FDA Calls Out Amgen Over Misleading Anemia Drug Claims

Law360, New York (November 22, 2013, 5:05 PM EST) -- Direct mailers from Amgen Inc. oversold the benefits of anemia drug Aranesp and omitted important information about its potential to cause heart attacks and strokes, according to a U.S. Food and Drug Administration letter released Friday.

In a so-called untitled letter, which addresses less serious violations than FDA warning letters, regulators accused California-based Amgen of presenting an incomplete portrait of risks in a four-page document.

While many of the drug’s possible side effects were listed, there was an absence of references to increased potential for deaths,...
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