Drugs Safety Labeling Updates
Drugs Safety Labeling Updates
| Scientific Name | Trade Name | Updated Section | Safety-Related Labeling Changes | Date |
|---|---|---|---|---|
| Opsutin | Macitentan | 4.6 Fertility, pregnancy and lactation | Male fertility information | Dec, 2025 |
| Lokelma | Sodium Zirconium Cyclosilicate | 4.4 special warnings and precautions for use 4.8. Undesirable effects | Worsening of pre-existing heart failure | Dec, 2025 |
| Naphcon-A | Naphazoline and Pheniramine | 4.9 Overdose | Excessive systemic exposure may lead to severe cardiovascular and/or cerebrovascular adverse reactions. | Dec, 2025 |
| Xtandi | Enzalutamide | 4.5 Interaction with other medicinal products and other forms of interaction | P-gp substrates , Laboratory Test Interference | Dec, 2025 |
| Candesartan Cilexetil, Amlodipine Besilate | Unisia | 4.4 special warnings and precautions for use, 4.8. Undesirable effects | Intestinal angioedemka , Hypertension management | Nov, 2025 |
| Leflunomide | Arava | 4.4 special warnings and precautions for use 4.8 undesirable effects 6.6 Special Precautions for Disposal and Handling | Skin ulcers , Handling Hazardous drug | Nov, 2025 |