (Xofigo▼), and ERWINASE.
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Alerts were recently issued about BD Alaris/Asena syringe pumps and Maxter Catheters nasogastric (NG) feeding tubes.
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A European review has begun into the safety of radium-223 dichloride following an observed increase in the incidence of deaths and fractures in patients with chemotherapy-naive metastatic castration-resistant prostate cancer…
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Some batches of gentamicin sulphate active pharmaceutical ingredient (API) used to manufacture gentamicin may contain higher than expected levels of histamine, which is a residual from the manufacturing process. Monitor pati…
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Letters were sent in September about Dacogen (decitabine), Eperzan▼(albiglutide), ERWINASE, ReoPro (abciximab), and recombinant human erythropoietins.
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An alert was recently issued about Prismaflex haemofiltration machines.
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Letters were sent about Arsenic Trioxide (Trisenox), Uptravi▼ (selexipag), DepoCyte (cytarabine), Cinryze▼ (C1 esterase inhibitor [human]), and Clexane (enoxaparin sodium).
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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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A summary of letters sent to healthcare professionals, including an important reminder about the withdrawal of retigabine (Trobalt) from the market.
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Babies born to mothers who take valproate medicines (Epilim▼, Depakote▼) during pregnancy have a 30–40% risk of developmental disability and a 10% risk of birth defects. Despite communications to prescribers in January 2015 …
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A summary of letters sent to relevant healthcare professionals.
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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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A summary of letters sent to relevant healthcare professionals in January 2017.
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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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In light of feedback, we have clarified our article on concomitant use of these medicines in heart failure.
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A summary of recent safety letters sent to relevant healthcare professionals
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A summary of letters sent to healthcare professionals in September 2016, including important information for professionals who specialise in epilepsy treatment regarding the withdrawal from the market of retigabine (Trobalt).
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Medicines or herbal remedies that induce CYP3A4 enzymes reduce blood levels of levonorgestrel, which may reduce emergency contraceptive efficacy.
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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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In May 2016, letters were sent regarding Nexplanon (etonogestrel implant) and ERWINASE.
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In February 2016, a letter was sent to healthcare professionals regarding medicines containing valproate.
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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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Levonorgestrel-releasing intrauterine systems should always be prescribed by brand name because products have different indications, durations of use, and introducers.
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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.
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In November, letters were sent regarding thalidomide, mycophenolate mofetil, nicorandil, InductOs, and dimethyl fumarate
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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 letter was sent to healthcare professionals about mirabegron for symptomatic treatment of urgency, increased
micturition frequency, or urgency incontinence.
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Patient reminder cards about the risk of osteonecrosis of the jaw are being introduced; denosumab 120 mg is now contraindicated in patients with unhealed lesions from dental or oral surgery.
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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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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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The licence-holder of ferumoxytol has voluntarily withdrawn it from the UK market for commercial reasons.
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The new module helps clinicians understand how to identify, manage and avoid side effects when using corticosteroids.
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Since November 2014, letters were sent regarding vismodegib (Erivedge ▼), chlorhexidine solutions, carbocisteine oral liquid (Mucodyne Paediatric 125mg/5ml), regadenoson (Rapiscan), a parenteral nutrition emulsion (Triomel),…
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A short course (3 to 7 days) may be used with caution in certain patients with an eGFR of 30 to 44 ml/min/1.73m2
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Children exposed in utero to valproate are at a high risk of serious developmental disorders (in up to 30-40% of cases) and/or congenital malformations (in approximately 10% of cases).
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Reports of reconstituted solution leaking from some models of extension sets and pumps.
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There have been reports of thrombotic microangiopathy and nephrotic syndrome linked to interferon beta treatment.
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Minimising the risk of osteonecrosis of the jaw; monitoring for hypocalcaemia.
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New recommendations are being introduced to minimise the risk of serious hypersensitivity reactions with ferumoxytol.
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Emergency contraceptives remain suitable for all women regardless of the woman’s weight or body mass index (BMI).
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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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Reporting suspected adverse reactions experienced by the woman or child associated with medicines taken during pregnancy.
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Non-hormonal or progestogen-only contraception should be considered in some situations.
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St John’s wort interacts with hormonal contraceptives reducing the effectiveness and increasing the risk of unplanned pregnancy.
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A review of the latest evidence on the risk of thromboembolism advises to consider risk factors and remain vigilant for signs and symptoms.
- the risk of blood clots with all low-dose CHCs is small
- there is good evid…
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Not for use in pregnancy unless there is no effective alternative.
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Use has been restricted to 48 hours’ maximum parenteral use under specialist supervision, after a European safety review.
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Clarification of advice on new recommendations regarding initial test dose.
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All products to be named and prescribed as caffeine citrate.