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HPRA Newsletter

The Irish Medicines Board (IMB) changed its name to the Health Products Regulatory Authority (HPRA) on 1 July 2014. The mission of the Health Products Regulatory Authority is 'to protect and enhance public and animal health through the regulation of medicines, medical devices and healthcare products'. They publish newsletters for health professionals on Drug Safety and Medical Devices.


HPRA Drug Safety Newsletters

Please note: Older issues of the Drug Safety Newsletter are available at www.hpra.ie.

2021

April 2021 - DSN 103

EU cooperation and guidance

HPRA Updates

March 2021 - DSN 102

COVID-19 Vaccine AstraZeneca┬« – conclusion of EMA review of thromboembolic events following vaccination

February 2021 - DSN 101
Special Edition on COVID-19 Vaccines Safety Monitoring Activities

2020

November 2020 - DSN 100

Welcome to the 100th Edition of the HPRA Drug Safety Newsletter

September 2020 - DSN 99

  • Erythromycin – Updated warnings regarding cardiovascular risks and infantile hypertrophic pyloric stenosis

May 2020 - DSN 97

  • Teratogenic risks of valproate-containing medicines (Epilim), restrictions for use, contraindication in women of childbearing potential and in pregnancy

April 2020 - DSN 96

  • Ulipristal acetate 5mg (Esmya) for uterine fibroids – suspension of marketing authorisation during ongoing review of liver injury risk

2019

November 2019 - DSN 95

  • Methotrexate – New measures to avoid dosing errors 

August 2019 - DSN 94

  • Montelukast – Reminder of risk of neuropsychiatric reactions and product information update

June 2019 - DSN 93

  • Domperidone-containing medicines: no longer approved for use in children due to lack of efficacy

April 2019 - DSN 92

  • Use of Lemtrada (alemtuzumab) restricted while European Medicines Agency (EMA) review is ongoing

2018

December 2018 - DSN 91

  • Fluoroquinolone antibiotics – EU review advises restrictions for certain infections and warns of rare but serious long lasting adverse reactions

November 2018 - DSN 90

  • Rivaroxaban (Xarelto) – Increase in all-cause mortality, thromboembolic and bleeding events in patients after transcatheter aortic valve replacement in aprematurely stopped clinical trial

August 2018 - DSN 89

  • Xofigo (radium-223 dichloride) – New restrictions for use

June 2018 - DSN 88

  • Granulocyte Colony Stimulating Factors (G-CSFs) – Risk of aortitis

April 2018 - DSN 87

  • Valproate (Epilim) : New contraindication, strengthened warnings and measures to prevent exposure during pregnancy

March 2018 - DSN 86

  • Esmya 5mg Tablets (Ulipristal acetate) - Important new warnings of serious liver injury and recommendations for liver monitoring
  • Xofigo (radium-223 dichloride) - Contraindicated in combination with Zytiga (abiraterone acetate) and prednisone/prednisolone
  • Mycophenolate - Updated contraceptive advice for male patients
  • Oral Retinoids - Outcome of EU review and updated warnings
  • Zinbryta (daclizumab beta) - EMA recommends immediate suspension and recall
  • Direct Healthcare Professional Communications published on the HPRA website since the last Drug Safety Newsletter

2017

December 2017 - DSN 85

  • Daclizumab (Zinbryta) and risk of severe liver injury – EU wide review concludes and confirms further restrictions to reduce risk of liver damage
  • New contraindication for injectable methylprednisolone products containing lactose (Solu-Medrone 40mg/vial) in patients with cows milk allergy
  • Warning about the use of Xofigo (radium-223 dichloride) in combination with Zytiga (abiraterone acetate) and prednisone or prednisolone – ongoing clinical trial shows an increased risk of death and fractures
  • Direct Healthcare Professional Communications published on the HPRA website since the last Drug Safety Newsletter

December 2017 - DSN 84

  • Conclusion of European Review of Gadolinium Contrast Agents – Publication of European Commission Decision

November 2017 - DSN 83

  • Quinine – reminder of safety profile and potential drug-drug interactions particularly where used for nocturnal leg cramps
  • Flucloxacillin and concomitant paracetamol – risk of high anion gap metabolic acidosis in very rare cases
  • Epoetins- new warnings on Severe Cutaneous Adverse Reactions (SCARs)
  • Adverse Reaction Reporting during 2016
  • Direct Healthcare Professional Communications published on the HPRA website since the last Drug Safety Newsletter

August 2017 - DSN 82

  • Daclizumab (Zinbryta) and risk of severe liver injury: initiation in multiple sclerosis now restricted, promptly review patients already on treatment
  • Gabapentin – respiratory depression without concomitant opioid use
  • Amoxicillin; co-amoxiclav – very rare reports of DRESS (drug reaction with eosinophilia and systemic symptoms)
  • Direct Healthcare Professional Communications published on the HPRA website since the last Drug Safety Newsletter

July 2017 - DSN 81

  • Valproate (Epilim) and Developmental Disorders: Update on ongoing EU review
  • Domperidone-containing medicines: reminder of the risk of cardiac adverse reactions-restricted indication, contraindications and reduced dose and duration of use
  • New CPD e-learning module on reporting suspected adverse drug reactions
  • Direct Healthcare Professional Communications published on the HPRA website since the last Drug Safety Newsletter

April 2017 - DSN 80

  • Valproate-containing medicines – new EU review initiated

March 2017 - DSN 79

  • Fluconazole – reminder not to use in pregnancy
  • SGLT2 inhibitors and risk of lower limb amputation (mainly toe)
  • Reports of keratoacanthoma with ingenol mebutate
  • Adverse reaction reporting - reminder

 

Email: library@icgp.ie, Tel: 01 6763705, Fax: 01 6765850