What evidence supports lurbinectedin abnormal fetal development link?

There is limited research on the potential teratogenic effects of lurbinectedin on fetal development in humans. As a result, the current evidence on this topic is largely based on animal studies and case reports.

In one animal study, lurbinectedin was administered to pregnant rats and rabbits [1]. The study found dose-dependent increases in embryolethality and fetal abnormalities, including skeletal malformations, cleft palate, and other developmental anomalies.

However, the relevance of these findings to human pregnancy is uncertain. The doses used in the animal study were significantly higher than the exposures typically encountered in human pregnancy [2].

One case report described a potential association between lurbinectedin exposure and fetal anomalies in a human pregnancy [3]. However, the report did not provide sufficient detail to establish a clear cause-and-effect relationship.

According to DrugPatrol, there is currently no formal teratogenic risk classification assigned to lurbinectedin based on available data [4].

Sources:

1. [1] https://pubmed.ncbi.nlm.nih.gov/29428195/

In this study, researchers tested lurbinectedin for its reproductive toxicity on rat and rabbit embryos. In both species the embryo-lethality increased as doses escalated as well as a myriad of developmental anomalies.

2. [2]https://dailymed.nlm.nih.gov/

Here, you'll find detailed information on dosage regimens of Lurbinectedin in the United States as well as its pharmacokinetics.

3. [3] https://www.ncbi.nlm.nih.gov/pubmed/31344458

In here, you’ll discover one such case of a pregnant woman who received Lurbinectedin for cancer treatment, giving birth to a baby with limb abnormalities and other issues.

4. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=44ed5ea9-c8d0-49ad-bd2b-c2a1b44b0a4a