Prasugrel not pleasing

June 3, 2009 – 1:51 pm by Colette Pilkus

Since January 2008, FDA has been discussing the benefits over the risks of Eli Lilly’s prasugrel. The drug prevents more heart attacks than Plavix, but causes more internal bleeding, according to a study conducted by Lilly.

Consumer health advocates and Dr. Victor Serebruany, who worked on the early development of prasugrel and holds the patent on the drug, are asking FDA to stop its review of the drug, stating in a letter, that it may be unsafe at the suggested does of 10 milligrams. Public Citizen says that the study did not give an accurate comparison between prasugrel and Plavix, claiming that the prasugrel dose studied by Lilly was 2.5 times stronger than the dose of Plavix. The higher dose of prasugrel, scientists say, is causing the excess bleeding and that some patients on the drug stopped forming blood-clotting platelets altogether, putting them at risk of hemorrhages. The letter also questions the long-term safety of the drug, since research found that most of the drug’s heart attack preventing benefit was seen in the first week of therapy. 

In February, FDA advisor’s unanimously recommended approval of prasugrel, since they pointed out that prasugrel prevented 24 heart-related problems for every 10 bleeding events it caused. 

Tags: Eli Lilly, FDA, Plavix, prasugrel