Off-label doses of Medtronic bone product risky, study shows

A Medtronic ($MDT) bone-stimulation product recently rejected by the FDA might increase the risk of cancer, newly released study data show. Because the product, Amplify, is a higher-dose formulation of Medtronic's currently marketed Infuse, the study results could have implications for patients who received that treatment, its lead author said.

In presenting the data at a conference, Dr. Eugene Carragee of Stanford University said the trial results showed a significantly higher number of cancers in Amplify patients than in those who received a bone graft.

The worry: Amplify uses the same active ingredient as Infuse, and doctors often use the latter off-label at dosages much higher than those recommended, the New York Times reports, meaning that patients are given an amount of active ingredient as high or higher than that in Amplify.

"This information requires careful consideration because of the large number of patients receiving high doses," Carragee told the Times. The higher doses could be especially dangerous in patients genetically predisposed to develop cancer or those whose lifestyle increases cancer risks, such as smokers, he said.

Medtronic has funded an independent review of all the study data on Infuse's safety and efficacy, the Times notes. That $2.5 million review by Yale University isn't expected to be complete until next year.

- get the NYT piece