Drugs Safety Labeling Updates
Drugs Safety Labeling Updates
| Scientific Name | Trade Name | Updated Section | Safety-Related Labeling Changes | Date |
|---|---|---|---|---|
| Tisagenlecleucel | Kymriah | 4.4 Special Warnings and Special Precautions for Use | Risk of T cell malignancies | Dec, 2024 |
| Binmetinib | Mektovi | 4.8 Undesirable effects | Hyponatremia | Dec, 2024 |
| Somatropin | Genotropin | 4.8 Undesirable effects | Headache and pruritus | Nov,2024 |
| 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 |