Drugs Safety Labeling Updates
Drugs Safety Labeling Updates
| Scientific Name | Trade Name | Updated Section | Safety-Related Labeling Changes | Date |
|---|---|---|---|---|
| Daunorubicin,Cytarabine | Vyxeos | "4.4 Special warnings and precautions for use 4.6 Fertility, pregnancy and lactation" | "Cardiotoxicity Women of childbearing potential/Contraception in males and females" | Jun, 2025 |
| Mycophenolate Sodium | Resepta | "4.4 Special warnings and precautions for use 4.8 Undesirable effects 4.7 Effects on ability to drive and use machines" | "Sodium content ,Infections, Blood and lymphatic disorder , gastrointestinal disorder , Respiratory, thoracic and mediastinal disorders General disorders and administration site conditions, and updates in Summary of safety profile Mycophenolate Mofetil has a moderate influence on the ability to drive and use machines" | Jun, 2025 |
| Rsv subgroup a stabilised prefusion f,rsv subgroup b stabilised prefusion f | Abrysvo | 4.5 Interaction with other medicinal products and other forms of interaction | Abrysvo can be administered concomitantly with COVID-19 mRNA vaccine, with or without high dose of influenza vaccine administered concomitantly | May,2025 |
| Andexanet alfa | Andexxa | "4.4 Special warnings and precautions for use 4.5 Interaction with other medicinal products and other forms of interaction 4.8 Undesirable effect" | Thromboembolic and ischemic risks, unresponsiveness to heparin | May,2025 |
| Berotralstat | Orladeyo | 4.8 Undesirable effect | Nausea | May,2025 |
| Diphenhydramine hydrochloride,dextromethorphan hydrobromide,pseudoephedrine hydrochloride | Mentex | 4.4 Special warnings and precautions for use | Posterior Reversible Encephalopathy Syndrome (PRES) | May,2025 |