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Tofacitinib (Xeljanz▼): new measures to minimise risk of major adverse cardiovascular events and malignancies
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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Chloral hydrate, cloral betaine (Welldorm): restriction of paediatric indication
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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MedSafetyWeek November 2021: support the safety of vaccines
Our sixth annual #MedSafetyWeek social media campaign will take place on 1 to 7 November 2021. This year’s theme is on the importance of reporting suspected adverse reactions to vaccines.
Show your support by sharing MHRA …
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COVID-19 vaccines: updates for October 2021
Recent information relating to COVID-19 vaccines and medicines that has been published since the September 2021 issue of Drug Safety Update, up to 1 October 2021.
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Letters and medicine recalls sent to healthcare professionals in September 2021
A summary of recent letters, medicine recalls and notifications sent to healthcare professionals.
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Topical corticosteroids: information on the risk of topical steroid withdrawal reactions
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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COVID-19 vaccines and medicines: updates for September 2021
Recent information relating to COVID-19 vaccines and medicines that has been published since the August 2021 issue of Drug Safety Update, up to 9 September 2021.
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Letters and medicine recalls sent to healthcare professionals in August 2021
A summary of recent letters, medicine recalls and notifications sent to healthcare professionals
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COVID-19 vaccines: updates for August 2021
Recent information relating to COVID-19 vaccines that has been published since the July 2021 issue of Drug Safety Update.
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Letters and medicine recalls sent to healthcare professionals in July 2021
A summary of recent letters, medicine recalls and notifications sent to healthcare professionals
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Chloramphenicol eye drops containing borax or boric acid buffers: use in children younger than 2 years
Following a review of the available toxicological data and a calculation of daily exposure to boron from a typical dosing regimen, we have concluded that the balance between the benefits and risks of chloramphenicol eye drop…
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Herbal and homeopathic medicines: reminder to be vigilant for suspected adverse reactions and to report them to the Yellow Card scheme
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. Remind patients to check that a herbal or homeopathic medicin…
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Oral retinoid medicines (isotretinoin▼, alitretinoin▼, and acitretin▼): temporary monitoring advice during coronavirus (COVID-19) pandemic
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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COVID-19 vaccines: updates for July 2021
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 ext…
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Letters and medicine recalls sent to healthcare professionals in June 2021
A summary of letters and drug alerts recently sent to healthcare professionals.
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CDK4/6 inhibitors (abemaciclib▼, palbociclib▼, ribociclib▼): reports of interstitial lung disease and pneumonitis, including severe cases
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 …
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Atezolizumab (Tecentriq▼) and other immune-stimulatory anti-cancer drugs: risk of severe cutaneous adverse reactions (SCARs)
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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COVID-19 vaccines: updates for June 2021
A summary of advice recently issued by the MHRA relating to coronavirus (COVID-19), up to 11 June 2021.
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Letters and medicine recalls sent to healthcare professionals in May 2021
A summary of letters and recent medicine recalls and notifications sent to healthcare professionals.
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Emollients and risk of severe and fatal burns: new resources available
We inform healthcare professionals of the recent campaign to promote awareness of the risk and new resources available to support safe use following previous advice to health and care professionals.
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Levothyroxine: new prescribing advice for patients who experience symptoms on switching between different levothyroxine products
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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COVID-19 vaccines: updates for May 2021
A summary of advice recently issued by the MHRA relating to coronavirus (COVID-19), up to 13 May 2021.
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Letters and medicine recalls sent to healthcare professionals in April 2021
A summary of letters and recent medicine recalls and notifications sent to healthcare professionals.
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Polyethylene glycol (PEG) laxatives and starch-based thickeners: potential interactive effect when mixed, leading to an increased risk of aspiration
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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COVID-19 vaccines: updates for April 2021
A summary of advice recently issued by the MHRA relating to coronavirus (COVID-19), up to 21 April 2021.
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Letters and medicine recalls sent to healthcare professionals in March 2021
A summary of letters and recent medicine recalls and notifications sent to healthcare professionals.
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Bendamustine (Levact): increased risk of non-melanoma skin cancer and progressive multifocal encephalopathy (PML)
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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COVID-19 vaccines and medicines: updates for March 2021
A summary of advice recently issued by the MHRA relating to coronavirus (COVID-19), up to 18 March 2021.
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Letters and drug alerts sent to healthcare professionals in February 2021
A summary of letters and drug alerts recently sent to healthcare professionals.
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Ulipristal acetate 5mg (Esmya): further restrictions due to risk of serious liver injury
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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Pregabalin (Lyrica): reports of severe respiratory depression
Pregabalin has been associated with infrequent reports of severe respiratory depression, including some cases without the presence of concomitant opioid medicines. Patients with compromised respiratory function, respiratory …
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Alkindi (hydrocortisone granules): risk of acute adrenal insufficiency in children when switching from hydrocortisone tablet formulations to granules
When children receiving replacement therapy for adrenal insufficiency are being switched from hydrocortisone tablets to Alkindi granules, parents or carers should be informed of the need to be extra vigilant for symptoms of …
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Medicines in pregnancy and breastfeeding: new initiative for consistent guidance; report on optimising data for medicines used during pregnancy
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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COVID-19 vaccines and medicines: updates for February 2021
A summary of advice recently issued by the MHRA relating to coronavirus (COVID-19), up to 16 February 2021.
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Letters and drug alerts sent to healthcare professionals in January 2021
A summary of letters and drug alerts recently sent to healthcare professionals.
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Antiepileptic drugs in pregnancy: updated advice following comprehensive safety review
A review of the risks of major congenital malformations and of adverse neurodevelopmental outcomes for antiepileptic drugs by the Commission on Human Medicines has confirmed that lamotrigine (Lamictal) and levetiracetam (K…
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COVID-19 vaccines (Pfizer/BioNTech and COVID-19 Vaccine AstraZeneca): current advice
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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Dimethyl fumarate (Tecfidera): updated advice on the risk of progressive multifocal leukoencephalopathy (PML) associated with mild lymphopenia
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 …
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Fingolimod (Gilenya▼): updated advice about the risks of serious liver injury and herpes meningoencephalitis
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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SSRI/SNRI antidepressant medicines: small increased risk of postpartum haemorrhage when used in the month before delivery
SSRIs and SNRIs are known to increase bleeding risks due to their effect on platelet function. Data from observational studies suggest that the use of SSRI/SNRI antidepressants during the month before delivery may resul…
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Aminoglycosides (gentamicin, amikacin, tobramycin, and neomycin): increased risk of deafness in patients with mitochondrial mutations
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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Letters and drug alerts sent to healthcare professionals in December 2020
A summary of letters and drug alerts recently sent to healthcare professionals.
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Systemic and inhaled fluoroquinolones: small risk of heart valve regurgitation; consider other therapeutic options first in patients at risk
Fluoroquinolones should only be used after careful benefit-risk assessment and after consideration of other therapeutic options in patients at risk for heart valve regurgitation (incompetence).
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Erythromycin: caution required due to cardiac risks (QT interval prolongation); drug interaction with rivaroxaban
Erythromycin has been associated with events secondary to QT interval prolongation such as cardiac arrest and ventricular fibrillation. Erythromycin should not be given to patients with a history of QT interval prolongation…
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Erythromycin: update on known risk of infantile hypertrophic pyloric stenosis
Updates have been made to the magnitude of the known risk of infantile hypertrophic pyloric stenosis following exposure to erythromycin in infancy as a result of new epidemiological data. The risk is particularly increased i…
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Letters and drug alerts sent to healthcare professionals in November 2020
A summary of letters and drug alerts recently sent to healthcare professionals.
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Modafinil (Provigil): increased risk of congenital malformations if used during pregnancy
Modafinil potentially increases the risk of congenital malformations when used in pregnancy. Modafinil should not be used during pregnancy and women of childbearing potential must use effective contraception during treatment…
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Pirfenidone (Esbriet): risk of serious liver injury; updated advice on liver function testing
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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Ferric carboxymaltose (Ferinject▼): risk of symptomatic hypophosphataemia leading to osteomalacia and fractures
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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Bupropion (Zyban): risk of serotonin syndrome with use with other serotonergic drugs
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.