An unfavourable benefit-risk profile for Ulipristal acetate 5 mg: A drug withdrawal story

Ulipristal acetate is a selective progesterone receptor modulator which acts by preventing the effects of the female progesterone hormone. This medicine is available in two brand names in market for the below two different therapeutic uses. Esmya® tablets comprising 5 mg ulipristal acetate and therapeutically indicated for Uterine fibroids. It is used for the treatment

Restricted use of oral antihistamines for sedation in children: MedSafe Update

Antihistamines are class of medications which are commonly used in getting relief from allergic symptoms. The most common therapeutic/adverse effect produced by antihistaminergic drugs is drowsiness (sleepiness). These sedating antihistaminic drugs are available as over the counter (OTC) medicine category and can be used for a range of conditions in both adults and children. MedSafe,

TRISENOX (arsenic trioxide) and potential medication errors: DHPC from Teva Pharmaceuticals

Arsenic trioxide is a chemotherapeutic medication used in the treatment of newly diagnosed low-to-intermediate risk acute promyelocytic leukaemia (APL) and relapsed/refractory APL characterized by the presence of leukaemia/retinoic-acid-receptor-alpha (PML/RAR-alpha) gene. The initial approved formulation available in market for arsenic trioxide is 1 mg/ml single-use 10 ml of glass ampoule (This formulation comprises 10 mg of

Risk of progressive multifocal leukoencephalopathy with Tecfidera (dimethyl fumarate): DHPC from Biogen

Biogen released a direct healthcare professional communication (DHPC) pertaining to the risk of progressive multifocal leukoencephalopathy (PML) associated with Tecfidera (dimethyl fumarate) to alert healthcare professionals for safe usage of this medicine and implementing the recommended risk minimizing measures. This DHPC released in agreement with European Medicines Agency (EMA) and national health authority of Ireland

Fingolimod induced liver injury : DHPC from Novartis

A direct health care professional communication (DHPC) released by Novartis in liaison with European medicines agency (EMA) and some of national competent authorities in Europe to disseminate important safety information pertaining to drug (fingolimod) induced liver injury to alert healthcare professionals for a careful benefit -risk analysis and early implementation of risk minimization measures for

Risk of heart valve regurgitation/incompetence with systemic and inhaled fluoroquinolones: Direct Healthcare Professional Communication

German Health Authority – Federal Institute for Drugs and Medical Devices, released a safety alert for fluoroquinolone antibiotics for the potential risk of heart valve regurgitation. This is a direct healthcare professional communication released by marketing authorisation holder of respective medicinal products in liaison with European Medicines Agency (EMA) to inform health care professionals on

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

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

Drug Safety Signals from Pharmacovigilance Risk Assessment Committee (PRAC)-EMA

Pharmacovigilance Risk Assessment Committee (PRAC), which is responsible for assessing and monitoring the safety of human medicines from European medicines agency (EMA) has published new significant safety information (signals) for medicines which were identified from their monthly PRAC meeting held during the period of 28 Sep-2020 to 01 Oct 2020. PRAC Recommendations for regulatory action

Pirfenidone induced liver injury: Drug safety alert from Norwegian Medicines Agency

Pirfenidone used in the treatment of idiopathic pulmonary fibrosis (scarring of the lung tissue). It is an inhibitor of transforming growth factor (TGF)-beta (a factor which is involved in the proliferation and differentiation of cells) and it also inhibits the TNF-Alpha. Norway health authority (Norwegian Medicines Agency) identified a new safety alert for pirfenidone from

Lack of Heparin drug efficacy due to interaction with Andexane alpha

Norwegian Medicines Agency (health authority of Norway) published a drug safety alert of drug ineffectiveness for heparin due to interaction with andexane alpha. To foster awareness, this significant safety information is disseminated to health care professionals for early implementation of risk minimizing measures. Andexanet alpha is a recombinant modified factor Xa protein for the reversal

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