New Indication for Promacta in Children
August 24, 2015 – The U.S. Food and Drug Administration (FDA) approved GlaxoSmithKline’s Promacta (eltrombopag) for treating children as young as one year old who suffer from chronic immune thrombocytopenia (ITP) that have not responded to prior treatment with corticosteroids, immunoglobulins or spleen removal. A new oral suspension formulation was also approved. Promacta was originally approved as tablets in November 2008 for adults and June 2015 for children age six and older. Patients with ITP make smaller than normal amounts of platelets, therefore they are likely to bleed and bruise easily. ITP may cause bleeding gums, nose bleeds, petechiae, and purpuras. The Platelet Disorders Support Association estimates about five children and about nine adults out of every 100,000 have ITP. Recommended dosing for children between one and six years old is 25mg once a day.
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- 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.