Drugs Safety Labeling Updates
Drugs Safety Labeling Updates
| Scientific Name | Trade Name | Updated Section | Safety-Related Labeling Changes | Date |
|---|---|---|---|---|
| Hydroxycarbamide | Xromi | 4.6. Fertility, pregnancy and lactation | The recommended duration of contraception in male and female patients following the end of treatment with hydroxycarbamide, should be 3 and 6 months, respectively | Jan, 2026 |
| Ceftriaxone | Samixon | 4.4 Special warnings and precautions for use 4.8. Undesirable effects | Hypersensitivity reactions Kounis syndrome | Jan, 2026 |
| Candesartan Cilexetil, Amlodipine Besilate | Unisia | 4.4 Special warnings and precautions for use 4.8. Undesirable effects | Intestinal angioedema | Jan, 2026 |
| 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 |