Dapagliflozin is a sodium glucose co-transporter 2 (SGLT2) inhibitor which decreases glucose level by reducing glucose reabsorption and by increasing urinary glucose excretion. Since 2012, this medicine has been indicated for the treatment of type 2 diabetes and also indicated for the treatment of below conditions in adults Symptomatic chronic heart failure with reduced ejection…
Drug Safety Communication pertaining to the safe & effective use of Beovu® (brolucizumab) released from Novartis via a direct healthcare professional communication (DHPC) letter for the implementation of updated recommendations based on the recent safety evidence from MERLIN Study (Interventional clinical trial being conducted for the comparison of Safety and Efficacy of Brolucizumab to Aflibercept…
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…
Pentosan polysulfate sodium is a semi-synthetically produced heparin which has anticoagulant and fibrinolytic effect. It is used in the treatment of bladder pain and discomfort caused by cystitis (bladder inflammation or irritation). Product information (PI) of Pentosan polysulfate sodium (‘Section 4.4 Special Warnings and Precautions for Use’ and ‘Section 4.8 Adverse Effects’) are updated with…
Propylthiouracil and Carbimazole are the medications used in the treatment of hyperthyroidism. The product information (PI) documents which were previously having status of category “C” for use in pregnant women is being updated to category “D” Category C status: Based on the mechanism of action & pharmacological activity, suspicion of causing harmful effects to the…
Product Information (PI) for Erenumab has been updated with the below statements- A warning about a potential causal relationship between the drug and hypertension under the ‘Special Warnings and Precautions’ section (Section 4.4) of the PI. Addition of hypertension under ‘Vascular disorders’ in the ‘Adverse Effects’ section (Section 4.8). Erenumab is a fully human monoclonal…
Safety update: Product Information (PI) for minocycline is in the process of being updated to include information about agranulocytosis, a rare but potentially life-threatening adverse event. Minocycline is a tetracycline antibiotic that may be used to treat acne that is resistant to other antibiotics, as well as various other susceptible infections. Agranulocytosis is a serious…
Safety update: Potential Risk of leaking heart valves (heart valve regurgitation) associated with the use of antibiotics belonging to the Fluoroquinolone class which included ciprofloxacin-, levofloxacin-, moxifloxacin- and norfloxacin-containing medicinal products which are administered by injection or by mouth (systemic) and by breathing in (inhaled). Fluoroquinolones broader spectrum antibiotics which are used in the treatment…
Safety update: Risk of acute pulmonary oedema with Nifedipine when used for the treatment of preterm labor in pregnancy: Product label update from Therapeutic Goods & Administration (TGA) – Health authority of Australia. The ‘Fertility, pregnancy and lactation’ section of the nifedipine PI (section 4.6) has been updated to include the following information: ‘Acute pulmonary…