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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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The MHRA has reviewed the warnings regarding addiction, dependence, withdrawal, and
tolerance for gabapentin, pregabalin, benzodiazepines, and z-drugs. The findings (detailed in the Public Assessment Report) were that it wa…
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Quinine has dose-dependent QT-interval-prolonging effects and should be used with caution in patients with risk factors for QT prolongation or in those with atrioventricular block.
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Minimising the risk of osteonecrosis of the jaw; monitoring for hypocalcaemia.
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We have received reports of Colobreathe (colistimethate sodium) capsules shattering when pierced by their inhaler device.
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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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Latest evidence suggests long-term use of combined oral contraceptives or progestogen-only injectable contraceptives is associated with a small increased risk of cervical cancer.
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Febuxostat must be stopped immediately if hypersensitivity occurs and must not be re-started in patients who have ever developed a hypersensitivity reaction to febuxostat.
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Risk minimisation materials are available to support the safe use of new paediatric formulations of rivaroxaban (Xarelto) and dabigatran etexilate (Pradaxa). In addition, we ask healthcare professionals to consult the curren…
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Risk of aseptic peritonitis with Dianeal, Extraneal, and Nutrineal peritoneal dialysis solutions due to possible presence of endotoxin.
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Differences in dose delivery between the pump device and dropper device for memantine.
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Capillary leak syndrome (CLS) has been reported in recipients of filgrastim, including patients undergoing chemotherapy and a healthy donor undergoing peripheral blood progenitor-cell mobilisation; it has also been reported …
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The Commission on Human Medicines (CHM) has endorsed changes to isotretinoin prescribing guidance. In addition, CHM is seeking further information from dermatology services who prescribe isotretinoin to inform any future cha…
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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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Amended advice on the insertion site for Nexplanon contraceptive implants following concerns regarding reports of neurovascular injury and implants migrating to the vasculature (including the pulmonary artery).
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High intravenous doses of methylthioninium chloride (methylene blue) should be avoided for patients being treated with serotonergic antidepressants (eg, SSRIs, clomipramine, and venlafaxine).
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Test for raised ketones in patients with ketoacidosis symptoms, even if plasma glucose levels are near-normal.
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Before initiating systemic vascular endothelial growth factor (VEGF) pathway inhibitors, carefully consider the risk of aneurysm and artery dissection in patients with risk factors. In patients who receive a systemic VEGF pa…
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The indication for the treatment of post-operative pain has been removed from the licences of all prolonged release opioids due to the increased risk of persistent post-operative opioid use (PPOU) and opioid-induced ventilat…
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A recent Europe-wide review of the safety information for alli has led to a number of updates, which bring the product information in line with that for Xenical.
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Prescribers should remain vigilant with regards to the similarity of these 2 drug names.
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All patients with cancer should have a dental check-up before bisphosphonate treatment.
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Patients taking warfarin should not use over-the-counter miconazole oral gel (Daktarin). If you plan to prescribe miconazole oral gel in a patient on warfarin, you should closely monitor them and advise that if they experien…
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Healthcare professionals should be aware of the updated information so they can discuss it with new and existing patients.
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Discontinue baricitinib treatment permanently if clinical features of deep vein thrombosis or pulmonary embolism occur. Prescribers are reminded to use caution if using baricitinib in patients with risk factors for deep vein…
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Advise patients and their caregivers to seek urgent medical attention if any signs or symptoms of communicating hydrocephalus develop during nusinersen therapy for spinal muscular atrophy. Patients with communicating hydroce…
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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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Proton pump inhibitors (PPIs) are associated with very infrequent cases of subacute cutaneous lupus erythematosus (SCLE), a non-scarring dermatosis that can develop in sun-exposed areas.
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Cases of severe hypersensitivity syndromes, sometimes fatal, have been reported with etravirine.
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The Food and Drug Administration (FDA) has received 35 reports of chondrolysis involving patients given continuous intra-articular infusions of local anaesthetics.
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Rivaroxaban treatment in patients who undergo transcatheter aortic valve replacement (TAVR) should be stopped and switched to standard of care.
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Patients on nivolumab 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 infection…
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Risk of extrapyramidal effects or withdrawal symptoms (or both) in newborns after maternal use of antipsychotics during the third trimester of pregnancy.
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Osteonecrosis of the external auditory canal has been reported very rarely (fewer than 1 in 10 000 patients) with bisphosphonates, mainly in association with long-term therapy (2 years or longer).
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N-acetylcysteine may interfere with assays from Siemens ADVIA Chemistry and Dimension/Dimension Vista instruments, leading to false-low biochemistry test results.
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Coadministration of a corticosteroid with an HIV-treatment-boosting agent may increase the risk of adrenal suppression due to a pharmacokinetic interaction.
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A reminder for those who use topical ketoprofen to avoid direct sunlight, ultraviolet rays, sunbeds or sunlamps.
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Recall will begin in September 2011 to allow sufficient time for patients to be switched to suitable alternatives.
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Basiliximab (Simulect) is indicated for preventing acute organ rejection only for allogeneic renal transplantation in patients receiving organ transplantation for the first time.
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A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices, and a recent National Patient Safety Alert asking organisations to put a plan in place to implement new regu…
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Healthcare professionals should report any suspected adverse effects relating to fingolimod (Gilenya▼) or other treatments for multiple sclerosis, including suspected adverse effects occurring after discontinuation, via the Yellow Card Scheme.
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We have initiated a new safety review into topiramate as a result of an observational study reporting an increased risk of neurodevelopmental disabilities in children whose mothers took topiramate during pregnancy.
Topir…
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Possible illicit drug use should be considered when prescribing medicines that have the potential to interact adversely.
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Screening for hepatitis B virus is now recommended in all patients (not only those at risk of this infection) before starting treatment for all indications.
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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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We have launched a public consultation on the proposal to reclassify codeine linctus to a prescription-only medicine.
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We inform healthcare professionals of the recent campaign to promote awareness of the risk and new resources available to support safe use following previous advice to health and care professionals.
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If bilirubin and/or creatinine test results are inconsistent with clinical observations, request re-testing using another method to determine the validity of the result.
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The use of daclizumab (daclizumab beta) is now restricted to adults with relapsing multiple sclerosis who have had an inadequate response to at least 2 other disease-modifying therapies (DMTs) and for whom other DMTs are con…
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The immunomodulatory effects of fingolimod increase the risk of progressive multifocal leukoencephalopathy and opportunistic infections.