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August 27, 2009 — The World Health Organization (WHO) has issued guidelines for antiviral treatment

of novel influenza A (H1N1) and other influenza. The purpose of the new recommendations, which
were posted online August 20, is to provide a basis for advice to clinicians regarding the use of the
currently available antivirals for patients presenting with illness caused by influenza virus infection, as
well as considerations regarding potential use of these antiviral medications for chemoprophylaxis.
On the basis of a review of data collected with previously circulating strains, and treatment of human
H5N1 influenza virus infections, the new guidelines expand on recommendations published in May
2009, titled "Clinical management of human infection with new influenza A (H1N1) virus: Initial
guidance." These new guidelines do not change recommendations in the WHO rapid advice guidelines
on pharmacological management of humans infected with highly pathogenic avian influenza A (H5N1)
virus.
"In April 2009, the [WHO] received reports of sustained person to person infections with [H1N1] virus
in Mexico and the United States," write Edgar Bautista, from Médico Neumólogo Intensivista, Jefe de
UCI-INER in Mexico, and colleagues. "Subsequent international spread led WHO to declare on 11
June 2009 that the first influenza pandemic in 41 years had occurred. This 2009 pandemic H1N1
influenza virus has now spread worldwide, with confirmed cases of pandemic H1N1 virus infection
reported in more than 100 countries in all 6 WHO regions[, which] has led to the need to add to the
existing guidance on the use of antivirals."

The new recommendations highlight oseltamivir and zanamivir, which are neuraminidase inhibitors,
and amantadine and rimantadine, which are M2 inhibitors. Suggestions are also provided regarding
the use of some other potential pharmacological treatments, such as ribavirin, interferons,
immunoglobulins, and corticosteroids.

Management of patients with pandemic influenza (H1N1) 2009 virus infection is the primary focus of
the statement, although it also includes guidance regarding the use of the antivirals for treatment of
other seasonal influenza virus strains, as well as for infections resulting from novel influenza A virus
strains.
The guidelines urge country and local public health authorities to issue local recommendations for
clinicians periodically, based on epidemiological and antiviral susceptibility data on the locally
circulating influenza strains. As the prevalence and severity of the current pandemic evolves, WHO
anticipates that additional data will be forthcoming that may require revision of the current
recommendations. WHO therefore plans to review the guidance no later than September 2009 to
determine whether modifications to the recommendations are needed.

Recommendations for Antiviral Treatment of H1N1


For patients with confirmed or strongly suspected infection with influenza pandemic (H1N1) 2009,
when antiviral medications for influenza are available, specific recommendations regarding use of
antivirals for treatment of pandemic (H1N1) 2009 influenza virus infection are as follows:

Oseltamivir should be prescribed, and treatment started as soon as possible, for patients with severe
or progressive clinical illness (strong recommendation, low-quality evidence). Depending on clinical
response, higher doses of up to 150 mg twice daily and longer duration of treatment may be indicated.
This recommendation is intended for all patient groups, including pregnant women, neonates, and
children younger than 5 years of age.

Zanamivir is indicated for patients with severe or progressive clinical illness when oseltamivir is not
available or not possible to use, or when the virus is resistant to oseltamivir but known or likely to be
susceptible to zanamivir (strong recommendation, very low-quality evidence).
Antiviral treatment is not required in patients not in at-risk groups who have uncomplicated illness
caused by confirmed or strongly suspected influenza virus infection (weak recommendation, low-
quality evidence). Patients considered to be at risk are infants and children younger than 5 years of
age; adults older than 65 years of age; nursing home residents; pregnant women; patients with chronic
comorbid disease including cardiovascular, respiratory, or liver disease and diabetes; and
immunosuppressed patients because of malignancy, HIV infection, or other diseases.
Oseltamivir or zanamivir treatment should be started as soon as possible after the onset of illness in
patients in at-risk groups who have uncomplicated illness caused by influenza virus infection (strong
recommendation, very low-quality evidence).
Recommendations for Chemoprophylaxis of H1N1
Specific recommendations regarding the use of antivirals for chemoprophylaxis of pandemic (H1N1)
2009 influenza virus infection are as follows:
When risk for human-to-human transmission of influenza is high or low, and the probability of
complications of infection is high, either because of the influenza strain or because of the baseline risk
of the exposed group, use of oseltamivir or zanamivir may be considered as postexposure
chemoprophylaxis for the affected community or group, for individuals in at-risk groups, or for
healthcare workers (weak recommendation, moderate-quality evidence).
Individuals in at-risk groups or healthcare personnel do not need to be offered antiviral
chemoprophylaxis if the likelihood of complications of infection is low. This recommendation should be
applied independent of risk for human-to-human transmission (weak recommendation, low-quality
evidence).
For treatment of mild to moderate uncomplicated clinical presentation of infection with multiple
cocirculating influenza A subtypes or viruses with different antiviral susceptibilities, patients in at-risk
groups should be treated with zanamivir or oseltamivir plus M2 inhibitor (noting that amantadine
should not be used in pregnant women). Otherwise-healthy patients with this presentation need not be
treated.
When the clinical presentation of infection with multiple cocirculating influenza A subtypes or viruses
with different antiviral susceptibilities is severe or progressive, all patients should be treated with
oseltamivir plus M2 inhibitor, or zanamivir.
For treatment of mild to moderate uncomplicated clinical presentation of infection with sporadic
zoonotic influenza A viruses including H5N1, the at-risk population should be treated with oseltamivir
or zanamivir, and the otherwise-healthy population with oseltamivir. All patients, regardless of risk
status, with severe or progressive presentation of infection with sporadic zoonotic influenza A viruses
including H5N1 should be treated with oseltamivir plus an M2 inhibitor.
WHO Rapid Advice Guidelines on Pharmacological Management of Influenza Virus. Published online
August 20, 2009.
Clinical Context
H1N1 influenza infection transmitted person to person was first detected by WHO in April 2009.
Although the first cases were limited to Mexico and the United States, subsequent spread overseas
resulted in WHO declaring on June 11, 2009, the first influenza pandemic to occur in 41 years.
Cases of pandemic H1N1 virus infection have now been confirmed in more than 100 countries in all 6
WHO regions, mandating updated recommendations on the use of antivirals for infections caused by
new strains of pandemic (A)H1N1 virus. The present WHO guidelines also address antiviral use in
seasonal influenza and in infections caused by other novel influenza A viruses, but they do not change
existing guidelines on pharmacological management of humans infected with H5N1 virus.
Study Highlights
When antiviral medications for influenza are available, patients with confirmed or strongly suspected
infection with influenza pandemic (H1N1) 2009 should be treated as follows:
All patient groups, including pregnant women, neonates, and young children younger than 5 years,
with severe or progressive clinical illness should be treated as soon as possible with oseltamivir
(strong recommendation, low-quality evidence).
Higher doses up to 150 mg twice daily and longer duration of treatment may be needed, depending on
clinical response.
Patients with severe or progressive clinical illness should receive zanamivir when oseltamivir is not
available or not possible to use, or when the virus is resistant to oseltamivir but known or likely to be
susceptible to zanamivir (strong recommendation, very low-quality evidence).
Patients considered to be "at risk" are infants and children younger than 5 years, adults older than 65
years, nursing home residents, pregnant women, patients with chronic comorbidities (cardiovascular,
respiratory or liver disease, and diabetes), and immunosuppressed patients as a result of malignant
disease, HIV infection, or other diseases.
Patients not in "at-risk" groups with uncomplicated illness because of confirmed or strongly suspected
H1N1 infection may not need antiviral treatment (weak recommendation, low-quality evidence).
Patients in "at-risk" groups with uncomplicated illness because of confirmed or strongly suspected
H1N1 infection should be started with oseltamivir or zanamivir treatment as soon as possible after
illness onset (strong recommendation, very low-quality evidence).
Specific recommendations regarding use of antivirals for chemoprophylaxis of pandemic (H1N1) 2009
influenza virus infection are as follows:
Oseltamivir or zanamivir may be used postexposure as chemoprophylaxis when risk for human-to-
human transmission of influenza is high or low, and risk for complications of infection is high, either
because of the influenza strain or because of the baseline risk for the exposed group:
In this setting, oseltamivir or zanamivir may be used in the affected community or group, in individuals
in "at-risk" groups, or in healthcare workers (weak recommendation, moderate-quality evidence).
If the risk for complications of infection is low, individuals in "at-risk" groups or healthcare personnel
may not need antiviral chemoprophylaxis, independent of risk for human-to-human transmission (weak
recommendation, low-quality evidence).
Clinical Implications
Patients with confirmed or strongly suspected infection with influenza pandemic (H1N1) 2009 should
be treated as soon as possible with oseltamivir if they have severe or progressive clinical illness, when
the drug is available, and when the virus is not resistant.
Oseltamivir or zanamivir may be used postexposure as chemoprophylaxis when the risk for human-to-
human transmission of influenza is high or low, and risk for complications of infection is high, either
because of the influenza strain or because of the baseline risk for the exposed group.
CME/CE Test
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Questions answered incorrectly will be highlighted.
According to the WHO guidelines for antiviral treatment of H1N1 and other influenzas, which
of the following statements about specific recommendations regarding use of antivirals for
treatment of pandemic (H1N1) 2009 influenza virus infection is not correct?
All patients with severe or progressive clinical illness should be treated as soon as
possible with oseltamivir when available and when the virus is not resistant
Neonates with severe or progressive clinical illness should not receive oseltamivir
Higher doses of oseltamivir up to 150 mg twice daily and longer duration of treatment
may be needed for patients with severe or progressive clinical illness
Patients not in "at risk" groups with uncomplicated illness because of confirmed or
strongly suspected H1N1 infection may not need antiviral treatment
According to the WHO guidelines for antiviral treatment of H1N1 and other influenzas, which
of the following statements about specific recommendations regarding use of antivirals for
chemoprophylaxis of pandemic (H1N1) 2009 influenza virus infection is correct?
Even if the risk for complications of infection is low, healthcare personnel should receive
chemoprophylaxis
Even if the risk for complications of infection is low, individuals in "at-risk" groups should
receive chemoprophylaxis
Zanamivir should not be used postexposure as chemoprophylaxis
Oseltamivir or zanamivir may be used postexposure as chemoprophylaxis when the risk
for complications of infection is high
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o 2009 Safety Alerts for Human Medical Products
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Covidien Pedi-Cap End-Tidal


CO2 Detector
Audience: Anesthesiology healthcare professionals, hospital risk
managers, surgical service managers
[Posted 09/10/2009] FDA notified healthcare professionals of a Class I
recall of Pedi-Cap End-Tidal CO2 Detector (Pedi-Cap and Pedi-Cap 6),
because the device may increase the resistance of the flow of air into
the lungs, resulting in ineffective ventilation and the inability to verify
the correct placement of a breathing tube when inserting it into the
windpipe. This device is used in pediatric patients, weighing 2.2-33
pounds, during the process of exchanging oxygen for carbon dioxide
(ventilation) in healthcare settings. There is a reasonable probability
that use of the recalled PediCap will cause serious adverse health
consequences or death. Covidien informed their distributors and
customers to stop selling/using the affected devices and to return
them to the company.
Any adverse events or quality problems that may be related to the use
of this product should be reported to the FDA's MedWatch Adverse
Event Reporting program online, by phone [ 1-800-332-
1088 1-800-332-1088], or by returning the postage-paid FDA
Form 3500 by mail or fax [1-800-FDA-0178].
[09/10/2009 - Recall Notice - FDA]
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Page Last Updated: 09/10/2009
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