FDA 2009 H1N1 (Swine) Flu Page

Update: FDA Commissioner Addresses Nation's Healthcare Professionals on H1N1 Vaccine On November 10, Dr. Margaret Hamburg, Commissioner of Food and Drugs, sent a letter to America’s healthcare professionals thanking them for their efforts during the 2009 H1N1 influenza outbreak and providing information on the safety of the 2009 H1N1 vaccines. View letter The FDA plays a vital role on the team led by the U.S. Department of Health and Human Services in the fight against the 2009 H1N1 virus. The agency works closely with the Centers for Disease Control and Prevention, National Institutes of Health, other federal government agencies, and global partners such as the World Health Organization and foreign governments to protect public health during the 2009 H1N1 pandemic.  Topics on this Page: H1N1 Flu Vaccine Consumer Protection: Fraudulent H1N1 Claims and Bogus H1N1 Products Antiviral Drugs Diagnostic Tests Safety of the Food Supply Safety of the Blood Supply Supply of Masks, Gloves and Other Personal Protective Equipment

Spotlight Q&A for Health Care Providers: Renal Dosing and Administration Recommendations for Peramivir IV (PDF, 22 KB) FDA Expands Approved Use of H1N1 Vaccines to Include Infants and Children FDA Commissioner Addresses Nation’s Healthcare Professionals on H1N1 Vaccine Guidance to Pharmacies on Advance Compounding of Tamiflu Oral Suspension to Provide for Multiple Prescriptions

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H1N1 Flu Vaccine 

FDA ensures the safety, effectiveness and supply of the H1N1 flu vaccine.

• How the flu vaccine is made (PDF, 248 KB)
• H1N1 vaccine ingredients
• H1N1 vaccine questions and answers
• Use of Influenza A (H1N1) 2009 Monovalent Influenza Vaccine in Pregnant Women
• Dear health care professionals letter regarding 2009 H1N1 flu virus (June 18)
• Complete information on each H1N1 flu vaccine
  • Injectable vaccine
    • ID Biomedical Corporation of Quebec
    • CSL
    • Novartis
    • Sanofi Pasteur
  • Intranasal vaccine
    • MedImmune
  • Safety monitoring
• FDA update on the H1N1 flu vaccine and antiviral medications (no date)
• News Releases
  • FDA Approves Additional Vaccine for 2009 H1N1 Influenza Virus (November 16)
  • FDA Expands Approved Use of H1N1 Vaccines to Include Infants and Children (November 12)
  • FDA Approves Vaccines for 2009 H1N1 Influenza Virus (September 15)
  • FDA Approves New Influenza Vaccine Production Facility (May 6)

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Consumer Protection: Fraudulent H1N1 Claims and Bogus H1N1 Products 

FDA tracks and prosecutes advertisers who make fraudulent claims in ads about preventing or treating the H1N1 virus.

Fraudulent Products Widget List of fraudulent 2009 H1N1 influenza products list The Word is Out on Unapproved H1N1 Products (October 23) Warning letters to companies making false claims about their H1N1 products Report suspected fraudulent products or criminal activity associated with H1N1 flu virus (swine flu ) News Releases FTC Warns Internet Peddlers that Marketing Unproven H1N1 Flu Products May Be Illegal (November 16) FDA, FTC Issue Joint Warning Letter to Web Site Offering Fraudulent H1N1 Flu Supplements (October 19) FDA Warns of Unapproved and Illegal H1N1 Drug Products Purchased Over the Internet (October 15) FDA Warns Web Sites against Marketing Fraudulent H1N1 Flu Virus Claims (June 15) FDA, FTC Warn Public of Fraudulent 2009 H1N1 Influenza Products (May 1)

H1N1 Fraudulent Products

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Antiviral Drugs 

FDA ensures the safety, effectiveness and supply of flu antiviral drugs.

• Drug Treatments for Flu (antivirals)
• Guidance to Pharmacies on Advance Compounding of Tamiflu Oral Suspension to Provide for Multiple Prescriptions (October 31)
• Updated Questions and Answers: 2009 H1N1 Flu Virus and Emergency Use Authorization of Tamiflu and Relenza  (October 31)
• Peramivir IV Questions and Answers for Health Care Providers
• Q&A for Health Care Providers: Renal Dosing and Administration Recommendations for Peramivir IV (PDF, 22 KB)
• Pregnancy and antiviral use
• Tamiflu Oral Suspension Shortage Information
• Stockpiled Antivirals at or Nearing Expiration
• FDA public health alert: potential medication errors with Tamiflu for oral suspension (September 25)
• Information for healthcare professionals: authorization of use of expired Tamiflu for oral suspension (October 2)
• Dear health care professionals letter regarding 2009 H1N1 flu virus (June 18)
• FDA update on the H1N1 flu vaccine and antiviral medications (no date)
• Emergency use authorizations
• Emergency use authorizations questions and answers (April 28)
• FDA and CDC Information on Potential “Spot Shortages” of Supplies for Treating and Preventing Novel Influenza A (H1N1) (June 18)
• News Releases
  • FDA Authorizes Emergency Use of Intravenous Antiviral Peramivir for 2009 H1N1 Influenza for Certain Patients, Settings (October 23)
  • FDA Authorizes Emergency Use of Influenza Medicines, Diagnostic Test in Response to Swine Flu Outbreak in Humans (April 27)

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Diagnostic Tests 

FDA approves diagnostic tests for laboratories, clinics and doctor’s offices.

• Medical devices for flu diagnosis and protection (October 16)
• Dear health care professionals letter regarding 2009 H1N1 flu virus (June 18)
• Health care professional fact sheet: interpreting swine influenza RT-PCR detection panel test results (May 2)
• Patient fact sheet: understanding swine flu kit test results (May 2009)
• Emergency Use Authorizations for Devices (April 28)
• News Releases
  • FDA Authorizes Emergency Use of H1N1 Test for U.S. Troops Serving Overseas (August 25)
  • FDA Authorizes Emergency Use of Another Test for 2009 H1N1 Influenza Virus (July 24)
  • FDA Authorizes Emergency Use of Influenza Medicines, Diagnostic Test in Response to Swine Flu Outbreak in Humans (April 27)

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Safety of the Food Supply 

FDA ensures the safety of the food supply.

• H1N1 virus and the food supply
• Food industry questions and answers

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Safety of the Blood Supply 

• FDA ensures the safety of the blood supply.

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Supply of Masks, Gloves and Other Personal Protective Equipment 

FDA monitors the supply of facemasks, respirators and other personal protective equipment.

• Personal protective equipment – facemasks, respirators, etc. general information
• Questions and answers
• FDA and personal protective equipment for the 2009 H1N1 flu virus (September 15)

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