Promacta Approved for Use in Children
Promacta® (eltrombopag) which is manufactured by Novartis has been approved by the U.S. Food and Drug Administration (FDA) for another indication. Promacta is now indicated to treat children six years of age and older with chronic immune thrombocytopenia (cITP) who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy. Promacta is a thrombopoietin receptor agonist that first gained FDA approval in 2008 for use in adult patients with cITP. It has since been indicated for the treatment of thrombocytopenia (low blood platelet counts) in patients with chronic hepatitis C to allow them to initiate and maintain interferon-based therapy, and to treat severe aplastic anemia.
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 regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular 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
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*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.