New Pediatric Indication for Tracleer
September 6, 2017 – The U.S. FDA has approved Tracleer® (bosentan), manufactured by Actelion Pharmaceuticals, for treatment of patients as young as three years old who have idiopathic or congenital pulmonary arterial hypertension (PAH). PAH is a form of high blood pressure that occurs in the arteries running between the heart and lungs; the life-threatening, chronic disease worsens over time, damaging the arteries and causing the heart to beat harder than normal.
An oral endothelin receptor antagonist, Tracleer has a recommended dosing of twice per day. The total daily dosage is determined by body weight. New 32mg Tracleer tablets can be readily divided to provide the proper dose for pediatric patients, and can be dissolved in a teaspoon of water for easy administration. The larger 62.5mg and 125mg film-coated tablets will still be available for adult patients.
Tracleer carries a black box warning cautioning that the drug may cause liver damage and severe birth defects. Due to these potential side effects, Tracleer is available only through a risk evaluation and mitigation strategy (REMS); patients, pharmacies, and prescribers must be enrolled in the program in order for Tracleer to be dispensed.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.