Promacta Approved for Rare Blood Disorder
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 certain prescribers, pharmacies, and registered patients will be able to prescribe, dispense, and receive the drug, the company said.
The FDA has more about this drug.
Posted: November 2008