salmeterol

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    salmeterol
    serevent

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    FDA Panel Says NO to Nasal Spray Flu Vaccine

    An advisory panel to the Food and Drug Administration (FDA) on Friday voted against the approval of a highly anticipated flu vaccine delivered via nasal spray.

    In a close vote, the expert panel advised against the approval of Aviron Inc.'s FluMist due to safety concerns. The vote is significant because the FDA usually follows the recommendations of its advisory panels, although it is not bound by them.

    Unlike standard flu shots, FluMist uses components of a live influenza virus. The FDA's Vaccine and Related Biologic Committee was evaluating whether FluMist should be approved for healthy children and adults aged 12 months to 64 years.

    But because the vaccine contains live virus, the committee decided that the use of the vaccine raised too many safety concerns that still must be analyzed.

    For example, the live virus might pose a risk of infection to immune-compromised individuals and a potential risk to individuals with underlying conditions such as asthma, the committee observed. They also noted that there are few data regarding other potential side effects such as pneumonia and the concurrent administration of other childhood vaccinations--signaling a potential problem for children younger than 15 months.

    "The 15-month cut-off makes more sense given the available data," said Dr. Robert S. Daum, the panel chairman and a professor of pediatrics at the University of Chicago Children's Hospital in Illinois.

    "There is no doubt in my mind that there are some real-world concerns," added Dr. Nancy Cox, chief of the Influenza Branch at the Centers for Disease Control and Prevention (CDC).

    Still, there is a chance that the vaccine eventually might earn FDA approval.

    While admitting that there are outstanding safety issues, Aviron observed that the incidence of serious vaccine-related side effects in clinical trials was still similar to that of a sugar pill. The company also pointed out that a number of at-risk individuals who were inadvertently enrolled in the trails did not suffer from any serious side effects.

    In the clinical trials of FluMist, the most common adverse events were upper respiratory and flu-like symptoms such as a runny nose, low-grade fever and sore throat.

    "We can't go through a day like today without some disappointment," said Aviron president Boyd Clarke. "On the other hand, we can't discount the advantages of what happened today...I do believe given the comments of the committee, the day was much more positive than the safety vote."

    Panel members agreed that the data were encouraging though incomplete.

    "I feel positive that ultimately this vaccine will prove safe," said Dr. David S. Stephens, a panel member and the director of the infectious diseases division at Emory University School of Medicine in Atlanta, Georgia.

    If approved, some healthcare experts expect FluMist will offer a welcome alternative to the current intramuscular flu shot. Some doctors are reluctant to recommend the vaccine for certain patients, such as children, because it only comes in the form of a shot.

    In clinical trials involving children, the vaccine has proved highly effective. But trials in adults have not been as successful. Moreover, FluMist's safety and effectiveness in people vulnerable to flu complications--such as the elderly or people with chronic conditions such as asthma or diabetes--is unknown. The vaccine is currently in a large trial involving elderly adults.



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