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Recent information relating to COVID-19 vaccines and medicines that has been published since the January 2022 issue of Drug Safety Update, up to 11 February 2022.
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We ask healthcare professionals to be vigilant to adverse incidents involving software, apps, and artificial intelligence (AI) as medical devices and to report incidents to us via the Yellow Card scheme.
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Key MHRA advice and guidance issued so far on medicines safety and pharmacovigilance, including on reporting to the Yellow Card Scheme.…
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The human papillomavirus (HPV) immunisation programme is now entering its second year and this article summarises the safety experience to date.
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If an adverse drug reaction is suspected, ask patients if they are taking any herbal or homeopathic medicines and report any suspicions to the Yellow Card scheme.…
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A reminder to healthcare professionals to fill out Yellow Card reports.
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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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We have published guidance about the use of remote consultations for pregnancy prevention in women of childbearing potential and monitoring for signs of psychiatric reactions (especially depression) and other safety risks in…
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Information on the newly launched Safer Medicines in Pregnancy and Breastfeeding Consortium and a new report on optimising data on medicines used during pregnancy.
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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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Reporting to the new site will enable the MHRA to rapidly identify new and emerging side effects and medical device incidents in COVID-19 treatment, including side effects for medicines taken by patients to manage long-term …
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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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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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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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Second year safety review
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Recent information relating to COVID-19 vaccines and medicines that has been published since the October 2022 issue of Drug Safety Update, up to 24 November 2022.
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Albumin-bound paclitaxel formulations for infusion (nab-paclitaxel; brand names Abraxane, Pazenir) differ from conventional paclitaxel medicines in their authorised indications, pharmacokinetics, recommended dosages, and pre…
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Recent information relating to COVID-19 vaccines and medicines that has been published since the May 2022 issue of Drug Safety Update, up to 17 June 2022.
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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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The third-line treatment indication for rucaparib has been withdrawn following a review of the findings of the ARIEL-4 trial, which showed lower overall survival for rucaparib treatment versus standard chemotherapy in patien…
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We remind healthcare professionals that elderly patients are at an increased risk of adverse neurological and cardiac effects when being treated with haloperidol for delirium. The lowest possible dose of haloperidol should b…
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Recent information relating to COVID-19 vaccines and medicines that has been published since the October 2021 issue of Drug Safety Update, up to 12 November 2021.
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Reporting suspected adverse drug reactions to the Yellow Card Scheme helps to support the safe use of medicines in babies, children, and pregnant and breastfeeding women.…
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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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Recent information relating to COVID-19 vaccines and medicines that has been published since the July 2022 issue of Drug Safety Update, up to 19 August 2022.
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Monitor thyroid-stimulating hormone (TSH) in patients treated with levothyroxine for at least the first month after starting and ending ritonavir treatment.
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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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Recent information relating to COVID-19 vaccines and medicines that has been published since the November 2021 issue of Drug Safety Update, up to 3 December 2021.
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Recent information relating to COVID-19 vaccines that has been published since the July 2021 issue of Drug Safety Update.
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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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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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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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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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If a patient reports persistent symptoms when switching between different levothyroxine tablet formulations, consider consistently prescribing a specific product known to be well tolerated by the patient. If symptoms or poor…
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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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Falsified, potentially harmful Ozempic▼ and Saxenda products have been found in the UK.
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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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We are running a second social media campaign to promote the reporting of suspected adverse drug reactions (ADRs) to the Yellow Card Scheme in support of the ADR awareness week taking place 20-24 November 2017.…
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Healthcare professionals working in primary and secondary care should ensure that clinically significant immunosuppression in a patient is identified before administration of a live attenuated vaccine.
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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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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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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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Recent information relating to COVID-19 vaccines and medicines that has been published since the September 2022 issue of Drug Safety Update, up to 21 October 2022.
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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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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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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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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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We inform healthcare professionals that the Medicines and Healthcare products Regulatory Agency (MHRA) has launched new guidance to highlight the latest safety advice on the steps to take during anaphylaxis. This new guidanc…
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Recent information relating to COVID-19 vaccines and medicines that has been published since the February 2022 issue of Drug Safety Update, up to 11 March 2022
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Report to the Yellow Card Scheme suspected adverse reactions associated with medicines taken during pregnancy experienced by women or the baby or child.…