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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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Abacavir should be used in line with current treatment guidelines and with caution in patients with high cardiovascular risk factors.
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A summary of recent letters, medicine recalls and notifications sent to healthcare professionals
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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 changes to current risk minimisation measures.
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A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices.
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Contact patients currently taking Esmya for uterine fibroids as soon as possible and advise them to stop their treatment. The licence for Esmya has been suspended to protect public health while a safety review is conducted f…
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In light of the most recent evidence, the previous advice on the concomitant use of clopidogrel with proton pump inhibitors has now been modified. Use of either omeprazole or esomeprazole with clopidogrel should be discourag…
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Advice for healthcare professionals regarding the withdrawal of pholcodine-containing medicines from the market.
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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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There have been a small number of reports of serious and life-threatening anticholinergic side effects associated with hyoscine hydrobromide patches, particularly when used outside the licence. Healthcare professionals, pati…
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Evaluate a patient’s individual factors for benefits and risks before initiating treatment with denosumab 60mg, particularly in those with previous vertebral fracture. Patients should not stop denosumab without specialist re…
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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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Important to inquire if patients are taking herbal medicines.
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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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It is recommended that 2 adrenaline auto-injectors are prescribed, which patients should carry at all times.
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Healthcare professionals prescribing montelukast should be alert to the risk of neuropsychiatric reactions in all patients including children and adolescents. Reported neuropsychiatric reactions include sleep disorders, hall…
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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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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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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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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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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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A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices, and information about the publication of two recent Device Safety Information pages. The article also includ…
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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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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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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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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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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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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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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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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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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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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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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 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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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 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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Advice for healthcare professionals on the reclassification of codeine linctus to a prescription-only medicine (POM), following a public consultation.
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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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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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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 …