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FDA Medical Bulletin * Summer 1997 * Volume 27 Number
2
NEW TREATMENT FOR ORPHAN
DISEASE,
ESSENTIAL THROMBOCYTHEMIA
FDA has approved anagrelide hydrochloride for the treatment of
essential thrombocythemia to reduce the elevated platelet count and
the risk of thrombosis and ameliorate associated symptoms. Other
therapy used in the past for this disease is potentially
carcinogenic or can cause serious side effects by decreasing white
blood cell or red blood cell counts; anagrelide affects only
platelet count. Over the course of three clinical trials, 551
essential thrombocythemia patients were treated with anagrelide
hydrochloride, and the most frequently reported side effects
included headache, palpitations, diarrhea, and abdominal pain.
These side effects were mild, self-limiting, and dose-related. More
than 2,300 patients have received the drug under a compassionate
use protocol.
Roberts Pharmaceutical Corp., based in Eatontown, NJ, is marketing
anagrelide hydrochloride under the trade name Agrylin.
REPORT SERIOUS ADVERSE EVENTS AND PRODUCT PROBLEMS TO
MEDWATCH
1-800-FDA-1088
FDA/Website Management Staff