Drugs Safety Labeling Updates
Drugs Safety Labeling Updates
| Scientific Name | Trade Name | Updated Section | Safety-Related Labeling Changes | Date |
|---|---|---|---|---|
| Risankizumab | Skyrizi | 4.6 Fertility, pregnancy and lactation | IgG antibodies across the placenta | May,2025 |
| Gemcitabine | Gemzar | 4.8 Undesirable effect | Sepsis (Rare), Thrombotic microangiopathy (very rare) | May,2025 |
| Enoxaparin sodium | Inhixa | 4.4 Special warnings and precautions for use | Monitoring of platelet counts, Acute generalized exanthematous pustulosis | May,2025 |
| Tetracosactide | Synacthen depot | "4.4 Special warnings and precautions for use 4.8 Undesirable effect" | Pheochromocytoma crisis | May,2025 |
| RSV Subgroup A Stabilised Prefusion F,RSV Subgroup B Stabilised Prefusion F | Abrysvo | 4.5 Interaction with other medicinal products and other forms of interaction | Abrysvo can be administered concomitantly with COVID-19 mRNA vaccine, with or without high dose of influenza vaccine administered concomitantly | Apr, 2025 |
| Orladeyo | Berotralstat | 4.8 Undesirable effect | Nausea | Apr, 2025 |