Drugs Safety Labeling Updates
Drugs Safety Labeling Updates
| Scientific Name | Trade Name | Updated Section | Safety-Related Labeling Changes | Date |
|---|---|---|---|---|
| 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 |
| Glatiramer acetate | Galtipex | 4.4 special warnings and precautions for use | Medication errors have occurred when glatiramer acetate products are administered with incompatible autoinjectors | Sep, 2025 |
| Salbutamol | Ventolin | 4.4 special warnings and precautions for use | Overuse of short-acting beta-agonists may mask the progression of the underlying disease | Sep, 2025 |
| Olmesartan medoxomil,amlodipine besilate | Sevikar | 4.4 special warnings and precautions for use 4.8. Undesirable effects | Intestinal angioedema | Sep, 2025 |
| Cariprazine hydrochloride | Reagila | 4.5. Interaction with other medicinal products and other forms of interaction | Strong or moderate CYP 3A4 inhibitors, and CYP 3A4 inducers | Sep, 2025 |