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Carbimazole: increased risk of congenital malformations; strengthened advice on contraception
Carbimazole is associated with an increased risk of congenital malformations, especially when administered in the first trimester of pregnancy and at high doses.
- Therapeutic area:
- Endocrinology, diabetology and metabolism and 2 others
- Published:
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Carbimazole: risk of acute pancreatitis
If acute pancreatitis occurs during treatment with carbimazole, immediately and permanently stop treatment.
- Therapeutic area:
- Endocrinology, diabetology and metabolism and 1 others
- Published:
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SGLT2 inhibitors: reports of Fournier’s gangrene (necrotising fasciitis of the genitalia or perineum)
If Fournier’s gangrene is suspected, stop the SGLT2 inhibitor and start treatment urgently (including antibiotics and surgical debridement).
- Therapeutic area:
- Anaesthesia and intensive care and 6 others
- Published:
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Letters and drug alerts sent to healthcare professionals in January 2019
Letters were sent to healthcare professionals about Lartruvo▼ (olaratumab), quadrivalent influenza vaccine (split virion, inactivated), SGLT2 inhibitors, and carbimazole and thiamazole (synonym: methimazole)-containing products. Class 2 medicines recalls were issued for batches of irbesartan/hydrochlorothiazide and irbesartan tablets.
- Therapeutic area:
- Anaesthesia and intensive care and 8 others
- Published:
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Medical Device Alerts issued in January 2019
Alerts were issued about FreeStyle Libre flash glucose sensors and Arjo Minstrel passive floor lifts (portable hoist).
- Therapeutic area:
- Anaesthesia and intensive care and 2 others
- Published:
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Fibrates: first-line treatment not recommended
Healthcare professionals should not prescribe them to newly diagnosed patients as first-line treatment, except for those with severe hypertriglyceridaemia or those who cannot take statins.
- Therapeutic area:
- Cardiovascular disease and lipidology
- Published:
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Tapentadol (Palexia): risk of seizures and reports of serotonin syndrome when co-administered with other medicines
Tapentadol may increase seizure risk in patients taking other medicines that lower seizure threshold, for example, antidepressants and antipsychotics.
- Therapeutic area:
- Neurology and 3 others
- Published:
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Ipilimumab (Yervoy): reports of cytomegalovirus (CMV) gastrointestinal infection or reactivation
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 infections such as cytomegalovirus (CMV).
- Therapeutic area:
- Cancer and 3 others
- Published:
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Yellow Card App: download the updated App to receive the latest MHRA safety news and report suspected side effects, including in pregnancy
The Yellow Card App has been updated to make it easier to use, to have useful new features, and to support reporting a suspected reaction related to medicine exposure during pregnancy.
- Published:
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Letters and drug alerts sent to healthcare professionals in December 2018
In December 2018, a letter was sent to notify healthcare professionals of the discontinuation of Zovirax (Aciclovir) eye ointment.
- Therapeutic area:
- Cardiovascular disease and lipidology and 3 others
- Published:
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Medical Device Alerts issued in December 2018
A notice was issued by Allergan about the availability of textured breast implants in the UK.
- Published:
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Valproate medicines: are you acting in compliance with the pregnancy prevention measures?
Although use of valproate medicines in female patients continues to slowly decline, there is wide variation in prescribing between Clinical Commissioning Groups (CCGs).
- Therapeutic area:
- Anaesthesia and intensive care and 5 others
- Published:
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Emollients: new information about risk of severe and fatal burns with paraffin-containing and paraffin-free emollients
Warnings about the risk of severe and fatal burns are being extended to all paraffin-based emollients regardless of paraffin concentration.
- Therapeutic area:
- Anaesthesia and intensive care and 4 others
- Published:
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Direct-acting antivirals for chronic hepatitis C: risk of hypoglycaemia in patients with diabetes
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.
- Therapeutic area:
- Endocrinology, diabetology and metabolism and 2 others
- Published:
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Hydrocortisone muco-adhesive buccal tablets: should not be used off-label for adrenal insufficiency in children due to serious risks
Risk of insufficient cortisol absorption and life-threatening adrenal crisis if muco-adhesive buccal tablets are used as adrenal replacement therapy.
- Therapeutic area:
- Endocrinology, diabetology and metabolism and 1 others
- Published:
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Letters and drug alerts sent to healthcare professionals in November 2018
A pharmacy-level recall of some valsartan-containing products took place due to possible contamination, including advice to healthcare professionals and information on supply.
- Therapeutic area:
- Cancer and 3 others
- Published:
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Medical Device Alerts issued in November 2018
Alerts were issued about ConvaTec Suction catheters, gastro-enteral tubes, intermittent urology catheters and sterile urine drainage bags, CME T34 ambulatory syringe pumps, and HeartStart MRx monitor/defibrillators.
- Therapeutic area:
- Anaesthesia and intensive care and 3 others
- Published:
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Oral lidocaine-containing products for infant teething: only to be available under the supervision of a pharmacist
Oral lidocaine-containing products for infant teething are only to be available under the supervision of a pharmacist so that parents and caregivers can receive guidance about managing infant teething symptoms.
- Therapeutic area:
- Dentistry and 1 others
- Published:
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Hydrochlorothiazide: risk of non-melanoma skin cancer, particularly in long-term use
Advise patients taking hydrochlorothiazide-containing products of the cumulative, dose-dependent risk of non-melanoma skin cancer, particularly in long-term use, and the need to regularly check for (and report) any suspicious skin lesions or moles.
- Therapeutic area:
- Cancer and 3 others
- Published:
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Systemic and inhaled fluoroquinolones: small increased risk of aortic aneurysm and dissection; advice for prescribing in high-risk patients
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.
- Therapeutic area:
- Anaesthesia and intensive care and 2 others
- Published:
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Sildenafil (Revatio and Viagra): reports of persistent pulmonary hypertension of the newborn (PPHN) following in-utero exposure in a clinical trial on intrauterine growth restriction
Sildenafil is not authorised for use in pregnancy for the treatment of intrauterine growth restriction.
- Therapeutic area:
- Cardiovascular disease and lipidology and 4 others
- Published:
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Support Yellow Card: improve the safety of medicines in pregnancy and breastfeeding, and in babies and children
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.
- Therapeutic area:
- Obstetrics, gynaecology and fertility and 1 others
- Published:
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Letters and drug alerts sent to healthcare professionals in October 2018
Letters were sent to healthcare professionals about Jext adrenaline autoinjectors, rivaroxaban, Ozurdex 700 micrograms intravitreal implant, sildenafil, hydrochlorothiazide, and Epilim Chronosphere (sodium valproate).
- Therapeutic area:
- Anaesthesia and intensive care and 13 others
- Published:
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Medical Device Alerts issued in October 2018
An alert was recently issued by MHRA about CoaguChek Test Strips for Point of Care and Home Use due to a risk of false high results.
- Therapeutic area:
- Cardiovascular disease and lipidology and 2 others
- Published:
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Rivaroxaban (Xarelto▼) after transcatheter aortic valve replacement: increase in all-cause mortality, thromboembolic and bleeding events in a clinical trial
Rivaroxaban treatment in patients who undergo transcatheter aortic valve replacement (TAVR) should be stopped and switched to standard of care.
- Therapeutic area:
- Cardiovascular disease and lipidology and 1 others
- Published:
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Ritonavir-containing products: reports of interaction with levothyroxine leading to reduced thyroxine levels
Monitor thyroid-stimulating hormone (TSH) in patients treated with levothyroxine for at least the first month after starting and ending ritonavir treatment.
- Therapeutic area:
- Endocrinology, diabetology and metabolism and 2 others
- Published:
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Ponatinib (Iclusig▼): reports of posterior reversible encephalopathy syndrome
Interrupt treatment if posterior reversible encephalopathy syndrome (PRES) is confirmed and resume treatment only once the event is resolved and the benefit of continued treatment outweighs the risk of PRES.
- Therapeutic area:
- Cancer and 2 others
- Published:
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Transdermal fentanyl patches: life-threatening and fatal opioid toxicity from accidental exposure, particularly in children
Provide clear information to patients and caregivers about how to minimise the risk of accidental exposure and the importance of appropriate disposal of patches.
- Therapeutic area:
- Anaesthesia and intensive care and 3 others
- Published:
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Letters and drug alerts sent to healthcare professionals in September 2018
A supply disruption alert was issued by the Department of Health & Social Care (DHSC) on EpiPen and EpiPen Junior; see MHRA advice on extension of use beyond the expiry date for certain batches of EpiPen 300 microgram adrenaline autoinjectors.
- Therapeutic area:
- Anaesthesia and intensive care and 8 others
- Published:
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Medical Device Alerts issued in September 2018
Alerts were recently issued by MHRA about flex connectors in Halyard closed suction kits; SureSigns VS & VM patient monitors and viewing stations; and Zimmer Biomet trauma guide wires.
- Therapeutic area:
- Anaesthesia and intensive care and 5 others
- Published:
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Valproate Pregnancy Prevention Programme: actions required now from GPs, specialists, and dispensers
Valproate medicines must not be used in women of childbearing potential unless the Pregnancy Prevention Programme is in place.
- Therapeutic area:
- Neurology and 3 others
- Published:
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Xofigo▼ (radium-223-dichloride): new restrictions on use due to increased risk of fracture and trend for increased mortality seen in clinical trial
Now only authorised for use in patients with symptomatic bone metastases and no known visceral metastases who have had 2 previous systemic treatments for metastatic castration-resistant prostate cancer or who cannot receive other systemic treatments.
- Therapeutic area:
- Cancer and 2 others
- Published:
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Daclizumab beta (Zinbryta▼): risk of immune-mediated encephalitis – some cases several months after stopping treatment
Monitoring for encephalitis should continue for 12 months following discontinuation of daclizumab.
- Therapeutic area:
- Anaesthesia and intensive care and 3 others
- Published:
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Nusinersen (Spinraza▼): reports of communicating hydrocephalus; discuss symptoms with patients and carers and investigate urgently
Advise patients and their caregivers to seek urgent medical attention if any signs or symptoms of communicating hydrocephalus develop during nusinersen therapy for spinal muscular atrophy.
- Therapeutic area:
- Anaesthesia and intensive care and 2 others
- Published:
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Letters and drug alerts sent to healthcare professionals in August 2018
Letters were sent about daclizumab beta (Zinbryta▼), alteplase (Actilyse), Esmya (ulipristal acetate), and Xofigo▼ (radium-223-dichloride).
- Therapeutic area:
- Anaesthesia and intensive care and 12 others
- Published:
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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.
- Therapeutic area:
- GI, hepatology and pancreatic disorders and 1 others
- Published:
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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▼).
- Therapeutic area:
- Cancer and 12 others
- Published:
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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
- Therapeutic area:
- Anaesthesia and intensive care and 5 others
- Published:
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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.
- Therapeutic area:
- Immunosuppression and transplantation and 3 others
- Published:
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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.
- Therapeutic area:
- Paediatrics and neonatology and 1 others
- Published:
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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.
- Therapeutic area:
- Anaesthesia and intensive care and 4 others
- Published:
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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.
- Therapeutic area:
- Anaesthesia and intensive care and 2 others
- Published:
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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.
- Therapeutic area:
- Anaesthesia and intensive care and 22 others
- Published:
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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).
- Therapeutic area:
- Anaesthesia and intensive care and 9 others
- Published:
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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.
- Therapeutic area:
- Anaesthesia and intensive care and 3 others
- Published:
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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.
- Therapeutic area:
- Infectious disease and 2 others
- Published:
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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.
- Therapeutic area:
- Cancer and 2 others
- Published:
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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.
- Therapeutic area:
- Cancer and 1 others
- Published:
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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.
- Therapeutic area:
- Cancer and 6 others
- Published:
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Medical Device Alerts issued in May 2018
An alert was recently issued by MHRA on JM103 and JM105 Jaundice Meters.
- Therapeutic area:
- Anaesthesia and intensive care and 2 others
- Published:
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