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Tamiflu: Drugs
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In 2005, the FDA convened an advisory panel to discuss the problems with Tamiflu, but the panel concluded the events likely weren't related to Tamiflu. However, the panel recommended the agency keep monitoring the drug. On November 13, 2006, the FDA alerted doctors and parents to watch for signs of bizarre behavior in children treated with Tamiflu. At that time, The FDA updated the label after receiving the 103 reports of abnormal behavior, most of which involved children in Japan.
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Tamiflu, an oral neuraminidase inhibitor, is designed to be active against all clinically relevant influenza viruses. It works by blocking the action of the neuraminidase enzyme on the surface of the virus. When neuraminidase is inhibited, the virus is not able to spread to and infect other cells in the body. Tamiflu is the only member of the neuraminidase class of drugs approved for use in treatment and prevention of influenza in children 1 to 5 years of age.
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Tamiflu is available as a capsule containing 75 mg active drug as well as liquid suspension form for oral use. Tamiflu should be taken for a minimum of 5 days and the intake should not be ceased abruptly even if the patient starts feeling better.
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The success of Tamiflu depends on the neuraminidase factor. This drug is like using a laser as opposed to most antibiotics, which are like a shot gun. A word of caution. Tamiflu does not work on the Distemper virus or other forms of gastroenteritis.
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WASHINGTON – Food and Drug Administration experts are recommending new label warnings about possible dangerous psychiatric side effects of influenza drugs Tamiflu and Relenza, according to FDA documents. The documents, posted Friday on the FDA Web site, were prepared for a meeting Tuesday of the FDA's Pediatric Advisory Committee. Studies revealed 596 cases in which patients who took Tamiflu experienced "neuropsychiatric events" such as delirium, delusions or hallucinations. The episodes sometimes led to impulsive behavior and self-injury. Tamiflu is made by Roche Holdings.
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The deal allows Shenzhen-based HEC Group to produce the generic form of Tamiflu known as oseltamivir for use in pandemic prevention and control. The drug will be supplied through government channels, Roche said in a statement.
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