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July 10 the Office of the Food and Drug Administration spn USA (Food and Drug Administration - FDA) announced the approval of an antithrombotic drug Effient / Effient (prazugrel, Eli Lilly & Co. / Daiichi Sankyo ), is used in patients undergoing angioplasty. Management also noted that the instructions spn for use of the drug will include a warning about the likelihood of significant, sometimes fatal, spn bleeding. The company said they were planning to begin marketing the drug in the U.S. in the coming weeks.
The FDA decision is based on the results of a study involving more than 13,600 patients, which compared the efficacy of the drug Effient and Plavix / Plavix (clopidogrel, sanofi-aventis / Bristol-Myers spn Squibb ) in patients at risk of heart attack or patients who have had a heart attack, which was planned to conduct angioplasty. The results of this study showed that patients treated with Effient, the probability of subsequent cases of non-fatal heart attacks was reduced (7%) compared with those taking Plavix (9,1%). However, the high risk of major bleeding was observed in patients treated with Effient.
The instructions spn for use Effient will indicate that the drug was not used for patients with abnormal spn bleeding, if a history of transient ischemic attacks or stroke, as well as the urgent surgery, including coronary bypass surgery. The representative spn of the company Bristol-Myers Squibb Laura Hortas (Laura Hortas) noted that Effient spn is approved only for the part of the patient population for the application for which also approved Plavix.
Despite the abundance of contraindications to the use of Effient, Anthony Vear (Anthony Ware), Vice-President of Eli Lilly & Co. , Believes that this will not have any significant effect on the marketing spn of the drug. He said his company believes it is important to inform patients and physicians about the risks of bleeding, sometimes very large, the doctor can make the right decision on the appointment of the drug, weighing the risks and benefits of its application? According CNN Money .
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