Drugs
Influenza (Flu) Antiviral Drugs and Related Information
Topics on this page
- Introduction
- Influenza Vaccine Information
- Use of Antiviral Medications to Treat Influenza
- FDA Approved Drugs for Influenza
- Use of Investigational Drugs for Influenza: Emergency Use Authorizations, Emergency INDs and Clinical Trials
- Fraudulent H1N1 Influenza Products
- Other Information Updates Related to Influenza Antivirals
- Contacts for More Information
The term influenza refers to illness caused by influenza virus. This is commonly called the flu, but many different illnesses cause flu-like symptoms such as fever, chills, aches and pains, cough, and sore throat. Influenza can cause different illness patterns, ranging from mild common cold symptoms, to typical flu, to life-threatening pneumonia, bacterial infections and other complications.
There are a number of drugs approved by FDA for the treatment and prevention of influenza. Vaccination is the primary means of preventing and controlling influenza.
The following links provide information about vaccines:
- Seasonal Flu Vaccine. Information from Center for Biologics Evaluation and Research (CBER) about Seasonal Influenza Vaccine.
- Other Influenza Vaccines. Information from Center for Biologics Evaluation and Research (CBER) on general vaccine topics, including influenza vaccines.
- Seasonal Flu. Comprehensive flu information for consumers and healthcare professionals from the Centers for Disease Control and Prevention (CDC).
- Influenza Vaccine: What you need to know (PDF - 82KB). Consumer pamphlet from the CDC containing basic vaccine questions and answers.
Use of Antiviral Medications to Treat Influenza Outbreaks of influenza occur every year and typically reach epidemic levels at some part of the season. Usually, uncomplicated influenza gets better with or without treatment but may cause substantial discomfort and limit activities while it lasts. Complications of influenza can include bacterial infections, viral pneumonia, and cardiac and other organ system abnormalities. People with chronic medical conditions may be at increased risk for complications. Many other diseases, including rapidly progressive bloodstream infections, may start with symptoms that resemble influenza, and may need to be considered in treatment decisions. Laboratory tests can help detect influenza. However, a negative test does not rule out the possibility of an influenza infection, and positive tests do not exclude the possibility of other illnesses or take the place of clinical evaluation Many people with uncomplicated influenza use over-the-counter medicines, get rest, and take plenty of fluids to lessen their symptoms. Antiviral drugs available by prescription can reduce the time it takes for symptoms to improve, and are used in selected situations to reduce the chance of illness in people exposed to influenza. Complications of influenza, and other illnesses that resemble influenza, may require different treatment and, in some cases, urgent medical attention. Antiviral drugs do not eliminate the risk of complications. Some complications can be life-threatening. There have been reports of people with other types of infections that got worse because they were treated only for influenza and not for the other infections. Influenza viruses can become resistant to specific anti-influenza antiviral drugs, and all of these drugs have side effects. If you experience new symptoms during treatment or your symptoms persist or get worse during treatment, see your health care professional If a new variety of influenza is transmitted rapidly it can cause widespread illness known as a pandemic. Depending on the strain of influenza, antiviral drugs may not work to the same extent. The government stockpiles antiviral drugs, and develops recommendations about their use as part of pandemic preparations. For more information and public health recommendations about circulating influenza virus go to Flu.gov or to the CDC and WHO websites. FDA Approved Drugs for Influenza Note: Anti-influenza antiviral drugs are not a substitute for vaccine. They are used in addition to vaccine in public health planning for the control of influenza. The antiviral drugs have been approved for treatment of acute uncomplicated influenza and for some preventive uses. Tamiflu (oseltamivir phosphate) and Relenza (zanamivir) are the two FDA-approved influenza antiviral drugs recommended by CDC for use against recently circulating influenza viruses.
Older drugs, amantadine and rimantadine, are approved for treatment and prevention of influenza A. But many strains of influenza, including the 2009 H1N1 influenza, are now resistant to these two drugs. CDC currently recommends the use of these two drugs only when specific virus strains are suspected that could be susceptible to these drugs and resistant to other likely treatments.
Approved ages, doses, and dosing instructions in children are different for each drug; check the individual package inserts for more information. In addition, total daily dose and duration of dosing for treatment of acute illness may differ from the dosing and duration for prophylaxis and should be adjusted accordingly. The antiviral drug information labeling addresses side effects or adverse events of each drug. Decisions to use these drugs should be based on individual evaluations of risk and benefit. Report serious adverse events associated with these or any other drug to the MedWatch program. Influenza viruses change over time. Resistance mutations can decrease drug effectiveness. Other factors (such as viral virulence) might diminish the clinical benefit of antiviral drugs. Prescribers should consult available information about influenza drug susceptibility patterns and treatment effects before using these products. |
Use of Investigational Drugs for Influenza: Emergency Use Authorizations, Emergency INDs and Clinical Trials In addition to the antiviral drugs currently approved for treatment or prevention of influenza, new drugs or new formulations of already approved drugs may be made available through emergency use authorizations, emergency investigational new drugs, and clinical trials. Emergency Use Authorizations (EUA) Emergency INDs (EIND) Clinical Trials Information about expanded access regulations, other aspects of drug development and review, and resources about the approval status of drugs and formulations can be found at:
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Fraudulent H1N1 Influenza Products Sometimes products are promoted to treat influenza that do not have information to support their claims. During the 2009 H1N1 public health emergency, concerns arose about websites selling products claiming to prevent or cure the H1N1 influenza virus. To report a website offering suspected fraudulent H1N1 influenza products, go to Report Suspected Fraudulent Products.
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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@fda.hhs.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@fda.hhs.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
800-CDC-INFO (800-232-4636) TTY: (888) 232-6348
cdcinfo@cdc.gov
Contact FDA
Regular Mail: Use postage-paid FDA Form 3500
Mail to: MedWatch 5600 Fishers Lane
Rockville, MD 20857