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Two Drugs, One Possible Issue

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The US Food and Drug Administration rejected Medtronic's bone-growth product Amplify back in March, due to cancer risk concerns. Amplify is a higher-dose version of the company's Infuse product. At a conference this week, Stanford University's Eugene Carragee said that not all of Medtronic's clinical trial data had been made public before, and that data "showed a significantly higher number of cancers in the study group that received Amplify when compared to a control group that received a bone graft as part of a spinal fusion," The New York Times reports. Carragee added that the Amplify results may also be of importance for Infuse, as the products have the same active ingredient and as some doctors prescribe Infuse at high doses, closer to those seen in Amplify.

In August, Medtronic awarded Yale University $2.5 million to review Infuse study data. That review is expected to be finished next year, and a spokesperson tells the Times that that review "will address the safety and effectiveness" of Infuse.

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