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Review by two specialists remains in place for patients initiating valproate under 55 years of age but the Commission on Human Medicines (CHM) has advised that it will not be required for men (or males) currently taking valp…
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…MHRA issued alerts and recalls for valsartan-containing medicines, Fiasp FlexTouch pre-filled pens, melatonin capsules, and sodium cromoglicate eye drops.
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…The product information for all Glucagon-Like Peptide-1 (GLP-1) receptor agonists and dual GLP-1/glucose-dependent insulinotropic polypeptide (GIP) receptor agonists has been further updated to highlight the potential risk of severe acute pancreatitis with these products, including rare…
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We are providing an update on a retrospective observational study on the risk to children born to men who took valproate in the 3 months before conception and on the need for the re-analysis of the data from this study befor…
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Cases of pigmentary maculopathy leading to visual impairment have been reported with pentosan polysulfate, particularly after long-term use at high doses. Ensure patients taking pentosan polysulfate have regular ophthalmic e…
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A summary of letters and drug alerts recently sent to healthcare professionals.
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Reminder to monitor and manage weight, glucose, and lipid levels.…
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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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Clinical trial results suggest an increased risk of atrial fibrillation for zoledronic acid (Aclasta▼), pamidronic acid, and possibly for alendronic acid, although the balance-risk remains favourable for bisphosphonates.
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…Renal function monitoring is recommended after use of zoledronic acid in at-risk patients—especially those with pre-existing renal impairment.…
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…The use of gadobenic acid (also known as gadobenate dimeglumine; MultiHance) and gadoxetic acid (Primovist) will be limited to delayed phase liver imaging only*.…
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To avoid the risk of air embolism, these products should not be infused under pressure.
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In view of data showing ongoing exposure to valproate in pregnancy, this article reminds healthcare professionals of the risks in pregnancy and the current Pregnancy Prevention Programme requirements, and provides informatio…
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We are aware of reports of serious liver injuries and deaths in patients with primary biliary cholangitis with pre-existing moderate or severe liver impairment who were not adequately dose-adjusted. Follow dose reduction and…
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Systematic reviews and meta-analyses of randomised controlled trials have highlighted a dose-dependent increased risk of atrial fibrillation in patients with established cardiovascular diseases or cardiovascular risk factors treated with omega-3-acid ethyl ester medicines compared to placebo…
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A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices.
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Omniscan and intravenous Magnevist are now no longer authorised for use and a product recall of any existing unexpired stock is underway.
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We have received reports of Colobreathe (colistimethate sodium) capsules shattering when pierced by their inhaler device.
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…Cholestasis of pregnancy associated with thiopurines tends to occur earlier in pregnancy than non drug-induced cholestasis of pregnancy, and elevated bile acid levels may not reduce with ursodeoxycholic acid.…
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A large study has shown no safety issues of concern relating to the use of metformin during pregnancy. The licence for metformin now reflects that it can be considered for use during pregnancy and the periconceptional phase …
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A retrospective observational study has indicated a possible association between valproate use by men around the time of conception and an increased risk of neurodevelopmental disorders in their children.
Inform male p…
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A summary of letters sent to relevant healthcare professionals in December 2016.
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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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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 drops containing borax or boric acid remains positive for children…
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Letters were sent about Oncaspar▼ (pegaspargase), Ketalar (ketamine) injection, and Elmiron (pentosan polysulfate sodium).…
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liver-function testing recommended in patients with symptoms that may indicate liver injury.
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Gadolinium-containing contrast agents are associated with a varying degree of risk of nephrogenic systemic fibrosis. See advice below to minimise risk in the following vulnerable groups: patients with renal impairment; patie…
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May cause skin irritation, particularly in children with eczema, possibly due to sodium lauryl sulfate content.
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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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Letters were sent about insulin Fiasp and Tresiba and Inhixa (enoxaparin sodium); use survey to feedback your thoughts on Direct Healthcare Professional Communications (DHPCs) and on the way medicines safety issues are communicated.
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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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Rivaroxaban treatment in patients who undergo transcatheter aortic valve replacement (TAVR) should be stopped and switched to standard of care.
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Mycophenolate mofetil and its active metabolite mycophenolic acid, both used to prevent transplant rejection, are teratogenic and genotoxic.…
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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 prevention of skeletal-related events with advanced malignancies involving…
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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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We have issued a National Patient Safety Alert following serious reports of harm associated with insulin leakage during use of the Accu-Chek Insight Insulin pump with NovoRapid PumpCart prefilled insulin cartridges. Patients…
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A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices. Includes a recent recall of Accupro (quinapril hydrochloride) and advice on Xagrid (anagrelide hydrochloride…
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A summary of letters and drug alerts recently sent to healthcare professionals, including recommendations to reduce handling errors with leuprorelin-containing depot medicines.
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With the exception of medicines containing zidovudine, stavudine, or didanosine, product information will no longer include warnings on fat redistribution or lactic acidosis.
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A summary of recent letters and notifications sent to healthcare professionals about medicines.
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Healthcare professionals should be aware of the potential risk of pulmonary aspiration in patients using GLP-1 or dual GIP/GLP-1 receptor agonists who undergo surgery or procedures with general anaesthesia or deep sedation.
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A summary of letters and recent medicine recalls and notifications sent to healthcare professionals.
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Check full blood counts before prescribing dimethyl fumarate and then every 6 to 12 months. Stop treatment immediately if you suspect progressive multifocal leukoencephalopathy.
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MHRA continues to identify cases of herbal medicines, particularly traditional Chinese medicines, which contain illegal and toxic Aristolochia or aristolochic acids.
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…As a result, it can only be diluted with either dextrose 5% solution or sodium chloride 0·9% solution
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Recent MHRA National Patient Safety Alerts to remove from service Philips Health Systems V60 and V60 Plus ventilators and to recall Emerade adrenaline auto-injectors from patients, pharmacies and wholesalers. We also provide…
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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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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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A clinical trial has shown an increased risk of recurrent thrombotic events associated with rivaroxaban compared with warfarin, in patients with antiphospholipid syndrome and a history of thrombosis. Other direct-acting oral…
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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.