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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