Drugs Safety Labeling Updates
Drugs Safety Labeling Updates
| Scientific Name | Trade Name | Updated Section | Safety-Related Labeling Changes | Date |
|---|---|---|---|---|
| Naphazoline and Pheniramine | Naphcon-A | 4.9 Overdose | Excessive systemic exposure may lead to severe cardiovascular and/or cerebrovascular adverse reactions. | Dec, 2025 |
| Macitentan | Opsutin | 4.6 Fertility, pregnancy and lactation | Male fertility information | Dec, 2025 |
| Sodium Zirconium Cyclosilicate | Lokelma | 4.4 special warnings and precautions for use 4.8. Undesirable effects | Worsening of pre-existing heart failure | Dec, 2025 |
| Enzalutamide | Xtandi | 4.5 Interaction with other medicinal products and other forms of interaction | P-gp substrates , Laboratory Test Interference | Dec, 2025 |
| Opsutin | Macitentan | 4.6 Fertility, pregnancy and lactation | Male fertility information | 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 |