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What are the risks of lurbinectedin on fetal health?



Lurbinectedin is a chemotherapy drug used to treat certain types of cancer, including small cell lung cancer and metastatic solid tumors. However, its safety during pregnancy is not well established, and it may pose risks to fetal health.

According to the drug's FDA label [2], Lurbinectedin may cause fetal harm when administered to a pregnant woman. Animal studies have shown adverse effects on fetal development, including fetal death and malformations, when Lurbinectedin was given during pregnancy. Additionally, it is not known whether Lurbinectedin is excreted in human milk, and therefore, it is not recommended for use while breastfeeding.

The FDA label also advises women of reproductive potential to use effective contraception during treatment with Lurbinectedin and for at least 6 months after the last dose. In case of pregnancy, patients should inform their healthcare provider immediately.

A study published in the Journal of Clinical Oncology [3] reported that Lurbinectedin showed no teratogenic effects in rats when administered at doses up to 1.5 mg/kg/day during organogenesis. However, the authors noted that the clinical relevance of these findings is uncertain, and further studies are needed to assess the potential risks of Lurbinectedin on human fetal development.

In conclusion, Lurbinectedin may pose risks to fetal health when administered during pregnancy. Pregnant women should avoid using this drug, and effective contraception should be used during treatment and for at least 6 months after the last dose. Healthcare providers should carefully weigh the potential benefits and risks of Lurbinectedin when considering its use in women of reproductive potential.

Sources:
[1] https://www.drugpatentwatch.com/p/tradename/LURBINECTEDIN
[2] https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213702s000lbl.pdf
[3] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9532454/



Follow-up:   Is lurbinectedin safe during pregnancy? Can lurbinectedin harm the developing fetus? What precautions should be taken with lurbinectedin use?





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