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Home News Latest News HPRA Drug Safety Newsletter Edition 94

HPRA Drug Safety Newsletter Edition 94

Home News Latest News HPRA Drug Safety Newsletter Edition 94
September 12, 2019

The 94th edition of the HPRA Drug Safety Newsletter.

The 94th edition of the HPRA Drug Safety Newsletter includes information on the following medicines:

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

  • Modafinil-containing medicines – potential risk of congenital malformations when administered during pregnancy

  • RoActemra® (tocilizumab) – rare risk of serious hepatic injury including acute liver failure requiring transplantation

  • Febuxostat – Increased risk of cardiovascular death and all-cause mortality in patients treated with febuxostat in the CARES study

  • Darzalex (daratumumab) – Risk of Hepatitis B reactivation

The online versions of the DSN contains hyperlinks to product information and other documents on the HPRA and European Medicines Agency (EMA) websites, as appropriate.

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