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FDA Sends Letter to Amgen Inc. Critical of Direct Mailer that Downplays Drug’s Risks

Filed November 25th, 2013 edlieber1

 

The U.S. Food and Drug Administration (FDA) issued a letter to Amgen Inc. that is critical of a direct mailer written to support the company’s Aranesp anemia drug but that fails to mention the drug’s potential links to heart attacks and strokes.

The FDA letter accuses Amgen of presenting an incomplete picture of the drug’s risks. While many of Aranesp’s side effects were listed, no references were made to the increased potential for deaths, heart attacks, strokes, blood clots, reduced hemoglobin levels, and a red blood cell disorder, according to Law360.com.

“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 letter said.

The FDA wrote that Amgen’s oversimplifications could lead patients to believe that Aranesp is safe to use in more than just the narrowly defined population of patients with chemotherapy-induced anemia for which Aranesp was approved, according to Law360.com.

The letter states that the pamphlet creates “the overwhelming impression that Aranesp is useful in a much broader range of patients than has been demonstrated by substantial evidence or substantial clinical experience,” Law360.com reported.

Amgen wrote in the mailer that Aranesp can deliver a “gradual and steady” rise in hemoglobin levels and cited studies to support its claim, but the FDA said in its letter that the scientific literature doesn’t support that claim, according to Law360.com.

The FDA also said the company went too far when it speculated about how many patients could expect to avoid blood transfusions if they use Aranesp. The mailer also failed to supply enough specifics on appropriate dosing, Law360.com wrote.

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