A US Food and Drug Administration (FDA) review of Eli Lilly`s blood-thinning drug prasugrel may be halted after a warning from the US consumer watchdog Public Citizen.
It says that a Lilly study does not give an accurate comparison of prasugrel versus Plavix, the world’s second-best-selling medication, made by Sanofi-Aventis and Bristol-Myers Squibb.
According to a study of over 13,000 patients conducted by Lilly, the drug prevents more heart attacks than Plavix, but it also causes more internal bleeding.
The watchdog claims that the prasugrel dose under review is 2.5 times stronger than a dose of Plavix and actually stops blood clotting completely, which puts the increased risk to patients of haemorrhages at an unacceptable level.
The claim is co-signed by Dr Victor Serebruany, a research professor at Johns Hopkins University. He worked on the early development of prasugrel and is listed on a patent application for the drug.
Copyright Press Association 2009