New Warning for Tamiflu Label

Posted July 1st, 2010. Filed under Anti Viral

INDONESIA BIRD FLU TAMIFLU

The FDA recommends that patients who take Tamiflu (Roche) to treat influenza be closely monitored for signs of abnormal behavior. Tamiflu is indicated for patients one year of age and older with uncomplicated acute illness caused by influenza who have shown symptoms for no more than two days.

More than 100 new cases of delirium, hallucinations, and other unusual psychiatric behavior have been reported in children who were given the drug. Most of these patients were children in Japan, where Tamiflu canadian usage is the highest in the world. The new cases of behavioral changes occurred between August 2005 and July 2006.

Health officials have been sensitive about taking any action that might dissuade people from taking Tamiflu, because the drug may be important in an outbreak of bird flu.

The drug does not prevent influenza, but it can reduce the length and severity of associated symptoms.

FluMistThe nasal influenza vaccine FluMist (MedImmune) is now approved to include children between two and five years of age. Approval had previously been limited to healthy children five years of age and older and to adults up to age 49. The vaccine contains a weakened form of the live virus and is sprayed into the nose.

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Raltegravir (Isentress) For HIV Infection

Posted February 8th, 2010. Filed under Anti Viral

IsentressRaltegravir tablets (Isentress, Merck) have been approved for the treatment of human immunodeficiency virus drug (HIV)-1 infection, in combination with other anti-retroviral agents, in patients who have received other therapies and who have evidence of viral replication and HIV-1 strains that are resistant to multiple antiretroviral agents.

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Eyedrops for Bacterial Conjunctivitis

Posted January 17th, 2010. Filed under Anti Viral

eyedroppersThe FDA has approved besifloxacin ophthalmic suspension 0.6% (Besivance, Bausch & Lomb), a topical eyedrop for patients with nonviral bacterial conjunctivitis.

Bacterial forms of conjunctivitis are common in childhood, but they can occur in people of any age. Symptoms can include reddened eyes, swelling, eyelids sticking together, itching, watering, and a sticky discharge from the eyes. The course usually lasts for 7 to 14 days.

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NEW DRUGS H1N1 Influenza Virus Vaccines

Posted December 14th, 2009. Filed under Anti Viral

tamiflu1The 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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Stronger Warnings Urged For Two Flu Drugs

Posted December 12th, 2009. Filed under Anti Viral

qgv45bvAn 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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