HPRA Drug Safety Newsletter Edition 94

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 The latest edition of the HPRA Drug Safety Newsletter (DSN) includes important updates to the support the safe and effective use of the following medicines:

Montelukast - Reminder of the risk of neuropsychiatric reactions and product information update

Modafinal-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

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