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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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Systemic fluoroquinolones must now only be prescribed when other commonly recommended antibiotics are inappropriate. This follows a review by the MHRA which looked at the effectiveness of current measures to reduce the ident…
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There have been very rare reports of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) with pseudoephedrine.
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We remind healthcare professionals that isotretinoin should only be used for severe forms of acne resistant to adequate courses of standard therapy with systemic antibacterials and topical therapy. Prescription of isotretino…
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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 o…
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The annual #MedSafetyWeek campaign takes place from 3 to 9 November 2025. This year’s campaign theme is ‘we can all help make medicines safer.’
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Important to inquire if patients are taking herbal medicines.
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Revisions have been made to the information for healthcare professionals and information for UK vaccine recipients for the COVID-19 Vaccine Moderna and Pfizer/BioNTech COVID-19 vaccine following a thorough review of extremel…
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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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Amiodarone has been associated with serious and potentially life-threatening side effects, particularly of the lung, liver, and thyroid gland. We remind healthcare professionals that patients should be supervised and reviewe…
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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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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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Healthcare professionals prescribing nitrofurantoin should be alert to the risks of pulmonary and hepatic adverse drug reactions and advise patients to be vigilant for the signs and symptoms in need of further investigation.
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Risk of serious skin-related adverse drug reactions, including Stevens-Johnson syndrome, occurring with carbamazepine may be increased in the presence of the HLA-A*3101 allele in patients of European descent or Japanese orig…
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A summary of recent letters, medicine recalls and notifications sent to healthcare professionals
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A standardised pre-vaccination checklist has been introduced to ensure the yellow fever vaccine is indicated for the intended travel destination and to enable vaccinators to identify existing contraindications or precautions…
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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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We have recently received 2 reports of fatal adverse reactions to the yellow fever vaccine (Stamaril). Due to an increased risk of life-threatening reactions, the vaccine must not be given to anyone with a medical history of…
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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…
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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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Healthcare professionals prescribing fluoroquinolone antibiotics (ciprofloxacin, delafloxacin, levofloxacin, moxifloxacin, ofloxacin) are reminded to be alert to the risk of disabling and potentially long-lasting or irrevers…
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Non-arteritic anterior ischemic optic neuropathy (NAION), a condition that can cause sudden deterioration in vision, usually in one eye at a time, has been very rarely reported in association with semaglutide in the treatmen…
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Cases of interstitial lung disease and pneumonitis have been reported in patients receiving CDK4/6 inhibitors indicated for some breast cancers. Ensure that patients taking these medicines are aware of the need to seek advic…
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Evidence suggests an increased risk of aminoglycoside-associated ototoxicity in patients with mitochondrial mutations, including cases in which the patient’s aminoglycoside serum levels were within the recommended range. The…
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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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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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Prescribers and dispensers should use caution if switching patients between different long-acting formulations of methylphenidate (Concerta XL, Medikinet XL, Equasym XL, Ritalin LA, and generics) as different instructions fo…
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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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We have introduced pack size restrictions, revised recommended ages for use, and new safety warnings for over-the-counter stimulant laxatives (orally and rectally administered) following a national safety review. Advise pati…
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There is a risk of harmful drug interactions with the ritonavir component of the COVID-19 treatment Paxlovid▼ due to its inhibition of the enzyme CYP3A, which metabolises many commonly used drugs. Prescribers should obtain a…
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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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How MHRA monitors the impact of regulatory action taken.
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Globally, there has been a very small number of reports of new-onset or aggravation of pre-existing myasthenia gravis with atorvastatin, pravastatin, lovastatin, fluvastatin, simvastatin, rosuvastatin and pitavastatin (singl…
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Healthcare professionals should be aware of alerts and letters issued about adrenaline auto-injectors in September and October 2019. This article provides a summary of recent advice issued to healthcare professionals, includ…
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We remind healthcare professionals that elderly patients are at an increased risk of adverse neurological and cardiac effects when being treated with haloperidol for delirium. The lowest possible dose of haloperidol should b…
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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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Carefully consider the benefits and risks before prescribing systemic azithromycin or other systemic macrolide antibiotics (erythromycin or clarithromycin) to patients being treated with hydroxychloroquine or chloroquine. An…
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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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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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Prescribers and dispensers should use caution if switching patients between different metolazone preparations as the rate and extent of absorption of metolazone are formulation dependent. This can impact the bioavailability …
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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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Emerade 300 and 500 microgram adrenaline auto-injectors have been re-supplied to the market following the implementation of corrective actions – patients and their caregivers should be provided with training and advice speci…
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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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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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Advice for healthcare professionals on the reclassification of codeine linctus to a prescription-only medicine (POM), following a public consultation.
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A review is being undertaken by the Medicines and Healthcare products Regulatory Agency with advice from the Commission on Human Medicines and the Isotretinoin Expert Working Group due to concerns about the possible association between isotretinoin and suspected psychiatric and sexual…
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We inform healthcare professionals of new risk minimisation measures for JAK inhibitors used to treat chronic inflammatory disorders, consistent with the measures introduced for tofacitinib (Xeljanz) in 2020 and 2021. This a…
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There have been reports of worsening nasal congestion (rebound congestion) when the effects of nasal decongestant sprays or drops containing xylometazoline hydrochloride and oxymetazoline hydrochloride, wear off.
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Topical steroid products are safe and highly effective treatments for the management of a wide range of inflammatory skin diseases but have important risks, especially with prolonged use at high potency. In the coming months…
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New recommendations following a recent clinical trial which found that in patients with type 1 hepatorenal syndrome terlipressin may cause serious or fatal respiratory failure at a frequency higher than previously known, and…