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Carbimazole is associated with an increased risk of congenital malformations, especially when administered in the first trimester of pregnancy and at high doses. Women of childbearing potential should use effective contracep…
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Disabling, long-lasting or potentially irreversible adverse reactions affecting musculoskeletal and nervous systems have been reported very rarely with fluoroquinolone antibiotics. Fluoroquinolone treatment should be discont…
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Benzodiazepines and opioids can both cause respiratory depression, which can be fatal if not recognised in time. Only prescribe together if there is no alternative and closely monitor patients for signs of respiratory depres…
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A patient alert card is being introduced for men taking finasteride to help raise awareness of the risk of psychiatric side effects and sexual dysfunction, including the potential for sexual dysfunction to persist after trea…
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SGLT2 inhibitor treatment should be interrupted in patients who are hospitalised for major surgical procedures or acute serious medical illnesses and ketone levels measured, preferably in blood rather than urine. Treatment m…
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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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Clinical trials, including interim findings from a randomised trial, show an increased risk of depression, suicidal ideation or behaviour, or self-injury in patients with systemic lupus erythematosus receiving belimumab comp…
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We are running a social media campaign to promote the reporting of suspected adverse drug reactions to the Yellow Card Scheme in support of an awareness week from 7 to 11 November 2016. The main message of the campaign is that reporting helps make medicines safer and saves lives.…
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Updated safety recommendations have been issued as part of the European review evaluating cases of neural tube defects in babies born to mothers who became pregnant while taking the HIV medicine dolutegravir. Evidence collec…
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Healthcare professionals prescribing aripiprazole are reminded to be alert to the risk of addictive gambling and other impulse control disorders. Healthcare professionals should advise patients, their families and friends to…
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In patients at risk for aortic aneurysm and dissection, fluoroquinolones should only be used after careful assessment of the benefits and risks and after consideration of other therapeutic options.
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For most patients and most medicines, estimated Glomerular Filtration Rate (eGFR) is an appropriate measure of renal function for determining dosage adjustments in renal impairment; however, in some circumstances, the Cockcr…
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Increase the frequency of blood pressure monitoring to at least weekly for the first 2 months, and then monitor monthly for the first year and periodically thereafter during treatment, following recent reports of onset of se…
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Diabetic ketoacidosis has been reported in patients with type 2 diabetes on a combination of a GLP-1 receptor agonist and insulin who had doses of concomitant insulin rapidly reduced or discontinued. GLP-1 receptor agonists …
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Support this initiative to explore whether there is a genetic basis of side effects associated with direct-acting oral anticoagulants (DOACs) and allopurinol.
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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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Monitoring blood concentrations of clozapine (Clozaril, Denzapine, Zaponex) for toxicity is now advised in certain clinical situations. Blood level monitoring of other antipsychotics for toxicity may also be helpful in certa…
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Tapentadol may increase seizure risk in patients taking other medicines that lower seizure threshold, for example, antidepressants and antipsychotics. Serotonin syndrome has also been reported when tapentadol is used in comb…
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The medicines used to treat vitamin B12 deficiency (hydroxocobalamin, cyanocobalamin) contain cobalt. There are case reports in the literature describing cobalt sensitivity-type reactions in patients being treated for vitami…
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Falsified, potentially harmful Ozempic▼ and Saxenda products have been found in the UK.
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We are launching a pilot scheme for healthcare professionals in the UK to report suspected adverse reactions to illicit drugs, particularly new psychoactive substances.
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Administration of parenteral nutrition without a filter has been associated with a number of adverse incidents including an embolism which resulted in a fatal outcome.
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Photosensitivity reactions are known side effects of methotrexate treatment and can be severe. Patients should be advised to take precautions to protect their skin in the sun.
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Risk of insufficient cortisol absorption and life-threatening adrenal crisis if muco-adhesive buccal tablets are used as adrenal replacement therapy.
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Anti-cancer therapy with carfilzomib has been associated with cases of cardiac arrest, cardiac failure, and myocardial infarction, including in patients without pre-existing cardiac disorders. Monitor patients for signs and …
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Establish hepatitis B virus status before initiating daratumumab and in patients with unknown hepatitis B virus serology who are already being treated with daratumumab.
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Use the Yellow Card Reporting Scheme to support the safety of e-cigarettes and refill containers (e-liquids).
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Flucytosine is a prodrug of 5-fluorouracil used to treat systemic yeast and fungal infections and can cause life-threatening and severe toxicity in patients with complete and partial dihydropyrimidine dehydrogenase (DPD) def…
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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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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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Avoid treatment with febuxostat in patients with pre-existing major cardiovascular disease (for example, myocardial infarction, stroke, or unstable angina), unless no other therapy options are appropriate. Findings from a ph…
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The ANNOUNCE study failed to show clinical efficacy for olaratumab in its current indication of advanced soft tissue sarcoma and the benefit risk balance is therefore now considered negative. No new patients should be starte…
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Fezolinetant treatment is associated with a risk of drug induced liver injury. New recommendations have been introduced to minimise this risk. Liver function should be monitored before and during treatment in all patients ta…
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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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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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Provide clear information to patients and caregivers about how to minimise the risk of accidental exposure and the importance of appropriate disposal of patches. We continue to receive reports of unintentional opioid toxicit…
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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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Taking warfarin and tramadol together can cause harmful drug interactions, which can raise the International Normalised Ratio (INR), and result in severe bruising and bleeding, which in some patients could be fatal.
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Maternal administration of magnesium sulfate for longer than 5–7 days in pregnancy has been associated with skeletal adverse effects and hypocalcaemia and hypermagnesemia in neonates. If use of magnesium sulfate in pregnancy…
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The product information has been updated for all domperidone products, to include a contraindication for patients with confirmed or suspected phaeochromocytoma (a rare tumour of the adrenal gland), due to the risk of episode…
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Gabapentin has been associated with a rare risk of severe respiratory depression even without concomitant opioid medicines. Patients with compromised respiratory function, respiratory or neurological disease, renal impairmen…
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Monitor glucose levels closely in patients with diabetes during direct-acting antiviral therapy for hepatitis C, particularly within the first 3 months of treatment, and modify diabetes medication or doses when necessary. Pa…
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Make a clear distinction between liposomal, pegylated-liposomal, lipid-complex and conventional formulations when prescribing, dispensing, administering, and communicating about these medicines. Medicines with these formulat…
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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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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 safety review has been conducted by the MHRA following a Yellow Card report concerning a patient who was taking bromocriptine. The review concluded that blood pressure monitoring of patients prescribed with this drug is essential especially during the first days of treatment.
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Addition of a polyethylene glycol (PEG)-based laxative to a liquid that has been thickened with a starch-based thickener may counteract the thickening action, placing patients with dysphagia at a greater risk of aspiration.
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Establish hepatitis B status before initiating carfilzomib and in patients with unknown hepatitis B virus serology who are already being treated with carfilzomib.
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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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Monitor serum phosphate levels in patients treated with multiple high-dose administrations, or those on long-term treatment, and in those with pre-existing risk factors for hypophosphataemia. Re-evaluate ferric carboxymaltos…