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Daiichi Sankyo and Lilly Receive U.S. FDA Approval for Effient(TM)
Date:7/10/2009

udy of TRITON-TIMI 38 patients, as well as several early phase pharmacokinetic studies, showed that the active form of prasugrel does not appear to be affected by genetic variations in common cytochrome P450 (CYP) enzymes, including CYP2C19. Because both Effient and Plavix are "prodrugs", they require CYP450 enzymes to convert them to their active drug form. Approximately 30 percent of Caucasians and 60 percent of Asians have reduced function in the CYP2C19 gene. Many drugs, including certain proton pump inhibitors such as omeprazole, also inhibit CYP2C19(iii). As stated in the Plavix prescribing information, studies have shown that formation of clopidogrel's active metabolite may be affected by patients with reduced CYP2C19 function or by drugs that inhibit CYP2C19, including certain proton pump inhibitors such as omeprazole.(iv,v)

Important Safety Information about Effient

Antiplatelet medicines, including Effient, can increase the risk of bleeding. If patients have unexplained or excessive bleeding while on Effient, they should contact their doctor right away as some bleeding can be serious, and sometimes may lead to death. Patients should not take Effient if they have a stomach ulcer or other conditions that cause bleeding or if they have a history of stroke or "mini-stroke" (transient ischemic attack or TIA).

If patients are 75 or older, or if they weigh less than 132 pounds, or if they are taking anticoagulants (eg, warfarin) or taking NSAIDs (eg, ibuprofen or naproxen) for a long time, they should talk to their doctor, as they may be at an increased risk of bleeding.

If patients plan to have surgery or a dental procedure, they should tell their doctors that they are taking Effient.

Patients should not stop taking Effient without first talking to the doctor who prescribed it for them, as this may result in increased risk of a clot in their stent, a heart attack or de
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SOURCE Eli Lilly and Company
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