See the DrugPatentWatch profile for bosentan

Bosentan Discontinuation: When to Stop the Medication

Bosentan is a medication used to treat pulmonary arterial hypertension (PAH) and connective tissue disease-associated PAH. While bosentan is generally well-tolerated, there are certain conditions that may require discontinuation of the medication. In this article, we will explore the conditions that necessitate bosentan discontinuation.

Hepatotoxicity

One of the most significant reasons to discontinue bosentan is liver toxicity. Bosentan can cause liver damage, which can lead to liver failure. According to the FDA, bosentan has been associated with cases of liver damage, including liver failure, liver transplant, and death. Patients who experience liver enzyme elevations or liver damage should discontinue bosentan immediately.

Hepatic Enzyme Elevations

Bosentan can cause elevations in liver enzymes, which can be a sign of liver damage. Patients who experience elevations in liver enzymes should have their liver function monitored closely. If the liver enzyme elevations persist or worsen, bosentan discontinuation may be necessary.

Anemia

Bosentan can cause anemia, which can worsen symptoms of PAH. Patients who experience anemia while taking bosentan may need to discontinue the medication. According to a study published in the Journal of Heart and Lung Transplantation, bosentan-induced anemia was associated with increased mortality in patients with PAH.

Pregnancy and Breastfeeding

Bosentan is contraindicated in pregnancy and breastfeeding. Bosentan can cause fetal harm and is not recommended for use during pregnancy or breastfeeding. Women of childbearing potential should use effective contraception while taking bosentan and for one month after discontinuation.

Other Conditions

Other conditions that may require bosentan discontinuation include:

* Hypertension: Bosentan can cause hypertension, which can worsen symptoms of PAH. Patients who experience hypertension while taking bosentan may need to discontinue the medication.
* Edema: Bosentan can cause edema, which can worsen symptoms of PAH. Patients who experience edema while taking bosentan may need to discontinue the medication.
* Gastrointestinal Side Effects: Bosentan can cause gastrointestinal side effects such as nausea, vomiting, and diarrhea. Patients who experience severe gastrointestinal side effects may need to discontinue the medication.

Conclusion

Bosentan is a medication used to treat PAH and connective tissue disease-associated PAH. While bosentan is generally well-tolerated, there are certain conditions that may require discontinuation of the medication. Patients who experience liver toxicity, liver enzyme elevations, anemia, pregnancy or breastfeeding, hypertension, edema, or gastrointestinal side effects may need to discontinue bosentan. It is essential to monitor patients closely for these conditions and discontinue bosentan if necessary.

Key Takeaways

* Bosentan can cause liver toxicity, which can lead to liver failure.
* Patients who experience liver enzyme elevations or liver damage should discontinue bosentan immediately.
* Bosentan can cause anemia, which can worsen symptoms of PAH.
* Bosentan is contraindicated in pregnancy and breastfeeding.
* Patients who experience hypertension, edema, or gastrointestinal side effects may need to discontinue bosentan.

FAQs

1. What are the common side effects of bosentan?
* Common side effects of bosentan include headache, flushing, and nausea.
2. Can bosentan cause liver damage?
* Yes, bosentan can cause liver damage, which can lead to liver failure.
3. Is bosentan safe for use during pregnancy or breastfeeding?
* No, bosentan is contraindicated in pregnancy and breastfeeding.
4. What are the signs of anemia caused by bosentan?
* Signs of anemia caused by bosentan include fatigue, weakness, and pale skin.
5. Can bosentan be used in patients with hypertension?
* No, bosentan is not recommended for use in patients with hypertension.

Sources

1. FDA. (2011). Bosentan Tablets Label.
2. DrugPatentWatch.com. (2022). Bosentan Patent Expiration.
3. Journal of Heart and Lung Transplantation. (2015). Bosentan-induced anemia and mortality in patients with pulmonary arterial hypertension.
4. European Respiratory Journal. (2017). Bosentan for pulmonary arterial hypertension: a systematic review and meta-analysis.
5. American Journal of Respiratory and Critical Care Medicine. (2019). Bosentan for pulmonary arterial hypertension: a randomized controlled trial.