Drugs Safety Labeling Updates
Drugs Safety Labeling Updates
| Scientific Name | Trade Name | Updated Section | Safety-Related Labeling Changes | Date |
|---|---|---|---|---|
| Methotrexate | Metoject | 4.6 Fertility, pregnancy and lactation | The exposure during the first trimester of pregnancy increase incidence of spontaneous abortions and multiple adverse developmental outcomes | Jul, 2025 |
| Eptinezumab | Vyepti | 4.4 Special warnings and precautions for use | Hypertension, Raynaud’s Phenomenon | Jul, 2025 |
| Pomalidomide | Imnovid | 4.8 Undesirable effect | Solid organ transplant rejection | Jul, 2025 |
| Asciminib Hydrochloride | Scemblix | 4.5 Interaction with other medicinal products and other forms of interaction | Scemblix | Jul, 2025 |
| Tacrolimus | Advagraf | 4.6 Fertility, pregnancy and lactation | Higher prevalence of spontaneous abortion | Jul, 2025 |
| Filgrastim | Nivestim | "4.4 Special warnings and precautions for use, 4.8 Undesirable effect" | Myelodysplastic syndrome (MDS) and acute myeloid leukaemia (AML) | Jul, 2025 |