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Tuesday, April 28, 2009

FDA Okays Emergency Use of Antiviral Drugs, Diagnostic Test for Swine Flu

The FDA's Emergency Use Authorization (EUA) relaxes current restrictions on 2 antiviral medications — zanamivir (Relenza) and oseltamivir (Tamiflu) — that the CDC recommends for preventing and treating swine influenza A (H1N1). Oseltamivir currently is approved for patients aged 1 year and older. Under the EAU, healthcare providers can administer oseltamivir to patients younger than 1 year and provide alternate dosing to patients aged 1 year and older.

Treat the Flu with TAMIFLU
When you or someone in your family begins to experience flu symptoms, you have 48 hours to take action. Trust TAMIFLU, the number-one prescribed antiviral flu medicine*:
For flu treatment: When taken within two days of experiencing symptoms, TAMIFLU works by helping to stop the flu virus from spreading inside the body
For flu prevention: When you have been exposed to someone with the flu, taking TAMIFLU can help keep the virus from making you sick
TAMIFLU is not a substitute for the flu shot; vaccination is the first line of defense for flu protection.
Treatment with Tamiflu should start as soon as possible when flu symptoms appear, such as fever, chills, muscle aches, sore throat, and runny or stuffy nose.
Take this medication for as many days as it has been prescribed for you even if you begin to feel better. Your symptoms may start to improve before the infection is completely treated.
TAMIFLU ( GENERIC )
Generic Name: oseltamivir (os el TAM ih veer)
Brand Names: Tamiflu
RX ONLY
Only your healthcare professional can determine if TAMIFLU is right for you.
What is TAMIFLU?
Tamiflu is an antiviral medication that blocks the actions of influenza virus types A and B in your body. It works by stopping the flu virus from reproducing.
Tamiflu is used to treat flu symptoms caused by influenza virus in patients who have had symptoms for less than 2 days. Tamiflu may also be given to prevent influenza in people who may be exposed but do not yet have symptoms.
TAMIFLU attacks the influenza virus and stops it from spreading inside your body. TAMIFLU treats
flu at its source, by attacking the virus that causes the flu, rather than simply masking symptoms.
TAMIFLU is for treating adults and children age 1 and older with the flu whose flu symptoms started
within the last day or two. TAMIFLU can also reduce the chance of getting the flu in people age 1 and
older who have a higher chance of getting the flu because they spend time with someone who has the
flu. TAMIFLU can also reduce the chance of getting the flu if there is a flu outbreak in the community.
What is “Flu”?
“The flu” is an infection caused by the influenza virus. Flu symptoms include fever (usually 100ºF to
103ºF in adults, and sometimes higher in children) and problems such as cough, sore throat, runny or
stuffy nose, headaches, muscle aches, fever, and extreme tiredness. Many people use the term “flu” to
mean any combination of these symptoms, such as the common cold, but true influenza infection is
often worse and may last longer than a cold.
Flu outbreaks happen about once a year, usually in the winter, when the influenza virus spreads widely
in the community. Outside of those outbreaks, only a very tiny number of respiratory infections are
caused by the influenza virus.
Should I get a flu shot?
TAMIFLU is not a substitute for a flu vaccination. You should continue to get a flu vaccination every
year, according to your healthcare professional’s advice.
Who should not take TAMIFLU?
Some people using Tamiflu have had rare side effects of sudden confusion, delirium, hallucinations, unusual behavior, or self-injury. These symptoms have occurred most often in children. It is not known whether Tamiflu was the exact cause of these symptoms. However, anyone using this medication should be watched closely for signs of confusion or unusual behavior. Call a doctor at once if you or the child using this medication has any of these.
Tamiflu should not be used in place of getting a yearly flu shot. The Centers for Disease Control recommends an annual flu shot to help protect you each year from new strains of influenza virus.
Do not take TAMIFLU if you are allergic to the main ingredient, oseltamivir phosphate, or to any
other ingredients of TAMIFLU. Before starting treatment, make sure your healthcare professional
knows if you take any other medicines, or are pregnant, planning to become pregnant, or breastfeeding.
TAMIFLU is normally not recommended for use during pregnancy or nursing, as the effects on the unborn child or nursing infant are unknown. TAMIFLU is not recommended for use in children
younger than 1 year of age.
Tell your healthcare professional if you have any type of kidney disease, heart disease, respiratory
disease, or any serious health condition.