Drugs Safety Labeling Updates
Drugs Safety Labeling Updates
| Scientific Name | Trade Name | Updated Section | Safety-Related Labeling Changes | Date |
|---|---|---|---|---|
| Vandetanib | Caprelsa | 4.4 special warnings and precautions for use 4.8. Undesirable effects | Osteonecrosis | Oct, 2025 |
| Hydroxychloroquine Sulphate | Plaquenil | 4.4 special warnings and precautions for use | Reactivation of infections | Oct, 2025 |
| Meropenem; Vaborbactam | Vabomere | 4.4 special warnings and precautions for use 4.8. Undesirable effects | Rhabdomyolysis | Oct, 2025 |
| Vortioxetine | Brintellix | 4.8. Undesirable effects | Hallucinations | Oct, 2025 |
| Obeticholic Acid | Ocaliva | 4.4 special warnings and precautions for use 4.8. Undesirable effects | Contraindicated in Patients with decompensated cirrhosis (e.g., Child-Pugh Class B or C) or a prior decompensation. Hepatic adverse events | Oct, 2025 |
| Amisulpride | Solian | "4.4 special warnings and precautions for use 4.8. Undesirable effects" | Rhabdomyolysis. Blood creatine phosphokinase increased | Oct, 2025 |