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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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Cases of severe cutaneous adverse reactions, including Stevens-Johnsons syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported in patients treated with immune-stimulatory anti-cancer drugs, including atezoli…
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Periodically perform skin examinations in patients on bendamustine-containing regimens and consider PML in the differential diagnosis for patients on bendamustine with new or worsening neurological, cognitive, or behavioural…
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False blood glucose readings when used to flush arterial lines leading to incorrect insulin administration and potentially fatal hypoglycaemia.
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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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Use a lower starting dose of thalidomide in patients with untreated multiple myeloma who are older than age 75 years.
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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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Fingolimod is associated with an increased risk of major congenital malformations including cardiac, renal, and musculoskeletal defects, when used in pregnancy. Women of childbearing potential must use effective contraceptio…
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Reports of pigment changes in ocular tissue, skin, lips or nails.
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The ninth annual #MedSafetyWeek social media campaign is taking place 4 to 10 November 2024.
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Monitor patients closely and remove the vaginal delivery system immediately in cases of excessive or prolonged uterine contractions, at the onset of labour, or if there is clinical concern for mother or baby.
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In view of data showing ongoing exposure to valproate in pregnancy, this article reminds healthcare professionals of the risks in pregnancy and the current Pregnancy Prevention Programme requirements, and provides informatio…
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Prescribing advice should be followed carefully, particularly recommended upper dose limits due to associated higher gastrointestinal risk than most other NSAIDs in the class.
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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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Healthcare professionals should monitor the use and safety of antiretroviral drugs for the treatment of HIV as they are advanced.
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Be especially alert for adverse drug reactions (ADRs) in patients taking more than one medicine and report any suspected ADRs to the Yellow Card Scheme. Show your support for the MHRA’s ADR awareness week campaign on 17–23 F…
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Extension of the indication for nicotine replacement therapy (NRT) to include harm reduction.
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Valproate medicines must not be used in women of childbearing potential unless the Pregnancy Prevention Programme is in place. If you are involved in the care of female patients on valproate in the UK, see a reminder of acti…
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Use in women who are planning pregnancy should be avoided unless absolutely necessary, in which case the potential risks and benefits should be discussed
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A UK and Europe-wide review of available efficacy and safety data confirmed that reboxetine has benefit over placebo in its authorised indication.
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Measure serum immunoglobulin levels if recurrent infections develop. Consider bronchiectasis or pulmonary fibrosis if patients develop persistent respiratory symptoms.
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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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There have been reports of thrombotic microangiopathy and nephrotic syndrome linked to interferon beta treatment.
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Indication restricted to second-line treatment and contraindicated with some cardiovascular conditions and medicines
Furthermore, cilostazol is now contraindicated in patients with any of the following:
Unstable ang…
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Saquinavir at a reduced dose for the first week of treatment
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A summary of recent letters and notifications sent to healthcare professionals about medicines.
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New warnings due to risk of hyperkalaemia, hypotension, and impaired renal function have been agreed following an EU-wide review.
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Patients on ipilimumab who present with diarrhoea or other symptoms of colitis, and those who do not respond to steroid treatment for immune-related colitis, should be investigated to exclude other causes, including infectio…
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We remind healthcare professionals that accidental use of glucose-containing solutions as flush fluid for arterial lines may contaminate blood samples and result in falsely high glucose readings. This may lead to inappropriate insulin administration and subsequent hypoglycaemia.…
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Repeat enhanced cardiovascular monitoring when restarting fingolimod after treatment interruption,
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A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices.
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A summary of letters and drug alerts recently sent to healthcare professionals.
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Take the risk of cardiovascular side effects into account when prescribing tiotropium delivered via Respimat or Handihaler to patients with certain cardiac conditions, who were excluded from clinical trials of tiotropium (in…
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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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Following a review of the risks associated with use of opioid medicines for non-cancer pain, the Commission on Human Medicines (CHM) has recommended that fentanyl transdermal patches are contraindicated in opioid-naive patie…
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Temporarily discontinue ibrutinib in patients who develop symptoms suggestive of ventricular arrhythmia and assess benefit-risk before restarting therapy. Establish hepatitis B virus status before initiating ibrutinib. Consi…
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Patients on nivolumab who present with diarrhoea or other symptoms of colitis, and those who do not respond to steroid treatment for immune-related colitis, should be investigated to exclude other causes, including infection…
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Concerns over recent years about the use of antipsychotics to treat the behavioural and psychological symptoms of dementia (BPSD).
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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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…Medicines with these formulations that have a high risk of medication error will explicitly include ‘liposomal’, ‘pegylated-liposomal’ or ‘lipid-complex’ within their name to reduce potentially fatal medication errors.…
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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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While an urgent EU-wide review of new information on liver safety is under way, promptly review patients on treatment. Only initiate daclizumab in restricted groups of patients with limited treatment options and keep all pat…
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In autoimmune conditions and some cancer therapies, methotrexate should be taken once a week; however, we continue to receive reports of inadvertent overdose due to more frequent dosing (including daily administration). New …
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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 immunomodulatory effects of fingolimod increase the risk of progressive multifocal leukoencephalopathy and opportunistic infections.
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A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices.
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Cases of serotonin syndrome have been identified in associated with bupropion, especially in overdose or when bupropion is administered with other drugs with a serotonergic effect.
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Ongoing patient survey data suggest that more effort is needed by clinicians to achieve full and timely compliance with the valproate Pregnancy Prevention Programme and meet the goal to rapidly reduce and eventually eliminat…
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Mycophenolate mofetil and its active metabolite mycophenolic acid, both used to prevent transplant rejection, are teratogenic and genotoxic. The available clinical evidence does not indicate an increased risk of malformation…