Drugs Safety Labeling Updates
Drugs Safety Labeling Updates
| Scientific Name | Trade Name | Updated Section | Safety-Related Labeling Changes | Date |
|---|---|---|---|---|
| Semaglutide | Rybelsus | 4.4 Special Warnings and Special Precautions for Use | Cholecystitis, cholangitis, cholestatic jaundice | Feb,2023 |
| Isoniazid; Pyrazinamide; Rifampin | Rifater | "4.4 Special Warnings and Special Precautions for Use , 4.8 Undesirable effects" | Thrombotic microangiopathy, haemolytic uremic syndrome | Feb,2023 |
| Rifampicin | Rifadin | "4.4 Special Warnings and Special Precautions for Use , 4.8 Undesirable effects" | Thrombotic microangiopathy , haemolytic uremic syndrome | Feb,2023 |
| Human Normal Immunoglobulin | Hyqvia | 4.8 Undesirable effects | Updating pediatric data in undesirable effects | Feb,2023 |
| Regorafenib | Stivarga | 4.4 Special Warnings and Special Precautions for Use | Remove disease specific warning in Hepatocellular carcinoma | Feb,2023 |
| Ruxolitinib | Jakavi | 4.4 Special Warnings and Special Precautions for Use | Major adverse cardiac events, Thrombosis, and Second primary malignancies | Jun, 2024 |