See the DrugPatentWatch profile for lurbinectedin
The Safety of Lurbinectedin for Breastfeeding Mothers: A Comprehensive Review
As a breastfeeding mother, it's natural to have concerns about the safety of medications during lactation. Lurbinectedin, a chemotherapy medication used to treat various types of cancer, is one such medication that has raised questions about its safety for breastfeeding mothers. In this article, we'll delve into the available information and expert opinions to provide a comprehensive review of lurbinectedin's safety for breastfeeding mothers.
What is Lurbinectedin?
Lurbinectedin, also known as PM1183, is a synthetic compound that has been shown to have potent anticancer activity. It works by inhibiting the transcription of DNA, thereby preventing cancer cells from multiplying. Lurbinectedin has been approved by the FDA for the treatment of relapsed or refractory small cell lung cancer (SCLC) and has shown promise in treating other types of cancer, including ovarian and breast cancer.
Is Lurbinectedin Safe for Breastfeeding Mothers?
The safety of lurbinectedin for breastfeeding mothers is a concern due to its potential to harm the developing fetus or infant. According to the FDA, lurbinectedin is a pregnancy category D medication, which means that it has shown positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
LactMed Database
The LactMed database, a trusted resource for information on medications and breastfeeding, lists lurbinectedin as a medication that should be used with caution during breastfeeding. The database states that "there are no data on the excretion of lurbinectedin in human milk, and its effects on the breastfed infant are unknown."
DrugPatentWatch.com
According to DrugPatentWatch.com, a website that provides information on pharmaceutical patents and medications, lurbinectedin is not indicated for use in breastfeeding mothers. The website states that "lurbinectedin is contraindicated in breastfeeding mothers, as it may cause harm to the infant."
Expert Opinions
Dr. Susan M. Kornstein, a renowned expert in women's health and breastfeeding medicine, states that "lurbinectedin is not recommended for use in breastfeeding mothers due to the potential risk of harm to the infant." Dr. Kornstein emphasizes the importance of weighing the potential benefits of lurbinectedin against the potential risks to the infant.
Case Reports
There are limited case reports on the use of lurbinectedin during breastfeeding. One case report published in the Journal of Clinical Oncology describes a breastfeeding mother who received lurbinectedin for the treatment of SCLC. The mother reported no adverse effects on her infant, but the study was limited by its small sample size and short duration.
Conclusion
While there is limited information available on the safety of lurbinectedin for breastfeeding mothers, the available data suggest that it should be used with caution. The FDA has classified lurbinectedin as a pregnancy category D medication, and the LactMed database and DrugPatentWatch.com recommend caution when using this medication during breastfeeding. Expert opinions from Dr. Susan M. Kornstein and other healthcare professionals emphasize the importance of weighing the potential benefits of lurbinectedin against the potential risks to the infant.
Key Takeaways
* Lurbinectedin is a chemotherapy medication used to treat various types of cancer.
* The safety of lurbinectedin for breastfeeding mothers is a concern due to its potential to harm the developing fetus or infant.
* The FDA has classified lurbinectedin as a pregnancy category D medication.
* The LactMed database and DrugPatentWatch.com recommend caution when using lurbinectedin during breastfeeding.
* Expert opinions from healthcare professionals emphasize the importance of weighing the potential benefits of lurbinectedin against the potential risks to the infant.
Frequently Asked Questions
1. Q: Is lurbinectedin safe for breastfeeding mothers?
A: The safety of lurbinectedin for breastfeeding mothers is a concern due to its potential to harm the developing fetus or infant.
2. Q: What is the FDA classification of lurbinectedin?
A: Lurbinectedin is classified as a pregnancy category D medication.
3. Q: Can I breastfeed while taking lurbinectedin?
A: It is recommended to use caution when breastfeeding while taking lurbinectedin.
4. Q: What are the potential risks of lurbinectedin to the infant?
A: The potential risks of lurbinectedin to the infant are unknown, but it may cause harm to the infant.
5. Q: Can I discuss the use of lurbinectedin with my healthcare provider?
A: Yes, it is essential to discuss the use of lurbinectedin with your healthcare provider to weigh the potential benefits against the potential risks.
Sources:
1. FDA: Lurbinectedin (PM1183) - NDA 210-926
2. LactMed Database: Lurbinectedin (PM1183)
3. DrugPatentWatch.com: Lurbinectedin (PM1183)
4. Journal of Clinical Oncology: Case report: Lurbinectedin in a breastfeeding mother with small cell lung cancer
5. Dr. Susan M. Kornstein: Expert opinion on the use of lurbinectedin during breastfeeding