The FDA has approved four vaccines to protect the population against the 2009 pandemic H1N1 influenza virus. About 45 million doses should be available at 90,000 sites in October. The government has ordered 195 million doses. CSL Ltd., MedImmune LLC, Sanofi-Pasteur, and Novartis Vaccines/Diagnostics Ltd. are using the same processes to make the H1N1 vaccines. Based on preliminary data, the 2009 H1N1 vaccines induce a robust immune response in most healthy adults eight to 10 days after a single dose. Clinical studies are under way to determine the optimal dose for children.

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An advisory panel of the FDA has recommended stronger warnings for the influenza drug zanamivir (Relenza, Glaxo-SmithKline). The panel wanted the label to mention the potential for abnormal psychiatric side effects, sometimes leading to death. The panel also recommended additional warnings for oseltamivir (Tamiflu drug, Roche).

The panel reviewed a small but rising number of cases, mostly in Japan. In the case of generic Tamiflu, erratic behavior, including jumping from buildings, resulted in deaths. The FDA described reports of approximately 700 cases of psychiatric adverse events for both drugs and 25 cases of pediatric deaths in patients taking (buy) Tamiflu. No fatalities were reported for Relenza.

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