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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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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 summary of advice recently issued by the MHRA relating to coronavirus (COVID-19), up to 11 June 2021.
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Prescribers should be aware of the risk of potentiation of radiation toxicity with vemurafenib when given before, during, or after radiotherapy
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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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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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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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Oral lidocaine-containing products for infant teething are only to be available under the supervision of a pharmacist so that parents and caregivers can receive guidance about managing infant teething symptoms. Non-medicinal…
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Healthcare professionals and patients are reminded of the risk of severe asthma attacks and increased mortality associated with overuse of SABA with or without anti-inflammatory maintenance therapy in patients with asthma. H…
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Recent information relating to COVID-19 vaccines and medicines that has been published since the February 2023 issue of Drug Safety Update, up to 21 March 2023.
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Guidance has been published on monitoring of patients on warfarin and other anticoagulants during the COVID-19 pandemic.
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We have strengthened the safe use of isotretinoin through the introduction of additional oversight of the initiation of isotretinoin in patients under 18 years and through improved assessment and monitoring of mental health …
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No unexpected new safety issues have been identified from Yellow Card reports.
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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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Serious liver injury has been reported during treatment with pirfenidone in the first year after initiation, including 2 cases with a fatal outcome. Measure alanine aminotransferase (ALT), aspartate aminotransferase (AST), a…
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Remind patients to check and remove the mouthpiece cover properly before inhaling a dose and to shake the inhaler to remove loose objects that may have become trapped in the inhaler during storage. The mouthpiece cover shoul…
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Pharmacokinetic data indicate exposure of elvitegravir boosted with cobicistat (Genvoya▼, Stribild) is lower during the second and third trimesters of pregnancy than postpartum. Low elvitegravir exposure may be associated wi…
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New pharmacokinetic data show mean exposure of darunavir (brand name Prezista) boosted with cobicistat (available in combination in Rezolsta▼, Symtuza▼) to be lower during the second and third trimesters of pregnancy than du…
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Onivyde has been associated with reports of serious thromboembolic events, such as pulmonary embolism, venous thrombosis, and arterial thromboembolism.
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In view of reports of serious bleeding events in patients taking miconazole and warfarin, we are considering further measures to minimise the risk of potentially serious interactions between miconazole and warfarin.
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Risk of serious side effects on fertility, the liver, kidneys, immune system, blood, and heart.
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New safety recommendations have been issued while an EU review evaluates cases of neural tube defects in babies born to mothers who became pregnant while taking the HIV medicine dolutegravir.
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Cases of sexual dysfunction, predominantly involving erectile dysfunction and decreased libido, have been reported rarely in patients taking oral isotretinoin for severe acne.
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Spontaneous reporting on the Yellow Card portal has provided important information in the identification of PML associated with some drugs.
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Test liver function before and during treatment and tell patients to avoid sunlight exposure.
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There have been reports of cardiac events including QT prolongation, torsades de pointes, and cardiac arrest in patients who have taken high or very high doses of loperamide as a drug of abuse or for self-treatment of opioid…
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Cases of benign and malignant neoplasms have been observed among children and adolescents who received treatment with mecasermin. Do not use mecasermin in children or adolescents with active or suspected neoplasia or with an…
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New safety and educational materials have been introduced for men and women and healthcare professionals to reduce the harms from valproate, including the significant risk of serious harm to the baby if taken during pregnanc…
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Monitor patients for signs and symptoms of hypercalcaemia after discontinuation of denosumab treatment for giant cell tumour of bone. Cases of rebound hypercalcemia have been reported up to 9 months after cessation of treatm…
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Healthcare professionals should monitor the use and safety of antiretroviral drugs for the treatment of HIV as they are advanced.
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Insufficient evidence to confirm a link between oral bisphosphonate use and an increased risk of oesophageal cancer.
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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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Previously co-dydramol (dihydrocodeine/paracetamol) was available only in the ratio 1:50 (co-dydramol 10/500 mg). Two products are now available with a higher strength of dihydrocodeine (co-dydramol 20/500 mg and 30/500 mg t…
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There is no known interaction between oseltamivir and aspirin but aspirin must not be given to anyone younger than 16 year.
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Use of a nebuliser purchased independently of medical advice for use in the home to deliver nebulised asthma rescue medications to children can mask a deterioration in the underlying disease and may increase the risk of pote…
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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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Following the completion of a safety review and the recommendations of the Commission on Human Medicines (CHM), the IXCHIQ Chikungunya vaccine is no longer indicated for adults over the age of 60 years, and is contraindicate…
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New prescriber checklists, patient reminder cards, and pharmacy checklists are available to support the Pregnancy Prevention Programme in women taking acitretin, alitretinoin, and isotretinoin. Advice about the risk of neuro…
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A European review has considered MHRA evidence together with additional information from spontaneous reporting and published literature.
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Interrupt treatment if posterior reversible encephalopathy syndrome (PRES) is confirmed and resume treatment only once the event is resolved and the benefit of continued treatment outweighs the risk of PRES.
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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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Letters were issued about parenteral nutrition products, ranibizumab, ingenol mebutate gel, adrenaline auto-injectors, and fingolimod. Recall alerts were recently issued about ranitidine, aripiprazole, and bisacodyl.
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…If thin, translucent or white-to-yellow proteinaceous strands (1–2 mm in length) are visible, filtration is advised.
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Tofacitinib should not be used in patients older than 65 years of age, people who are current or past smokers, or individuals with other cardiovascular (such as diabetes or coronary artery disease) or malignancy risk factors…
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St John’s wort interacts with hormonal contraceptives reducing the effectiveness and increasing the risk of unplanned pregnancy.
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Systemic cardiovascular effects including bradycardia, hypotension, and dizziness have been reported after application. It is important to avoid application to irritated or damaged skin, including after laser therapy.
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Patients with epilepsy should not take products that contain St John’s wort as any antiepileptic medicine may interact with St John’s wort.
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If you suspect exfoliative dermatitis caused by an adverse drug reaction to ustekinumab, stop treatment.
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There is an increased risk that some patients may experience psychiatric symptoms with apremilast, including depression and suicidal thoughts. Stop treatment if patients have new psychiatric symptoms or if existing symptoms …
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The Commission on Human Medicines (CHM) has temporarily restricted use of the IXCHIQ Chikungunya vaccine in people aged 65 years and over following very rare fatal reactions reported globally. This is a precautionary measure…