Reminder for importance of adhering to risk minimization measures for the safe and effective usage of Direct oral anticoagulants (DOACs)

EMA-European Medicines Agency, Global Safety Alerts, HPRA-Ireland, Medicinal Product Updates, PRAC, Risk Minimization Measures, Voluntary ADR reporting, , ,

Direct oral anticoagulants (DOACs) are the medications used in the prevention of thrombosis in several cardiovascular contexts viz. in the treatment and prevention of blood clots in veins, and for the prevention of stroke and embolism in people with atrial fibrillation. DOACs are direct factor Xa (activated factor X) inhibitors which included apixaban (Eliquis and…

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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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Drug safety updates from Ireland health authority (HPRA)-May 2020

Drug Safety Alert, Drug Safety Updates, Pharmacovigilance, Safety Communications, Voluntary ADR reporting, ,

Below Safety Updates for medicinal products were released for the month of May-2020 by Ireland Health Authority-Health Products Regulatory Agency (HPRA)   A confirmed “Negative Benefit-Risk Profile” for Picato (ingenol mebutate) Risk of abnormal and aggressive behaviors with Levetiracetam use Restricted use of Cyproterone acetate due to risk of meningioma Restricted use of thyroid drugs…

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The risk of skin cancer associated with Ingenol mebutate: Suspension of Ingenol mebutate use during PRAC review period.

Drug Safety Updates, Pharmacovigilance, Safety Communications, ,

Ingenol mebutate, which is commonly known as milkweed is indicated for the cutaneous treatment of non-hyperkeratotic, non‑hypertrophic actinic keratosis in adults.  The health authority of Ireland has cautioned patients and health care professionals on the use of this product in patients having history of skin cancer. It was reported in a randomized study results in…

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