Drugs Safety Labeling Updates
Drugs Safety Labeling Updates
| Scientific Name | Trade Name | Updated Section | Safety-Related Labeling Changes | Date |
|---|---|---|---|---|
| Dabrafenib | Tafinlar | "4.4 Special Warnings and Special Precautions for Use , 4.8 Undesirable effects" | Haemophagocytic lymphohistiocytosis | Feb,2023 |
| Regorafenib | Stivarga | "4.4 Special Warnings and Special Precautions for Use , 4.8 Undesirable effects" | Thrombotic microangiopathy | Feb,2023 |
| VORTIOXETINE | Brintellix | 4.8 Undesirable effects | Headache, hyperprolactinaemia, and hyperhidrosis | Apr,2023 |
| ERDAFITINIB | Balversa | 4.8 Undesirable effects | Electrolyte Abnormalities, Elevated liver enzymes, Gastrointestinal disorders, Fatigue, dysgeusia, musculoskeletal pain, increased creatinine, decreased albumin, and decreased hemoglobin | Apr,2023 |
| Laronidase | Aldurazyme | 4.4 Special Warnings and Special Precautions for Use, 4.8 Undesirable effects, 4.9 Overdose | Hypersensitivity reactions, IARs, Immunogenicity, Oedema peripheral, injection site pain, Warn healthcare providers about inappropiate administration leading to gastrointestinal adverse reactions, headache, dizziness, and dyspnea | Apr,2023 |
| Triptorelin | Decapeptyl | "4.4 Special Warnings and Special Precautions for Use , 4.8 Undesirable effects" | Idiopathic intracranial hypertension | Feb,2023 |