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Idiopathic (Immune) Thrombocytopenic Purpura Blog

Related terms: Immune Thrombocytopenic Purpura, ITP

Promacta Approved for Rare Blood Disorder

Posted 24 Nov 2008 by Drugs.com

MONDAY, Nov. 24 – The U.S. Food and Drug Administration has approved Promacta (eltrombopag) to treat a rare condition in which the body attacks its own blood platelets. Chronic immune thrombocytopenic purpura (ITP) affects about 60,000 people in the United States, according to a news release from the drug's maker, GlaxoSmithKline. ITP patients often bleed from small blood vessels, resulting in bruising, nosebleeds and in rare cases, bleeding from the brain. The drug's labeling will include the FDA's most serious advisory, a so-called "black-box warning," highlighting Promacta's risk of damaging the liver. According to the Associated Press, the FDA delayed an approval decision on Promacta in June, citing the drug's liver toxicity. People taking Promacta must have regular serum liver tests, Glaxo said. Promacta will be available through a restricted distribution program, in which only ... Read more

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Bone Marrow Treatment Approved for Rare Bleeding Disorder

Posted 22 Aug 2008 by Drugs.com

FRIDAY, Aug. 22 – The U.S. Food and Drug Administration has approved Nplate (romiplostim), a drug that stimulates bone marrow to make needed platelets in people with a rare bleeding disorder called immune thrombocytopenic purpura (ITP). The disorder, affecting about 140,000 people in the United States, causes a low count of platelets, a component that helps blood clot. In people with chronic ITP, it's believed the body's own immune system destroys platelets, and the bone marrow is unable to produce enough platelets to compensate. People with ITP tend to bruise easily and are at risk for life-threatening bleeding, the FDA said in a news release. During six months of clinical testing involving 125 people with ITP, those who received Nplate had significantly higher platelet counts than those who didn't get the drug, the agency said. Possible risks from taking the drug include fibrous ... Read more

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