Xarelto Denied Expanded Approval by FDA

Xarelto, which has been introduced along with Pradaxa as the next generation of blood thinner medications in recent years, has been denied by federal regulators as a means to prevent life-threatening blood clots.

Johnson & Johnson, the maker of Xarelto, had previously requested that the Food and Drug Administration (FDA) consider expanding the approval of the drug so it could act as a preventative measure against blood clots in patients who have been diagnosed with acute coronary artery disease.

However, the pharma manufacturer announced on June 21 that the FDA had denied the expanded approval request. The administration’s decision came one month after an FDA panel also voted against expanding the drugs approval because too much information was missing from J&J studies.

The panel also was concerned about dangerous bleeding episodes that were associated with the drug, the Associated Press reported.

Much like Xarelto, Pradaxa has been the focus of much scrutiny since it was approved by the FDA in October 2010. If you or a loved one has been harmed by a dangerous drug like Pradaxa, call Sokolove Law today to learn more about what is required to pursue a Pradaxa lawsuit. For legal help, call (800) 581-6358.

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