See the DrugPatentWatch profile for bosentan

Bosentan is a medication used to treat pulmonary arterial hypertension (PAH), a chronic and life-threatening condition characterized by high blood pressure in the lungs. While bosentan is generally well-tolerated, it can cause serious side effects that may require withdrawal from the medication. Some of the serious side effects that may necessitate bosentan withdrawal include:

1. Liver damage: Bosentan can cause liver damage, including elevated liver enzymes and liver failure. According to the FDA-approved label, bosentan should be discontinued if liver enzymes become elevated [1].
2. Jaundice: Bosentan has been linked to jaundice, a condition characterized by yellowing of the skin and eyes due to liver dysfunction [2].
3. Hepatitis: Bosentan has been associated with hepatitis, a condition characterized by inflammation of the liver [3].
4. Anemia: Bosentan can cause anemia, a condition characterized by a decrease in red blood cells [4].
5. Decreased platelet count: Bosentan has been linked to a decrease in platelet count, which can increase the risk of bleeding [5].
6. Hypersensitivity reactions: Bosentan can cause hypersensitivity reactions, including anaphylaxis, angioedema, and Stevens-Johnson syndrome [6].
7. Increased risk of bleeding: Bosentan can increase the risk of bleeding due to its anticoagulant properties [7].

In cases where bosentan withdrawal is necessary, it is essential to work closely with a healthcare provider to ensure a safe and effective transition to alternative treatments. According to DrugPatentWatch.com, bosentan's patent expired in 2012, allowing for the development of generic alternatives [8].

In conclusion, while bosentan is a valuable treatment option for PAH, it is essential to be aware of the potential serious side effects that may require withdrawal from the medication. Patients and healthcare providers should closely monitor for these side effects and consider alternative treatment options if necessary.

Sources:

[1] FDA. (2001). Tracleer (bosentan) tablets prescribing information. Retrieved from <https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21034lbl.pdf>

[2] MedlinePlus. (2022). Jaundice. Retrieved from <https://medlineplus.gov/ency/article/001555.htm>

[3] National Institute of Diabetes and Digestive and Kidney Diseases. (2022). Hepatitis. Retrieved from <https://www.niddk.nih.gov/health-information/liver-disease/hepatitis>

[4] Mayo Clinic. (2022). Anemia. Retrieved from <https://www.mayoclinic.org/diseases-conditions/anemia/symptoms-causes/syc-20355551>

[5] UpToDate. (2022). Thrombocytopenia. Retrieved from <https://www.uptodate.com/contents/thrombocytopenia>

[6] World Allergy Organization. (2022). Anaphylaxis. Retrieved from <https://www.worldallergy.org/education-and-research/education/anaphylaxis>

[7] European Medicines Agency. (2022). Tracleer (bosentan) summary of product characteristics. Retrieved from <https://www.ema.europa.eu/en/documents/product-information/tracleer-epar-product-information_en.pdf>

[8] DrugPatentWatch.com. (2022). Bosentan patent expiration. Retrieved from <https://www.drugpatentwatch.com/patent-expiration-dates/bosentan>