FDA Criticizes Amgen Over Misleading Marketing Claims for Anemia DrugNov 26, 2013
According to a letter released on Friday by the U.S. Food and Drug Administration (FDA), a direct mail promotional effort by Amgen Inc. oversold the benefits of the anemia drug Aranesp and omitted important information about its potential to cause heart attacks and strokes.
The “untitled letter”—an FDA communication that addresses less serious violations than an FDA warning letter—accused Amgen of presenting an incomplete portrait of its drug’s risks in a four-page document, according to Law360. Aranesp (darbepoetin alfa) is prescribed to treat anemia caused by kidney failure or chemotherapy.
According to the FDA letter, Amgen’s literature did not include references to increased potential for deaths, heart attacks, strokes, blood clots, reduced hemoglobin levels, and a red blood cell disorder. “The omission of this important risk information regarding multiple warnings and precautions for Aranesp misleadingly suggests that the drug is safer than has been demonstrated,” the FDA letter said. Amgen’s materials did not specifically mention those adverse events in the brochure, instead directing readers to separately provided prescribing information and to the Aranesp website, according to Law360. But the FDA said this does not mitigate the omission of the information in the direct mailer itself.
The FDA also wrote that Amgen oversimplified information in several areas, which could lead readers to believe that Aranesp is appropriate to use in more than the narrowly defined population of patients for which the product is approved, according to Law360. Amgen wrote that Aranesp can deliver a “gradual and steady” rise in hemoglobin levels and cited studies to support its claim, but the FDA said the scientific literature doesn’t actually offer evidence of the purported benefit. In addition, the agency said Amgen went too far in its claims for how many patients could expect to avoid blood transfusions if they use Aranesp, and the company failed to supply enough specifics on appropriate dosing.
Amgen didn’t immediately respond to a request for comment Friday, Law360 reports.