Scientific Name | Trade Name | Updated Section | Safety-Related Labeling Changes | Date |
---|---|---|---|---|
Dabigatran Etexilate Mesylate | Pradaxa | 4.8 Undesirable effects | Multiple safety updates including: Anticoagulant-related nephropathy | Nov,2023 |
Voriconazole | Vfend | 4.8 Undesirable effects | Phototoxicity and Periostitis (Update the frequency) | Nov,2023 |
Larotrectinib | Vitrakvi | 4.8 Undesirable effects | Hepatotoxicity | Nov,2023 |
Ibrutinib | Imbruvica | 4.8 Undesirable effects | Pyogenic granuloma and Acute kidney injury | Nov,2023 |
Tadalafil | Cialis | 4.4 Special Warnings and Special Precautions for Use | Central Serous Chorioretinopathy | Nov,2023 |
Paroxetine | Seroxat | 4.8 Undesirable effects | Leukopenia | Oct,2023 |