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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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The seventh annual #MedSafetyWeek social media campaign will take place 7 to 13 November 2022 and this year’s focus is the importance of reporting suspected adverse reactions to medicines and vaccines. We are also encouragin…
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Healthcare professionals should warn patients that compulsive behaviour with dopamine agonists may be dose-related.
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Healthcare professionals reminded that tacrolimus may be associated with possible risk of malignancy.
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Alerts were issued about T34 ambulatory syringe pumps, Gripper needles, and 1-day Acuvue Moist for astigmatism contact lenses.
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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. We ask healthcare professionals to review…
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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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A summary of recent letters, medicine recalls and notifications sent to healthcare professionals
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Tazocin (piperacillin/tazobactam) has been reformulated to meet European Pharmacopoeia requirements on particle size.
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New recommendations following a review of the risks of dependence and addiction associated with prolonged use of opioid medicines (opioids) for non-cancer pain. Before prescribing opioids, discuss with the patient the risks …
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In December 2018, a letter was sent to notify healthcare professionals of the discontinuation of Zovirax (Aciclovir) eye ointment. We also highlight the recent recall of Actavis batches of irbesartan/hydrochlorothiazide tabl…
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Alerts issued include important actions for enFlow IV fluid and blood warmers due to a risk of unsafe levels of aluminium leaching from the device. Other alerts were issued on implantable cardiac pacemakers, Accu-Chek Insigh…
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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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More than one treatment course is authorised only in women who are not eligible for surgery, and liver function monitoring is to be carried out in all women treated with Esmya. Before initiation, discuss with women the rare …
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If an adverse drug reaction is suspected, ask patients if they are taking any herbal or homeopathic medicines and report any suspicions to the Yellow Card scheme. Remind patients to check that a herbal or homeopathic medicin…
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Guidance has been published to support initiation of valproate in female patients and for annual review and pregnancy testing during the coronavirus pandemic.
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Risks such as toxin spread reported mostly with off-label use.
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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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Risk of meningioma with cyproterone acetate increases with increasing cumulative dose. Use of cyproterone is contraindicated in patients with previous or current meningioma (for all indications) and should only be considered…
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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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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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Preliminary HPS2-THRIVE trial failed to show benefit outweighs risks
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A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices.
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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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Healthcare professionals should consider measuring magnesium levels before starting PPI treatment and repeat measurements periodically during prolonged treatment.
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Letters were sent about quadrivalent influenza vaccine, fentanyl ampoules, and Volibris (ambrisentan), and a number of pharmacy-level recalls were issued for ranitidine-containing products. Other alerts issued in October 2019 are also summarised in this article.…
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Healthcare professionals should advise patients who need re-vaccination with Pneumovax II to expect a more intense reaction than after their first vaccination.
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If an adverse reaction is suspected, ask patients whether they are taking any herbal medicines and discuss with them the importance of reporting this via the Yellow Card Scheme.
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From October 2014 Dexamethasone 4 mg/ml injection (Organon Laboratories Limited) will be replaced by Dexamethasone 3.8 mg/ml solution for injection (Aspen Pharma Trading Limited).
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All products to be named and prescribed as caffeine citrate.
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Letters were sent to healthcare professionals about Lartruvo▼ (olaratumab), quadrivalent influenza vaccine (split virion, inactivated), SGLT2 inhibitors, and carbimazole and thiamazole (synonym: methimazole)-containing products.…
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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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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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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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Any healthcare professional can submit a Yellow Card, including students. When submitting a report about a medicine via the Yellow Card website, if your occupation is not available in our drop-down list, you can now select ‘…
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Zoledronic acid is associated with reports of renal impairment and renal failure, especially in patients with pre-existing renal dysfunction or other risk factors. Renal function should be measured before each dose, and pati…
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We are no longer requesting all suspected adverse drug reactions (ADRs) to be reported for children.
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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 patients for signs of histamine-related adverse reactions.…
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The indication of ulipristal acetate 5mg for uterine fibroids has been further restricted due to the risk of serious liver injury and liver failure, with some cases requiring liver transplantation. Although the temporary sus…
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Updated advice on use of nicorandil as second-line treatment for stable angina - some ulcers may progress to complications unless treatment is stopped.
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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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Liver function tests should be carried out at treatment initiation, during treatment, and also when the dose is increased.
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A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices.
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Liver function should be tested before and during treatment with temozolomide.
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Letters were sent about ranibizumab and Emerade adrenaline auto-injectors. Alerts were issued about ranitidine, paracetamol, omeprazole, mitomycin-C Kyowa, folic acid, and Emerade adrenaline auto-injectors.
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Clinical trials have reported an increased risk of renal dysfunction and mortality in critically ill or septic patients who received hydroxyethyl starch (HES) compared with crystalloids.
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There is an increased risk of myopathy associated with high-dose (80 mg) simvastatin. The 80-mg dose should be considered only in patients with severe hypercholesterolaemia and high risk of cardiovascular complications who h…
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If Fournier’s gangrene is suspected, stop the SGLT2 inhibitor and start treatment urgently (including antibiotics and surgical debridement). Fournier’s gangrene is a rare but potentially life-threatening infection that requi…
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Safety studies of Spiriva Respimat▼
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A summary of letters and drug alerts recently sent to healthcare professionals.