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    recent news

    Post  Admin on Thu Jun 03, 2010 8:17 am


    Recent medicine's n
    ews
    Saturday, Mar 1, 2008


    Ranolazine: A New
    Option in the Management of Chronic Stable Angina



    Pharmacotherapy for the management of chronic stable angina has not
    changed much in the past 10-20 years. Although the use of
    revascularization has increased, â-blockers, calcium channel blockers,
    and long-acting nitrates are still widely used in the management of
    patients with chronic stable angina. Despite the demonstrated
    effectiveness of these agents, a number of patients do not achieve the
    American College of Cardiology-American Heart Association goal of
    freedom from exertional angina attacks. For the first time in more than
    a decade, a new agent, ranolazine, is available to assist in
    controlling exertional angina. Ranolazine has a novel mechanism of
    action of inhibiting the late sodium current during ventricular
    depolarization. This mechanism contributes to a reduction in
    intracellular sodium and, therefore, a reduction in intracellular
    calcium, reducing ischemic injury. Unlike currently available
    pharmacotherapy for chronic stable angina, ranolazine does not produce
    clinically meaningful changes in heart rate or blood pressure. A number
    of clinical trials have demonstrated the ability of ranolazine to
    increase exercise tolerance, decrease weekly anginal episodes, and
    decrease sublingual nitroglycerin consumption for breakthrough angina.
    Based on the results of these trials, ranolazine recently was approved
    by the United States Food and Drug Administration for treatment of
    patients with chronic stable angina. Because of ranolazine's
    pharmacokinetic and pharmacodynamic profile, pharmacists will have to
    play a significant role in patient selection and monitoring.




    FDA Licenses Xyntha, a New Hemophilia Treatment

    ROCKVILLE, Md., Feb. 21, 2008--The U.S. Food and Drug Administration
    today licensed a treatment for hemophilia A, a rare, hereditary
    blood-clotting disorder that affects approximately 15,000 individuals,
    almost exclusively males, in the United States.

    The new treatment, called Xyntha Antihemophilic Factor (Recombinant)
    Plasma/Albumin Free, is a genetically engineered version of factor
    VIII, a protein essential for the clotting of blood. Factor VIII,
    known as an anti-hemophilic factor, is missing or decreased in
    patients with hemophilia A.

    Xyntha is licensed for the control and prevention of bleeding, which
    can occur spontaneously or after an accident or injury in patients
    diagnosed with hemophilia A. Xyntha is also licensed to help prevent
    surgical bleeding in this patient population.

    Xyntha is manufactured using recombinant DNA techniques that enable
    scientists to create new DNA strands with specific traits, such as the
    capacity to produce a specific protein.

    To make Xyntha, genes from Chinese Hamster Ovary cells (CHO) are
    modified to produce factor VIII. These CHO cells are free from known
    infectious agents, and Xyntha undergoes an additional process of viral
    inactivation. Also, the culture in which the cells are grown is free
    of any human or animal material.

    "This product provides an additional treatment option for hemophilia A
    patients. This recombinant Factor VIII is produced without additives
    from human or animal material, which further minimizes any risk of
    infection from the product," said Jesse Goodman, M.D., M.P.H.,
    director of FDA's Center for Biologics Evaluation and Research.

    In clinical trials, Xyntha was shown to be effective at preventing or
    controlling bleeding, including preventing bleeding in surgery, for
    hemophilia A patients. Generally, the most frequently reported adverse
    reaction was headache. For those receiving Xyntha to prevent bleeding
    in surgery, the most frequently reported adverse reaction was fever.
    Most adverse reactions reported in either study were considered mild
    or moderate in severity.

    In addition, two of 89 individuals who received 50 days of treatment
    with Xyntha, developed factor VIII inhibitors, which are antibodies
    that counteract treatment with factor VIII.

    Xyntha is manufactured by Wyeth Pharmaceuticals Inc., located in
    Philadelphia.

      Current date/time is Sat Dec 03, 2016 10:38 am