GOV.UK
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Esmya (ulipristal acetate) and risk of serious liver injury: new restrictions to use and requirements for liver function monitoring before, during, and after treatment
More than one treatment course is authorised only in women who are not eligible for surgery, and liver function monitoring is to be carried out in all women treated with Esmya.
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Letters and drug alerts sent to healthcare professionals in July 2018
Letters were sent about valproate medicines, atezolizumab (Tecentriq▼), and nusinersen (Spinraza▼).
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Medical Device Alerts issued in July 2018
Alerts were recently issued about Novaline haemodialysis bloodlines used with Baxter/Gambro haemodialysis machines and Alaris and Asena enteral syringe pumps
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Darunavir boosted with cobicistat: avoid use in pregnancy due to risk of treatment failure and maternal-to-child transmission of HIV-1
New pharmacokinetic data show mean exposure of darunavir (brand name Prezista) boosted with cobicistat (available in combination in Rezolsta▼, Symtuza▼) to be lower during the second and third trimesters of pregnancy than during 6–12 weeks postpartum.
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Pressurised metered dose inhalers (pMDI): risk of airway obstruction from aspiration of loose objects
Remind patients to check and remove the mouthpiece cover properly before inhaling a dose and to shake the inhaler to remove loose objects that may have become trapped in the inhaler during storage.
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Eltrombopag (Revolade): reports of interference with bilirubin and creatinine test results
If bilirubin and/or creatinine test results are inconsistent with clinical observations, request re-testing using another method to determine the validity of the result.
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Parenteral amphotericin B: reminder of risk of potentially fatal adverse reaction if formulations confused
Following receipt of a third case of fatal medication error caused by the administration of Fungizone (a non-lipid-based formulation of amphotericin B) instead of a lipid-based formulation (AmBisome, Abelcet), we remind healthcare professionals that these formulations are not interchangeable.
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Medicines taken during pregnancy: please report suspected adverse drug reactions, including in the baby or child, on a Yellow Card
Report to the Yellow Card Scheme suspected adverse reactions associated with medicines taken during pregnancy experienced by women or the baby or child.
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Letters sent to healthcare professionals in June 2018
Letters were sent about Cetrotide (cetrorelix acetate), Eperzan▼(albiglutide), darunavir/cobicistat, Keytruda▼ (pembrolizumab), Denzapine (clozapine) 50 mg/mL oral suspension, and Bleo-Kyowa (bleomycin sulphate).
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Medical Device Alerts issued in June 2018
Alerts were recently issued by MHRA about Smiths Medical medication cassette reservoirs, Alaris Smartsite add-on bag access devices, and Combur10 Test UX and Chemstrip 10 A urinalysis test strips.
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Dolutegravir (Tivicay▼, Triumeq▼, Juluca▼): signal of increased risk of neural tube defects; do not prescribe to women seeking to become pregnant; exclude pregnancy before initiation and advise use of effective contraception
New safety recommendations have been issued while an EU review evaluates cases of neural tube defects in babies born to mothers who became pregnant while taking the HIV medicine dolutegravir.
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Denosumab (Xgeva▼) for giant cell tumour of bone: risk of clinically significant hypercalcaemia following discontinuation
Monitor patients for signs and symptoms of hypercalcaemia after discontinuation of denosumab treatment for giant cell tumour of bone.
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Denosumab (Xgeva▼) for advanced malignancies involving bone: study data show new primary malignancies reported more frequently compared to zoledronate
A pooled analysis has shown an increased rate of new primary malignancies in patients given Xgeva (1-year cumulative incidence 1.1%) compared with those given zoledronic acid (0.6%), when used in the indication of the prevention of skeletal-related events with advanced malignancies involving bone.
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Letters sent to healthcare professionals in May 2018
Letters were sent about azithromycin, Lynparza▼(Olaparib), Xgeva▼ (denosumab), Lymphoseek (tilmanocept), ReoPro (abciximab) and dolutegravir; you still have time to complete a quick survey to tell us your views on the way medicines safety issues are communicated.
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Medical Device Alerts issued in May 2018
An alert was recently issued by MHRA on JM103 and JM105 Jaundice Meters.
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Valproate medicines (Epilim▼, Depakote▼): Pregnancy Prevention Programme materials online
Use materials online now and hardcopies arriving over the coming weeks by post to ensure women and girls of childbearing potential on valproate medicines meet the requirements of the Pregnancy Prevention Programme.
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Braltus (tiotropium): risk of inhalation of capsule if placed in the mouthpiece of the inhaler
Train patients to place the Braltus capsule in the correct chamber of the Zonda inhaler.
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Letters sent to healthcare professionals in April 2018
Letters were sent about insulin Fiasp and Tresiba and Inhixa (enoxaparin sodium); use survey to feedback your thoughts on Direct Healthcare Professional Communications (DHPCs) and on the way medicines safety issues are communicated.
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Medical Device Alerts issued in April 2018; recent alert about Accu-Chek blood glucose test strips
An alert was issued recently about Accu-Chek Aviva, Accu-Chek Performa, and Accu-Chek Inform II test strips – risk of strip error messages and false high and low blood glucose results.
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Valproate medicines (Epilim▼, Depakote▼): contraindicated in women and girls of childbearing potential unless conditions of Pregnancy Prevention Programme are met
Valproate medicines must no longer be used in women or girls of childbearing potential unless a Pregnancy Prevention Programme is in place.
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Obeticholic acid (Ocaliva▼): risk of serious liver injury in patients with pre-existing moderate or severe hepatic impairment; reminder to adjust dosing according to liver function monitoring
We are aware of reports of serious liver injuries and deaths in patients with primary biliary cholangitis with pre-existing moderate or severe liver impairment who were not adequately dose-adjusted.
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Suspect an adverse reaction? Yellow Card it!
Any healthcare professional can submit a Yellow Card, including students.
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Letters sent to healthcare professionals in March 2018
Letters were sent to healthcare professionals about Zinbryta▼ (daclizumab beta), Lynparza 50 mg capsules, and radium-223-dichloride (Xofigo▼).
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Medical Device Alerts issued in March 2018
An alert was issued about T34 ambulatory syringe pumps.
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Daclizumab (Zinbryta▼): suspension and recall for safety reasons; review patients as soon as possible and start alternative therapy
The European Medicines Agency (EMA) has recommended the immediate suspension of the marketing authorisation and recall of daclizumab (Zinbryta) in the EU following reports of serious inflammatory brain disorders, including encephalitis and meningoencephalitis, in patients with multiple sclerosis.
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Esmya (ulipristal acetate) for uterine fibroids: do not initiate or re-start treatment; monitor liver function in current and recent users
Temporary safety measures are in place while an EU review investigates the link between cases of serious liver injury, including 4 cases requiring liver transplantation, and Esmya for uterine fibroids.
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Head lice eradication products: risk of serious burns if treated hair is exposed to open flames or other sources of ignition, eg, cigarettes
Pharmacists should tell people about the risk of fire when they discuss head lice eradication options.
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Confidential prescribing and patient safety reports on key indicators now available free for GPs
Confidential reports designed to help you improve the quality of your prescribing and patient safety are now available for practices that contribute to the MHRA’s Clinical Practice Research Datalink.
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Letters sent to healthcare professionals in February 2018
Letters were sent about ellaOne, ERWINASE, Eperzan▼, Ocaliva▼, Velcade, Esmya, and Bleo-Kyowa.
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Medical Device Alerts issued in February 2018
Alerts were recently issued about RUSCH rectal/pharyngeal temperature sensors and Aquilon nebulisers.
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Misoprostol vaginal delivery system (Mysodelle): reports of excessive uterine contractions (tachysystole) unresponsive to tocolytic treatment
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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Mycophenolate mofetil, mycophenolic acid: updated contraception advice for male patients
Mycophenolate mofetil and its active metabolite mycophenolic acid, both used to prevent transplant rejection, are teratogenic and genotoxic.
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Gadolinium-containing contrast agents: Omniscan and iv Magnevist no longer authorised, MultiHance and Primovist for use only in liver imaging
Omniscan and intravenous Magnevist are now no longer authorised for use and a product recall of any existing unexpired stock is underway.
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Letters sent to healthcare professionals in January 2018
Letters were sent about Buccolam (midazolam), misoprostol vaginal delivery system (Mysodelle), noradrenaline, Relenza (zanamivir), mycophenolate mofetil/mycophenolic acid, Flolan, and Fludara.
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Medical Device Alerts issued in January 2018
Alerts were recently issued by MHRA about all Philips HeartStart MRx monitors/defibrillators and Boston Scientific pacemakers and CRT-P.
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Daclizumab (Zinbryta▼) and risk of severe liver injury: new restrictions to use and strengthened liver monitoring
The use of daclizumab (daclizumab beta) is now restricted to adults with relapsing multiple sclerosis who have had an inadequate response to at least 2 other disease-modifying therapies (DMTs) and for whom other DMTs are contraindicated or unsuitable.
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Recombinant human erythropoietins: very rare risk of severe cutaneous adverse reactions (SCARs)
Recombinant human erythropoietin (r-HuEPO) treatment has been associated with very rare cases of life-threatening severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN).
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Drug-name confusion: reminder to be vigilant for potential errors
Take particular care when prescribing or dispensing medicines that could be confused with others (ie, they sound-alike or look-alike).
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Co-dydramol: prescribe and dispense by strength to minimise risk of medication error
Previously co-dydramol (dihydrocodeine/paracetamol) was available only in the ratio 1:50 (co-dydramol 10/500 mg).
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Herbal medicines: report suspected adverse reactions to the Yellow Card Scheme
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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Letters sent to healthcare professionals in December 2017
Letters were sent about cladribine (Litak and Leustat), radium-223-dichloride (Xofigo▼), and ERWINASE.
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Medical Device Alerts issued in December 2017
Alerts were recently issued about BD Alaris/Asena syringe pumps and Maxter Catheters nasogastric (NG) feeding tubes.
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Gadolinium-containing contrast agents: removal of Omniscan and iv Magnevist, restrictions to the use of other linear agents
A review has found that low levels of gadolinium can be retained in the brain and other tissues after administration of gadolinium-containing contrast agents (GdCAs).
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Cladribine (Litak, Leustat) for leukaemia: reports of progressive multifocal encephalopathy (PML); stop treatment if PML suspected
Consider progressive multifocal encephalopathy (PML) in the differential diagnosis for patients with new or worsening neurological signs or symptoms, even several years after treatment with cladribine.
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Radium-223 dichloride (Xofigo▼): do not use in combination with abiraterone and prednisone/prednisolone, following clinical trial signal of increased risk of death and fractures
A European review has begun into the safety of radium-223 dichloride following an observed increase in the incidence of deaths and fractures in patients with chemotherapy-naive metastatic castration-resistant prostate cancer receiving radium-223 dichloride in combination with abiraterone acetate (Zytiga) and prednisone/prednisolone as part of a clinical trial.
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Eluxadoline (Truberzi▼): risk of pancreatitis; do not use in patients who have undergone cholecystectomy or in those with biliary disorders
Cases of pancreatitis, with or without sphincter of Oddi spasm, have been reported in patients taking eluxadoline.
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Fingolimod (Gilenya▼): new contraindications in relation to cardiac risk
Fingolimod can cause persistent bradycardia, which can increase the risk of serious cardiac arrhythmias.
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Fingolimod (Gilenya▼): updated advice about risk of cancers and serious infections
Monitor patients closely for skin cancers.
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Letters sent to healthcare professionals in November 2017
Letters were sent about eluxadoline (Truberzi), fingolimod (Gilenya), Bleo-Kyowa (bleomycin sulphate), Buccolam (midazolam), and ERWINASE.
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Medical Device Alert issued in November 2017
An alert was recently issued about Oxoid ceftazidime antimicrobial susceptibility test discs.
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