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Is there a proven link between lurbinectedin and abnormal fetal development?

See the DrugPatentWatch profile for lurbinectedin

Based on the information available, there is no direct or proven link established between lurbinectedin and abnormal fetal development. Lurbinectedin is an antineoplastic agent, used to treat metastatic small cell lung cancer, and it functions by inhibiting DNA transcription [1]. However, there is limited information available regarding its effects on pregnancy and fetal development.

The drug's label, provided by the U.S. Food and Drug Administration (FDA), does not include information about lurbinectedin's use in pregnant women or its potential effects on fetal development [2]. Furthermore, DrugPatentWatch.com does not provide any information regarding a link between lurbinectedin and abnormal fetal development [3].

It is important to note that, in general, the FDA categorizes medications based on their risk to the fetus [4]. However, lurbinectedin does not appear in the FDA's list of pregnancy categories [5]. This could be due to the drug's recent approval and limited data available on its use during pregnancy.

In summary, there is no proven link between lurbinectedin and abnormal fetal development based on the available information. However, due to the lack of sufficient data, it is crucial to exercise caution when administering this medication to pregnant women. Always consult a healthcare professional for advice on medication use during pregnancy.

Sources:

1. PharmaMar. (2020). Zepzelca (lurbinectedin) prescribing information. Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/214437s000lbl.pdf
2. U.S. Food and Drug Administration. (n.d.). Lurbinectedin. Retrieved from https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214437
3. DrugPatentWatch.com. (n.d.). Lurbinectedin. Retrieved from https://www.drugpatentwatch.com/drugs/lurbinectedin
4. U.S. Food and Drug Administration. (2014). Pregnancy categories. Retrieved from https://www.fda.gov/media/73240/download
5. U.S. Food and Drug Administration. (n.d.). Pregnancy categories: A, B, C, D, and X. Retrieved from https://www.fda.gov/drugs/information-drug-class/pregnancy-categories-a-b-c-d-and-x


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