Drugs Safety Labeling Updates
Drugs Safety Labeling Updates
| Scientific Name | Trade Name | Updated Section | Safety-Related Labeling Changes | Date |
|---|---|---|---|---|
| Dasatinib | Tykodas | 4.6 Fertility, pregnancy and lactation | "Contraception in males and females for 30 days after the last dose. Based on human experience, dasatinib is suspected to cause neural tube defects on the foetus when administered during pregnancy." | Mar,2023 |
| Cetuximab | Erbitux | 4.6 Fertility, pregnancy and lactation | Females: Advise females of reproductive potential to use effective contraception during treatment with cetuximab and for 2 months after the last dose of cetuximab. Adverse evnets in animals studies | Mar,2023 |
| 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 |