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 Posted: Tue 10:42, 12 Nov 2013 Post subject: Genentech |
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FDA: Spot shortages for flu drug Tamiflu, but there should be enough
WASHINGTON, Jan. 19 () -- The elderly, pregnant, and those with asthma, diabetes or heart disease with the flu should get antivirals, but there are some shortages, a U.S. official says. Margaret Hamburg, commissioner of the U.S. Food and Drug Administration, said the agency has been working closely with the Centers for Disease Control and Prevention in Atlanta to monitor and help address both the supply and distribution of flu vaccines and anti-viral treatment. If someone is either high risk or in one of those high risk groups, very young or very old should be treated in the first 48 hours, Hamburg said. "Some locations may experience intermittent, temporary shortages of the oral suspension form of the anti-viral, Tamiflu,[url=http://www.apollo13show.com/]michael kors handbags outlet[/url], which is the liquid version often prescribed for children for the remainder of the flu season," Hamburg told reporters during a telephone news conference. "The FDA has been working with the manufacturer, Genentech, to increase supply and is reminding healthcare professionals that FDA-approved instructions on the label provide directions for pharmacists on how to make a liquid form of Tamiflu from the Tamiflu capsules if the oral suspension product is not available. I want to assure patients also that Tamiflu 30 milligram and 40 milligram capsules remain available and pediatric patients age 1 and older can be dosed correctly using the 30 milligram and 40 milligram capsules."However, pediatric patients less than 1 year of age should be given Tamiflu oral suspension, preferably the commercial oral suspension product or if that isn't available, then the suspension prepared by the pharmacist according to the current label instructions, Hamburg said. "Tamiflu 75 milligram capsules are currently available, but supplies may run low if many pharmacies have to use the capsules to prepare an oral suspension for pediatric patients or use to fill large numbers of prescriptions for adult patients," Hamburg said. "So to help avoid a shortage, the FDA is now allowing Genentech to distribute 2 million units of Tamiflu at the 75 milligram capsule level that have an older version of the package insert."
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