Drugs Safety Labeling Updates
Drugs Safety Labeling Updates
| Scientific Name | Trade Name | Updated Section | Safety-Related Labeling Changes | Date |
|---|---|---|---|---|
| Rivaroxaban | Xarelto | 4.8 Undesirable effects | Anticoagulantrelated nephropathy | Aug, 2024 |
| Lanadelumab | Takhzyro | 4.8 Undesirable effects | Addition of Long-term safety data based on HELP study extension | Jul, 2024 |
| Valganciclovir | Valgan | "4.2 Posology and method of administration 6.6 Special precautions for disposal and other handling" | "SFDA requested SPC/ PIL update to all registered hazardous medications to add the proposed language regarding safe handling and disposal of hazardous medications in order to ensure safety of patients, healthcare professionals, and family caregivers. " | Jul, 2024 |
| Faricimab | Vabysmo | "4.4 Special Warnings and Special Precautions for Use 4.8 Undesirable effects" | Multiple safety updates including; retinal Vasculitis and/or Retinal Vascular Occlusion | Jul, 2024 |
| Apalutamide | Erleada | "4.4 Special Warnings and Special Precautions for Use 4.8 Undesirable effects" | Multiple safety updates including; Interstitial Lung Disease and restless legs syndrome | Jul, 2024 |
| Paliperidone | Invega | 4.8 Undesirable effects | Multiple safety updates including; Hyponatremia | Jul, 2024 |