Researcher Urges FDA Caution on New Anti-Clotting Drug

An anti-clotting drug now under development by Eli Lilly & Co. and Daiichi Sankyo Co. may cause life-threatening internal bleeding, so the Food and Drug Administration should consider lowering the recommended dose, according to a researcher who reviewed the drug.

The FDA is now considering whether to approve prasugrel, which has been proposed as a 10-milligram dose. However, Johns Hopkins University physician Victor Serebruany said that the proposed dose could result in excess bleeding. He wants the FDA to stop reviewing prasugrel and test the drug as a five-milligram dose. A lower dose of the drug might result in a lower risk of internal bleeding, Serebruany said.

Serebruany detailed his concerns about prasugrel in a letter sent today to new FDA Commission Margaret Hamburg.

Blood thinners and anti-clotting medications, such as heparin and Plavix, have been linked to an increased risk of potentially deadly excess bleeding, among other complications.

While the FDA has yet to issue a final ruling on whether to approve prasugrel, an expert panel of advisors recently recommended approval of the drug. A clinical trial with about 13,000 patients found that prasugrel outperformed the blockbuster blood-thinner Plavix at preventing potentially deadly blood clots in heart patients. However, prasugrel also was linked to a higher risk of dangerous internal bleeding.

The FDA estimated that based on the clinical study results, prasugrel would prevent more heart attacks and cardiovascular-events compared to Plavix, but also would result in more incidents of fatal bleeding, including deaths from that complication.

However, Serebruany questioned the methods used in the study which reached somewhat favorable findings on prasugrel.

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