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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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Falsified, potentially harmful Ozempic▼ and Saxenda products have been found in the UK.
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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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7 January 2021 - Advice from the MHRA on the COVID-19 vaccines authorised for use in the UK, including advice for people with allergies and for women during pregnancy and breastfeeding.
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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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Cases of serious liver injury with elevated transaminases and bilirubin have been reported during treatment with Kaftrio–Kalydeco combination therapy. In all patients, measure alanine aminotransferase (ALT), aspartate aminot…
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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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Use the Yellow Card Reporting Scheme to support the safety of e-cigarettes and refill containers (e-liquids).
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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The authorisation holder for dapagliflozin has withdrawn the indication for type 1 diabetes mellitus. The removal of the type 1 diabetes indication is not due to any new safety concerns and the other indications of dapaglifl…
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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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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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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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We have simplified our medicine and device incident report systems by bringing them all under the Yellow Card Scheme.
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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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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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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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Recent information relating to COVID-19 vaccines and medicines that has been published since the March 2022 issue of Drug Safety Update, up to 14 April 2022.
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Premature puberty and genital enlargement have been reported in children who were in close physical contact with an adult using topical testosterone and who were repeatedly accidentally exposed to this medicine. To reduce th…
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Recent information relating to COVID-19 vaccines and medicines that has been published since the December 2022 issue of Drug Safety Update, up to 23 January 2022.
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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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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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Rarely, severe adverse effects can occur on stopping treatment with topical corticosteroids, often after long-term continuous or inappropriate use of moderate to high potency products. To reduce the risks of these events, pr…
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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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Liver monitoring requirements and discontinuation criteria for fingolimod have been updated following reports of serious liver injury. Fatal cases of encephalitis and meningitis caused by herpes simplex and varicella zoster …
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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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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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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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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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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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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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The paediatric indication for chloral hydrate (for children aged 2 years and older) and cloral (previously chloral) betaine (children aged 12 years and older) has been restricted to short-term treatment (maximum 2 weeks) of …
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MHRA continues to identify cases of herbal medicines, particularly traditional Chinese medicines, which contain illegal and toxic Aristolochia or aristolochic acids.
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Recent information relating to COVID-19 vaccines and medicines that has been published since the December 2021 issue of Drug Safety Update, up to 13 January 2022.
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Recent information relating to COVID-19 vaccines and medicines that has been published since the January 2023 issue of Drug Safety Update, up to 21 February 2023.
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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.…
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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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Serious and life-threatening hypercalcaemia has been reported with denosumab 60mg (Prolia) in children and adolescents in clinical trials for osteogenesis imperfecta and during off-label use. Denosumab 60mg (Prolia) is autho…
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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…
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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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Healthcare professionals prescribing fluoroquinolone antibiotics (ciprofloxacin, delafloxacin, levofloxacin, moxifloxacin, ofloxacin) are reminded to be alert to the risk of psychiatric reactions, including depression and ps…
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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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Recent epidemiological studies suggest exposure to ondansetron during the first trimester of pregnancy is associated with a small increased risk of the baby having a cleft lip and/or cleft palate.
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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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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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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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The monitoring requirements and discontinuation criteria for dimethyl fumarate (Tecfidera) have been strengthened following a small number of reports of progressive multifocal leukoencephalopathy (PML) in patients with mild …