Drugs Safety Labeling Updates
Drugs Safety Labeling Updates
| Scientific Name | Trade Name | Updated Section | Safety-Related Labeling Changes | Date |
|---|---|---|---|---|
| Irinotecan | Campto | 4.6 Fertility, pregnancy and lactation | Remove pregnancy category D | Mar,2023 |
| Tretinoin | Avotin | 4.3 Contraindications | Tretinoin is contraindicated during pregnancy | Mar,2023 |
| Imatinib | Imatis | 4.6 Fertility, pregnancy and lactation | Use effective contraception for at least 15 days after treatment. There have been post-marketing reports of spontaneous abortions and infant congenital anomalies from women who have taken imatinib. | Mar,2023 |
| Gefitinib | Iressa | 4.6 Fertility, pregnancy and lactation | In animal reproductive studies IRESSA can cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential to use effective contraception during treatment for at least two weeks following completion of therapy. | Mar,2023 |
| Trastuzumab | Kanjinti | 4.6 Fertility, pregnancy and lactation | In the post‑marketing setting, cases of skeletal abnormalities, and neonatal death have been reported in pregnant women receiving trastuzumab. | Mar,2023 |
| Denosumab | Proolia | 4.6 Fertility, pregnancy and lactation | Prolia is contraindicated in pregnancy because it may cause harm to a fetus. Fetal loss, stillbirths, and postnatal mortality, absent lymph nodes, abnormal bone growth, and decreased neonatal growth was reported in animal studies. | Mar,2023 |