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.