Pholcodine is an opioid medicine widely present in many over-the-counter cough syrups, for its antitussive activity. Pholcodine is in market since 1950s and the products containing pholcodine are approved for the following conditions: Treatment of dry cough (non-productive) in adults and children older than 6 years of age. Treatment of symptoms of cold and influenza…
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…
Safety Alert: Serious risk of respiratory depression associated with the use of pregabalin even without concomitant use of opioid medications or other CNS depressants. Health Authority: Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) Pregabalin-containing medicinal products are marketed under various brand names for the treatment of following conditions: Generalized anxiety disorder…
European Medicines Agency (EMA) released a direct health care professional letter (DHPC) pertaining to the risk of drug-induced liver injury (DILI) by metamizole. We encourage all health care professionals to be aware of this new safety alert and to disseminate this significant information to the relevant stakeholders for a better patient safety. Metamizole (also known…
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…
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…