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Influenza Antiviral Drugs and Related Information
Introduction
The term "influenza" refers to illness caused by influenza virus. This is
commonly also called "flu", but many different illnesses cause
"flu-like" systemic and respiratory symptoms such as fever, chills, aches and
pains, cough, and sore throat. In addition, influenza itself can cause many different
illness patterns, ranging from mild common cold symptoms to typical "flu" to
life-threatening pneumonia and other complications, including secondary bacterial
infections.
This web site contains links to several sources of general
information about influenza. Because vaccination is the primary means of preventing and
controlling influenza, links related to influenza vaccine are listed first, followed by
links related to antiviral drugs that have been approved in the United States for
influenza. After the vaccine and antiviral drug links, there is a list of web sites that
provide additional influenza information from United States government agencies and the
World Health Organization, and a list of contacts for further inquiries.
Information provided on this web site may change
frequently, and should not be used as a substitute for individual evaluation by a health
care provider, or as the primary means of diagnosing influenza or determining treatment.
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Influenza vaccine is the principal method of preventing and controlling
influenza. The following links provide information on general uses of vaccines and on
current supply issues.
Drug Information
Uncomplicated influenza gets better with or without
treatment, but may cause substantial discomfort and limitation of activity before getting
better. Complications of influenza can include bacterial infections, viral pneumonia, and
cardiac and other organ system abnormalities. People with chronic medical conditions may
have increased risk of complications when they get influenza. Many other diseases,
including serious infections such as rapidly progressive bacteremias, may start with
symptoms that resemble influenza and may need to be considered in treatment decisions.
Many people with uncomplicated influenza use over-the-counter medicines to help lessen
their symptoms. Antiviral drugs can also help to reduce the time it takes for symptoms to
improve in uncomplicated illness caused by influenza virus. Recent increases in the number
and promotion of antiviral drugs for influenza have increased interest in the role of
specific antiviral drugs for this condition.
Complications of influenza, and other illnesses that resemble influenza, may require
different treatment and may need urgent medical attention. Use of antiviral drugs does not
eliminate the risk of complications, and some complications (as well as other medical
conditions that could be confused with influenza) can be life-threatening. In addition,
influenza viruses can become resistant to specific anti-influenza antiviral drugs, and all
of the drugs have side effects. Therefore, if you have new symptoms during treatment, or
your symptoms persist or get worse during treatment, you should see your health care
provider.
The following links lead to information
such as trade names, package inserts, and other material related to the four antiviral
drugs currently approved by FDA to treat acute, uncomplicated influenza.
Two related drugs, amantadine (approved 1966; Trade
Name Symmetrel, also available as generic Amantadine Hydrochloride) and
rimantadine (approved 1993; Trade Name Flumadine, also available as generic
Rimantadine Hydrochloride), are approved for treatment and prevention of
influenza A. Two newer drugs, zanamivir
(approved 1999; Trade Name Relenza) and oseltamivir phosphate (approved
1999; Trade Name Tamiflu), are approved for treatment of acute uncomplicated
illness due to influenza A and B. Oseltamivir has been
approved also for preventive use, while zanamivir is approved only for treatment. Approved ages, doses, and uses in children are different for each drug, so the individual
package inserts should be checked for this information. The anti-influenza
antiviral drugs are not a substitute for vaccine and are used only as an adjunct to
vaccine in the control of influenza.
The antiviral drug information covers the side
effects of each drug. Because some side effects can be serious and because viruses may
become resistant when antiviral drugs are used indiscriminately, decisions on the use of
these drugs should be based on individual evaluations of risk and benefit.
FDA encourages reporting of serious adverse events
(associated with these or any other drugs) to the MedWatch program
to facilitate continued updating of risk/benefit information.
-
Symmetrel (amantadine). Approval, review, and labeling information
from Drugs@FDA.
-
Flumadine (rimantadine). Approval, review, and labeling information
from Drugs@FDA.
- Relenza (zanamivir). Approval,
review, and labeling information from Drugs@FDA, plus consumer
information, and Dear Health Professional letter regarding updated safety
information.
- Tamiflu (oseltamivir
phosphate). Approval, review, and labeling information from
Drugs@FDA, plus consumer information.
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Office of Generic Drugs -
Statement on Expedited Review of Generic Drug Products for the
Prophylaxis and Treatment of Illness Caused by Various Strains of
the Influenza Virus. (10/18/2004)
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MedWatch site for Adverse
Event Reporting. Information and instructions for reporting of adverse events
associated with medical products such as prescription or nonprescription
drugs, biologics, and medical devices.
- Electronic Orange Book
This resource can be searched for holders of approved or discontinued
marketing applications, especially for drugs that may have more than one
source of generic preparations.
- Centers for Disease
Control and Prevention: Prevention and Control of Influenza: Recommendations
of the Advisory Committee on Immunization Practices (Issued
May 28, 2004).
- Public Health Advisory:
Safe and Appropriate Use of Influenza Drugs. (Issued 1/12/2000). Health
professionals, especially prescribers, are reminded of important clinical decisions that
need to be made when considering use of anti-viral drugs for signs and symptoms of
influenza.
- Talk Paper: FDA Reminds
Prescribers of Important Considerations before Prescribing Flu Drugs (Issued 1/12/00).
- Letter from the Glaxo
Wellcome, Inc.on Relenza (zanamivir for inhalation). (Issued 7/2000). Optional format: PDF. This
letter notifies health professionals of important revisions to the safety labeling for
Relenza. The labeling has been revised to more clearly reflect that serious respiratory
adverse events have been reported in patients with or without known underlying respiratory
disease, and to incorporate additional updated safety information.
- A
Look at the 2003-2004 Flu Season.
March-April, 2004 FDA Consumer magazine article on influenza prevention
and treatment.
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Information on availability of
influenza vaccine:
Food and Drug Administration
Center for Biologics Evaluation and Research
Office of Communication, Training & Manufacturers Assistance
301-827-1800. Fax: 301-827-3843
octma@cber.fda.gov
Information on drugs used to treat
influenza:
Food and Drug Administration
Center for Drug Evaluation and Research
Drug Information Line
888-info-FDA or 301-827-4573. Fax: 301-827-4577
druginfo@cder.fda.gov
Information on influenza prevention
and control:
Centers for Disease Control and Prevention
Public Inquiries Office
800-311-3435 or 404-639-3311. Fax: 770-488-4995
inquiry@cdc.gov
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Updated: November 04, 2004 |
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