634 updates
  1. Rivaroxaban (Xarelto▼): reminder that 15 mg and 20 mg tablets should be taken with food

    MHRA has received a small number of reports suggesting lack of efficacy (thromboembolic events) in patients taking 15 mg or 20 mg rivaroxaban on an empty stomach; remind patients to take 15 mg or 20 mg rivaroxaban tablets wi…

  2. Letters and drug alerts sent to healthcare professionals in June 2019

    Letters were sent about Myocrisin (sodium aurothiomalate), Cerliponase alfa (Brineura▼), Darzalex▼(daratumumab), retinoids▼, and febuxostat (Adenuric).

  3. Medical Device Alerts issued in June 2019

    An alert was issued about Dialog+ haemodialysis machines.

  4. Direct-acting oral anticoagulants (DOACs): increased risk of recurrent thrombotic events in patients with antiphospholipid syndrome

    A clinical trial has shown an increased risk of recurrent thrombotic events associated with rivaroxaban compared with warfarin, in patients with antiphospholipid syndrome and a history of thrombosis.

  5. GLP-1 receptor agonists: reports of diabetic ketoacidosis when concomitant insulin was rapidly reduced or discontinued

    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.

  6. Lartruvo▼ (olaratumab): withdrawal of the EU marketing authorisation due to lack of efficacy

    The ANNOUNCE study failed to show clinical efficacy for olaratumab in its current indication of advanced soft tissue sarcoma and the benefit risk balance is therefore now considered negative.

  7. Oral retinoid medicines▼: revised and simplified pregnancy prevention educational materials for healthcare professionals and women

    New prescriber checklists, patient reminder cards, and pharmacy checklists are available to support the Pregnancy Prevention Programme in women taking acitretin, alitretinoin, and isotretinoin.

  8. Letters and drug alerts sent to healthcare professionals in May 2019

    Letters were sent about tofacitinib (Xeljanz▼), Trisenox (arsenic trioxide), lapatinib (Tyverb), direct-acting oral anticoagulants, and Lartruvo▼ (olaratumab).

  9. Medical Device Alerts issued in May 2019

    Alerts were issued about paclitaxel drug coated balloons (DCBs) and implantable drug-eluting stents (DESs) in the treatment of patients with peripheral artery disease, and Aisys and Aisys CS2 anaesthesia devices.

  10. Lemtrada (alemtuzumab) and serious cardiovascular and immune-mediated adverse reactions: new restrictions to use and strengthened monitoring requirements

    While an urgent EU safety review evaluates reports of serious cardiovascular events and immune-mediated reactions, including autoimmune hepatitis, the use of alemtuzumab (Lemtrada) has been restricted and strengthened requir…

  11. Tofacitinib (Xeljanz▼): restriction of 10 mg twice-daily dose in patients at high risk of pulmonary embolism while safety review is ongoing

    Following observation in a clinical study of an increased risk of pulmonary embolism and overall mortality with tofacitinib 10 mg twice-daily in rheumatoid arthritis, a safety review has started and new contraindications int…

  12. Magnesium sulfate: risk of skeletal adverse effects in the neonate following prolonged or repeated use in pregnancy

    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.

  13. Yellow Card: please help to reverse the decline in reporting of suspected adverse drug reactions

    2018 saw a fall in reporting of suspected adverse drug reactions (ADRs) to the Yellow Card Scheme from key reporter groups, including GPs, pharmacists, and hospital doctors.

  14. Letters and drug alerts sent to healthcare professionals in April 2019

    Letters were sent about alemtuzumab (Lemtrada), Selenase (sodium selenite pentahydrate), and Erelzi▼ (etanercept).

  15. Medical Device Alerts issued in April 2019

    An alert was issued about Moift Mover 180/205 mobile hoist and Molift Air ceiling hoist.

  16. Yellow fever vaccine (Stamaril) and fatal adverse reactions: extreme caution needed in people who may be immunosuppressed and those 60 years and older

    We have recently received 2 reports of fatal adverse reactions to the yellow fever vaccine (Stamaril).

  17. Valproate medicines and serious harms in pregnancy: new Annual Risk Acknowledgement Form and clinical guidance from professional bodies to support compliance with the Pregnancy Prevention Programme

    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…

  18. Belimumab (Benlysta▼): increased risk of serious psychiatric events seen in clinical trials

    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…

  19. Pregabalin (Lyrica), gabapentin (Neurontin) and risk of abuse and dependence: new scheduling requirements from 1 April

    As of 1 April 2019, pregabalin and gabapentin are controlled under the Misuse of Drugs Act 1971 as Class C substances and scheduled under the Misuse of Drugs Regulations 2001 as Schedule 3.

  20. Elvitegravir boosted with cobicistat: avoid use in pregnancy due to risk of treatment failure and maternal-to-child transmission of HIV-1

    Pharmacokinetic data indicate exposure of elvitegravir boosted with cobicistat (Genvoya▼, Stribild) is lower during the second and third trimesters of pregnancy than postpartum.

  21. Letters and drug alerts sent to healthcare professionals in March 2019

    Letters were sent about Xeljanz▼ (tofacitinib), ranitidine, Nulojix (belatacept), fluoroquinolone antibiotics, Genvoya▼, Stribild▼, Tybost, and belimumab (Benlysta▼).

  22. Medical Device Alerts issued in March 2019

    Alerts were issued about Pagewriter Cardiographs and Efficia Monitors and Fresenius 5008 & 5008S haemodialysis machines.

  23. Fluoroquinolone antibiotics: new restrictions and precautions for use due to very rare reports of disabling and potentially long-lasting or irreversible side effects

    Disabling, long-lasting or potentially irreversible adverse reactions affecting musculoskeletal and nervous systems have been reported very rarely with fluoroquinolone antibiotics.

  24. Onivyde (irinotecan, liposomal formulations): reports of serious and fatal thromboembolic events

    Onivyde has been associated with reports of serious thromboembolic events, such as pulmonary embolism, venous thrombosis, and arterial thromboembolism.

  25. Medicines with teratogenic potential: what is effective contraception and how often is pregnancy testing needed?

    New guidance on contraceptive methods and frequency of pregnancy testing to reduce inadvertent exposures during pregnancy in a woman taking a medicine of teratogenic potential.

  26. Letters and drug alerts sent to healthcare professionals in February 2019

    Letters were sent about Vyxeos (cytarabine, daunorubicin) and Ozurdex 700 micrograms intravitreal implant (dexamethasone).

  27. Medical Device Alerts issued in February 2019

    Alerts issued include important actions for enFlow IV fluid and blood warmers due to a risk of unsafe levels of aluminium leaching from the device.

  28. 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.

  29. Carbimazole: risk of acute pancreatitis

    If acute pancreatitis occurs during treatment with carbimazole, immediately and permanently stop treatment.

  30. 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).

  31. 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 produ…

  32. Medical Device Alerts issued in January 2019

    Alerts were issued about FreeStyle Libre flash glucose sensors and Arjo Minstrel passive floor lifts (portable hoist).

  33. 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.

  34. 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.

  35. 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 infectio…

  36. 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.

  37. 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.

  38. Medical Device Alerts issued in December 2018

    A notice was issued by Allergan about the availability of textured breast implants in the UK.

  39. 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).

  40. 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.

  41. 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.

  42. 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.

  43. 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.

  44. 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.

  45. 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.

  46. 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 suspiciou…

  47. 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.

  48. 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.

  49. 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.

  50. 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).