Drugs Safety Labeling Updates
Drugs Safety Labeling Updates
| Scientific Name | Trade Name | Updated Section | Safety-Related Labeling Changes | Date |
|---|---|---|---|---|
| Paclitaxel | Anzatax | 4.6 Fertility, pregnancy and lactation | Remove pregnancy category D | Mar,2023 |
| Busulfan | Myleran | 4.6 Fertility, pregnancy and lactation | Busulfan is contraindicated during pregnancy, use effective contraception during and up to 6 months after treatment in male and female | Mar,2023 |
| Bleomycin | Bleomycin Venus | 4.4 Special Warnings and Special Precautions for Use | Acute myeloid leukaemia/myelodysplastic syndrome | Jan,2023 |
| Thiotepa | Tiplex | 4.6 Fertility, pregnancy and lactation | Contraception in males and females. Fertility :As most alkylating agents, thiotepa might impair male and female fertility. | Mar,2023 |
| Sorafenib Tosylate | Nexavar | 4.6 Fertility, pregnancy and lactation | Contraception in males and females | Mar,2023 |
| Lapatinib | Tykerb | 4.8 Undesirable effects | Addition of skin fissures to the list of undesirable effects | Jul, 2024 |