Propylthiouracil and Carbimazole: Product label update of Pregnancy category from “C” to “D”

Drug Safety Updates, Global Safety Alerts, Medicinal Product Updates, Product Label Updates, TGA-Australia, , ,

Propylthiouracil and Carbimazole are the medications used in the treatment of hyperthyroidism. The product information (PI) documents which were previously having status of category “C” for use in pregnant women is being updated to category “D” Category C status: Based on the mechanism of action & pharmacological activity, suspicion of causing harmful effects to the…

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Potential risk of congenital malformations with the use of Modafinil during pregnancy

Drug Safety Alert, Global Safety Alerts, HPRA-Ireland, Medicinal Product Updates, Voluntary ADR reporting, , ,

Ireland Health authority, Health Products Regulatory Authority – HPRA has released a drug safety alert for modafinil association with congenital malformations (congenital heart defects, hypospadias and orofacial clefts) in foetus when exposed to a pregnant woman or to women of childbearing potential. Modafinil is a wakefulness promoting medicinal product used in the treatment of too…

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