Drugs Safety Labeling Updates
Drugs Safety Labeling Updates
| Scientific Name | Trade Name | Updated Section | Safety-Related Labeling Changes | Date |
|---|---|---|---|---|
| Ustekinumab | Stelara | 4.4 Special Warnings and Special Precautions for Use | Inclusion of cardiovascular risk based on PSOLAR study observations | Apr,2023 |
| Carbetocin | Pabal Rts | 4.8 Undesirable effects | Bradycardia, hypersensitivity | Apr,2023 |
| Darunavir | Prezista | 4.8 Undesirable effects | Crystal nephropathy, crystalluria, redistribution of fat | Apr,2023 |
| Atorvastatin | Tovast | "4.4 Special Warnings and Special Precautions for Use , 4.8 Undesirable effects" | Myasthenia gravis and Ocular myasthenia | Feb,2023 |
| Upadacitinib | Rinvoq | 4.4 Special Warnings and Special Precautions for Use | Updated recommendations to minimise the risks of malignancy, major adverse cardiovascular events, serious infections, Venous thromboembolism and mortality with use of Janus kinase inhibitors | Apr,2023 |
| Dabrafenib | Tafinlar | "4.4 Special Warnings and Special Precautions for Use , 4.8 Undesirable effects" | Haemophagocytic lymphohistiocytosis | Feb,2023 |