Drugs Safety Labeling Updates
Drugs Safety Labeling Updates
| Scientific Name | Trade Name | Updated Section | Safety-Related Labeling Changes | Date |
|---|---|---|---|---|
| Phenytoin Sodium | Epanutin | 4.4 Special Warnings and Special Precautions for Use | Serious Skin Reactions | Dec, 2024 |
| Ibuprofen | Ibucare | 4.3 Contraindications. 4.6 Pregnancy, lactation and fertility | Contraindicated in third trimester of pregnancy. Updated safety information for use during pregnancy | Nov,2024 |
| Ponesimod | Ponvory | 4.5. Interactions with other medicinal products | No dose adjustment is needed when ponesimod is co-administered with strong CYP3A4 and UGT1A1 inducers | Dec, 2024 |
| Tolterodine | Detrusitol | 4.4 Special warnings and precautions for use. 4.5 Interactions with other medicinal products | Use in Patients with congenital or acquired QT prolongation. Interactions with Potent CYP2D6 Inhibitors and Potent CYP3A4 Inhibitors | Nov,2024 |
| Pantoprazole | Pantozol | 4.8 Undesirable effect | Rhabdomyolysis | Nov,2024 |
| Alprostadil | Caverject | 4.6 Pregnancy, lactation and fertility | Safety information related to fertility | Nov,2024 |