Selective serotonin reuptake inhibitors (SSRI) and serotonin and norepinephrine reuptake inhibitors (SNRI) are antidepressant class of medications used in the treatment of depression. They act by increasing the levels of serotonin and norepinephrine in the brain for therapeutic effect. United Kingdom health authority – Medicines and Healthcare products Regulatory Agency (MHRA) released a drug safety…
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…
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,…
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…
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…
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…
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…
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…
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 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…