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Old Thu Oct 6, 2011, 09:33 AM
Neil Cuadra Neil Cuadra is offline
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Join Date: Jul 2006
Location: Los Angeles, California
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The warning is a strong statement that Nplate should not be given to MDS patients because of an increased risk of transition to AML, especially for the higher risk MDS categories. It was also a warning about the risk of increased blasts if Nplate is given to MDS patients, after a study found that 4 times as many MDS patients had increased blasts as a placebo group.

To quote:
A positive benefit/risk for Nplate is only established for the treatment of thrombocytopenia associated with chronic immune (idiopathic) thrombocytopenic purpura (ITP), Nplate must not be used in other clinical conditions associated with thrombocytopenia.

The diagnosis of MDS must be excluded.
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