Archive for April, 2009

OMNI Postings of 4/30/09

Have you heard about the man who did it with a parakeet? He contracted chirpes.
And the worst thing? It was untweetable.

But I digress….

At last count we’re up to 91 cases in the U.S. While there is still 1 case in Ohio, there is a “probable” case and a handful of “suspected” cases. There are 2 confirmed cases in MI.
http://omniphysicians.com/2009/04/30/91-cases/

Here is the TX health department’s synopsis of what happened to that baby who died from swine flu.
http://omniphysicians.com/2009/04/30/on-that-kid-who-died/

Here are the new CDC case definitions for swine flu.
http://omniphysicians.com/2009/04/29/cdc-new-interim-swine-flu-case-definitions/

How do you treat kids and pregnant ladies for swine flu? Here is the CDC guideline.
http://omniphysicians.com/2009/04/29/treating-kids-and-pregnant-women-for-swine-flu/

Here are CDC guidelines on when to treat and prophylax for swine flu.
http://omniphysicians.com/2009/04/30/swine-flu-antiviral-treatment/

This is a FDA recall statement on Libimax. This dietary supplement contains tadalafil, an active ingredient of an FDA-approved drug for erectile dysfunction. “Boy, dieting is sure fun!”
http://omniphysicians.com/2009/04/30/recall-libimax/

Paul R.

Chvostek’s Sign and Carpopedal Spasm

Link: http://content.nejm.org/cgi/content/full/360/18/e24?query=TOC (NEJM)

A 35-year-old man presented with a 2-day history of cramps and paresthesias in the arms, predominantly involving the fingers. This presentation was preceded by a bout of viral gastroenteritis 1 week earlier. The patient reported receiving no medications and specifically reported not using thiazide diuretics. He had a blood pressure of 100/60 mm Hg, a respiratory rate of 24 breaths per minute, and carpopedal spasm, which was reproducible by inflating a blood-pressure cuff placed on the patient’s arm. Chvostek’s sign, the twitching of the circumoral muscles with tapping lightly over the facial nerve, was also present. Laboratory investigation revealed a serum calcium level of 1.9 mmol per liter (7.6 mg per deciliter) (normal range, 2.2 to 2.6 [9.0 to 10.5]), a potassium level of 2.8 mmol per liter (10.9 mg per deciliter) (normal range, 3.5 to 5.0 [13.7 to 19.5]), and a magnesium level of 0.5 mmol per liter (normal range, 0.8 to 1.2). Analysis of arterial blood gas showed a pH of 7.53, a bicarbonate level of 34 mmol per liter, and a partial pressure of carbon dioxide of 30 mm Hg. A diagnosis of hypocalcemia was made, and the patient was treated with calcium gluconate. Urinary calcium excretion was subnormal, with increased urinary loss of potassium, magnesium, and chloride, which supported the diagnosis of Gitelman’s syndrome, an inherited renal salt-wasting disorder. The patient had a good response to therapy with oral magnesium and potassium supplements.

Recall: Libimax

FDA MedWatch
Libimax, sold as a Dietary Supplement Product
Audience: Consumers, pharmacists
Nature & Health Co. and FDA notified healthcare professionals of a recall of a supplement product, Libimax. FDA analysis found the product contains tadalafil, an active ingredient of an FDA-approved drug for erectile dysfunction. This product poses a threat to health because tadalafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Consumers who have Libimax in their possession should stop using it immediately and contact their physician if they experienced any problem that may be related to taking this product.

Read the complete MedWatch 2009 Safety summary, including a link to the firm’s press release, at:

http://www.fda.gov/medwatch/safety/2009/safety09.htm#Libimax

On that kid who died…

TX Department of Health Services’ News Release
April 29, 2009

Texas Reports Swine Flu in Child from Mexico City

Swine influenza has been confirmed in a 22-month-old boy from Mexico City who died earlier this week in a Houston-area hospital. The boy, who had several underlying health problems, had traveled with his family to visit relatives in Texas.

Swine flu was confirmed in laboratory testing done by the U.S. Centers for Disease Control and Prevention in Atlanta. The Texas Department of State Health Services was notified of the finding earlier today.

Preliminary illness investigation information indicates that on April 4 the boy had traveled with his family on a commercial flight from Mexico City to Matamoros, Mexico, for a visit with relatives in Brownsville, just across the Mexico-Texas border.

The boy developed a fever on April 8 followed by other influenza-like symptoms. He was admitted to a Brownsville hospital a few days later and the next day was transferred to a Houston-area hospital by a medical transport service.

Though an illness investigation continues, state health officials said the boy would not have been infectious on the Mexico-to-Matamoros flight and that none of the boy’s known close contacts has subsequently become ill with influenza-like symptoms.

Citing personal privacy concerns for the boy’s family, medical confidentiality requirements and the absence of an obvious health threat from the boy to the public at large, state health officials declined to provide specific dates or other details at this time.

WHO speaks out on Swine Flu & Level 5

Statement by WHO Director-General, Dr Margaret Chan
29 April 2009

Swine influenza

Ladies and gentlemen,

Based on assessment of all available information, and following several expert consultations, I have decided to raise the current level of influenza pandemic alert from phase 4 to phase 5.

Influenza pandemics must be taken seriously precisely because of their capacity to spread rapidly to every country in the world.

On the positive side, the world is better prepared for an influenza pandemic than at any time in history.

Preparedness measures undertaken because of the threat from H5N1 avian influenza were an investment, and we are now benefitting from this investment.

For the first time in history, we can track the evolution of a pandemic in real-time.

I thank countries who are making the results of their investigations publicly available. This helps us understand the disease.

I am impressed by the work being done by affected countries as they deal with the current outbreaks.

I also want to thank the governments of the USA and Canada for their support to WHO, and to Mexico.

Let me remind you. New diseases are, by definition, poorly understood. Influenza viruses are notorious for their rapid mutation and unpredictable behaviour.

WHO and health authorities in affected countries will not have all the answers immediately, but we will get them.

WHO will be tracking the pandemic at the epidemiological, clinical, and virological levels.

The results of these ongoing assessments will be issued as public health advice, and made publicly available.

All countries should immediately activate their pandemic preparedness plans. Countries should remain on high alert for unusual outbreaks of influenza-like illness and severe pneumonia.

At this stage, effective and essential measures include heightened surveillance, early detection and treatment of cases, and infection control in all health facilities.

This change to a higher phase of alert is a signal to governments, to ministries of health and other ministries, to the pharmaceutical industry and the business community that certain actions should now be undertaken with increased urgency, and at an accelerated pace.

I have reached out to donor countries, to UNITAID, to the GAVI Alliance, the World Bank and others to mobilize resources.

I have reached out to companies manufacturing antiviral drugs to assess capacity and all options for ramping up production.

I have also reached out to influenza vaccine manufacturers that can contribute to the production of a pandemic vaccine.

The biggest question, right now, is this: how severe will the pandemic be, especially now at the start?

It is possible that the full clinical spectrum of this disease goes from mild illness to severe disease. We need to continue to monitor the evolution of the situation to get the specific information and data we need to answer this question.

From past experience, we also know that influenza may cause mild disease in affluent countries, but more severe disease, with higher mortality, in developing countries.

No matter what the situation is, the international community should treat this as a window of opportunity to ramp up preparedness and response.

Above all, this is an opportunity for global solidarity as we look for responses and solutions that benefit all countries, all of humanity. After all, it really is all of humanity that is under threat during a pandemic.

As I have said, we do not have all the answers right now, but we will get them.

Thank you.

Swine Flu: Antiviral Treatment

Link: http://www.cdc.gov/swineflu/recommendations.htm

Antiviral Resistance
This swine influenza A (H1N1) virus is sensitive (susceptible) to the neuraminidase inhibitor antiviral medications zanamivir and oseltamivir. It is resistant to the adamantane antiviral medications, amantadine and rimantadine.

Antiviral Treatment
Confirmed, Probable and Suspected Cases of Swine-origin Influenza A (H1N1) Virus Infection

Recommendations for use of antivirals may change as data on antiviral effectiveness, clinical spectrum of illness, adverse events from antiviral use, and antiviral susceptibility data become available.

Antiviral treatment should be considered for confirmed, probable or suspected cases of swine-origin influenza A (H1N1) virus infection. Treatment of hospitalized patients and patients at higher risk for influenza complications should be prioritized.

Only RT-PCR or viral culture can confirm infection with swine-origin influenza A (H1N1) virus. The test performance of rapid antigen tests and immunofluorescence tests for detection of swine-origin influenza A (H1N1) virus is unknown. Persons who might have swine-origin influenza A (H1N1) virus and who test positive for influenza A using one of these tests should have confirmatory RT-PCR or viral culture testing to confirm the presence of swine-origin influenza A (H1N1) virus. A negative rapid antigen or immunofluorescence test cannot be used to rule out swine-origin influenza A (H1N1) virus infection.

Antiviral treatment with zanamivir or oseltamivir should be initiated as soon as possible after the onset of symptoms. Evidence for benefits from treatment in studies of seasonal influenza is strongest when treatment is started within 48 hours of illness onset. However, some studies of treatment of seasonal influenza have indicated benefit, including reductions in mortality or duration of hospitalization even for patients whose treatment was started more than 48 hours after illness onset. Recommended duration of treatment is five days. Recommendations for use of antivirals may change as data on antiviral susceptibilities and effectiveness become available. Antiviral doses recommended for treatment of swine-origin influenza A (H1N1) virus infection in adults or children 1 year of age or older are the same as those recommended for seasonal influenza (Table 1). Oseltamivir use for children < 1 year old was recently approved by the U.S. Food and Drug Administration (FDA) under an Emergency Use Authorization (EUA), and dosing for these children is age-based (Table 2).

Note: Areas that continue to have seasonal influenza activity, especially those with circulation of oseltamivir-resistant human A (H1N1) viruses, might prefer to use either zanamivir or a combination of oseltamivir and rimantadine or amantadine to provide adequate empiric treatment or chemoprophylaxis for patients who might have human influenza A (H1N1) infection.

Antiviral Chemoprophylaxis
For antiviral chemoprophylaxis of swine-origin influenza A (H1N1) virus infection, either oseltamivir or zanamivir are recommended (Table 1). Duration of antiviral chemoprophylaxis post-exposure is 10 days after the last known exposure to an ill confirmed case of swine-origin influenza A (H1N1) virus infection. Post exposure prophylaxis should be considered for contact during the infectious period (e.g., one day before until 7 days after the case’s onset of illness). If the contact occurred more than 7 days earlier, then prophylaxis is not necessary. For pre-exposure protection, chemoprophylaxis should be given during the potential exposure period and continued for 10 days after the last known exposure to an ill confirmed case of swine-origin influenza A (H1N1) virus infection. Oseltamivir can also be used for chemoprophylaxis under the EUA (Table 3).

Antiviral chemoprophylaxis with either oseltamivir or zanamivir is recommended for the following individuals:

Household close contacts who are at high-risk for complications of influenza (e.g., persons with certain chronic medical conditions, persons 65 or older, children younger than 5 years old, and pregnant women) of a confirmed or probable case.
Health care workers or public health workers who were not using appropriate personal protective equipment during close contact with an ill confirmed, probable, or suspect case of swine-origin influenza A (H1N1) virus infection during the case’s infectious period. See guidelines on personal protective equipment.
Antiviral chemoprophylaxis with either oseltamivir or zanamivir can be considered for the following:

Household close contacts who are at high-risk for complications of influenza (e.g., persons with certain chronic medical conditions, persons 65 years or older, children younger than 5 years old, and pregnant women) of a suspected case.
Children attending school or daycare who are at high-risk for complications of influenza (children with certain chronic medical conditions) and who had close contact (face-to-face) with a confirmed, probable, or suspected case.
Health care workers who are at high-risk for complications of influenza (e.g., persons with certain chronic medical conditions, persons 65 or older, and pregnant women) who are working in an area of the healthcare facility that contains patients with confirmed swine-origin influenza A (H1N1) cases, or who is caring for patients with any acute febrile respiratory illness.
Travelers to Mexico who are at high-risk for complications of influenza (e.g., persons with certain chronic medical conditions, persons 65 or older, children younger than 5 years old, and pregnant women). (Note: A travel warning is currently in effect indicating that nonessential travel to Mexico should be avoided.
First responders who are at high-risk for complications of influenza (e.g., persons with certain chronic medical conditions, persons 65 or older, children younger than 5 years old, and pregnant women) and who are working in areas with confirmed cases of swine-origin influenza A (H1N1) virus infection.

Table 1. Swine-origin influenza antiviral medication dosing recommendations.
(Table extracted from IDSA guidelines for seasonal influenza.) Agent, group Treatment Chemoprophylaxis
Oseltamivir
Adults 75‐mg capsule twice per day for 5 days 75‐mg capsule once per day
Children (age, 12 months or older), weight: 15 kg or less 60 mg per day divided into 2 doses 30 mg once per day
15–23 kg 90 mg per day divided into 2 doses 45 mg once per day
24–40 kg 120 mg per day divided into 2 doses 60 mg once per day
>40 kg 150 mg per day divided into 2 doses 75 mg once per day

Zanamivir
Adults Two 5‐mg inhalations (10 mg total) twice per day Two 5‐mg inhalations (10 mg total) once per day
Children Two 5‐mg inhalations (10 mg total) twice per day (age, 7 years or older) Two 5‐mg inhalations (10 mg total) once per day (age, 5 years or older)

Children Under 1 Year of Age
Children under one year of age are at high risk for complications from seasonal human influenza virus infections. The characteristics of human infections with swine-origin H1N1 viruses are still being studied, and it is not known whether infants are at higher risk for complications associated with swine-origin H1N1 infection compared to older children and adults. Limited safety data on the use of oseltamivir (or zanamivir) are available from children less than one year of age, and oseltamivir is not licensed for use in children less than 1 year of age. Available data come from use of oseltamivir for treatment of seasonal influenza. These data suggest that severe adverse events are rare, and the Infectious Diseases Society of America recently noted, with regard to use of oseltamivir in children younger than 1 year old with seasonal influenza, that “…limited retrospective data on the safety and efficacy of oseltamivir in this young age group have not demonstrated age-specific drug-attributable toxicities to date.” (See IDSA guidelines for seasonal influenza.)

Because infants typically have high rates of morbidity and mortality from influenza, infants with swine-origin influenza A (H1N1) infections may benefit from treatment using oseltamivir.

Table 2. Dosing recommendations for antiviral treatment of children younger than 1 year using oseltamivir.
Age Recommended treatment dose for 5 days
<3 months 12 mg twice daily
3-5 months 20 mg twice daily
6-11 months 25 mg twice daily

Table 3. Dosing recommendations for antiviral chemoprophylaxis of children younger than 1 year using oseltamivir.
Age Recommended prophylaxis dose for 10 days
<3 months Not recommended unless situation judged critical due to limited data on use in this age group
3-5 months 20 mg once daily
6-11 months 25 mg once daily

Healthcare providers should be aware of the lack of data on safety and dosing when considering oseltamivir use in a seriously ill young infant with confirmed swine-origin H1N1 influenza or who has been exposed to a confirmed swine H1N1 case, and carefully monitor infants for adverse events when oseltamivir is used. See additional information on oseltamivir for this age group.

Pregnant Women
Oseltamivir and zanamivir are “Pregnancy Category C” medications, indicating that no clinical studies have been conducted to assess the safety of these medications for pregnant women. Because of the unknown effects of influenza antiviral drugs on pregnant women and their fetuses, oseltamivir or zanamivir should be used during pregnancy only if the potential benefit justifies the potential risk to the embryo or fetus; the manufacturers’ package inserts should be consulted. However, no adverse effects have been reported among women who received oseltamivir or zanamivir during pregnancy or among infants born to women who have received oseltamivir or zanamivir. Pregnancy should not be considered a contraindication to oseltamivir or zanamivir use. Because of its systemic activity, oseltamivir is preferred for treatment of pregnant women. The drug of choice for prophylaxis is less clear. Zanamivir may be preferable because of its limited systemic absorption; however, respiratory complications that may be associated with zanamivir because of its inhaled route of administration need to be considered, especially in women at risk for respiratory problems.

Adverse Events and Contraindications
For further information about influenza antiviral medications, including contraindications and adverse effects, please see the following:

Antiviral Agents for Seasonal Influenza: Side Effects and Adverse Reactions
MMWR: Prevention and Control of Influenza: Recommendations of the Advisory Committee on Immunization Practices (ACIP), 2008
MMWR August 8, 2008 / 57(RR07);1-60
Adverse events from influenza antiviral medications should be reported through the U.S. FDA Medwatch website.

91 cases

CDC, 4/30/09 update:

The outbreak of disease in people caused by a new influenza virus of swine origin continues to grow in the United States and internationally. Today, CDC reports additional confirmed human infections, hospitalizations and the nation’s first fatality from this outbreak. The more recent illnesses and the reported death suggest that a pattern of more severe illness associated with this virus may be emerging in the U.S. Most people will not have immunity to this new virus and, as it continues to spread, more cases, more hospitalizations and more deaths are expected in the coming days and weeks.

CDC has implemented its emergency response. The agency’s goals are to reduce transmission and illness severity, and provide information to help health care providers, public health officials and the public address the challenges posed by the new virus. Yesterday, CDC issued new interim guidance for clinicians on how to care for children and pregnant women who may be infected with this virus. Young children and pregnant women are two groups of people who are at high risk of serious complications from seasonal influenza. In addition, CDC’s Division of the Strategic National Stockpile (SNS) continues to send antiviral drugs, personal protective equipment, and respiratory protection devices to all 50 states and U.S. territories to help them respond to the outbreak. The swine influenza A (H1N1) virus is susceptible to the prescription antiviral drugs oseltamivir and zanamivir. This is a rapidly evolving situation and CDC will provide updated guidance and new information as it becomes available.

As of 11:00 AM ET on April 29, 2009, CDC has confirmed 91 human cases of swine flu in 10 states and 1 death:

Arizona: 1
California: 14
Indiana: 1
Kansas: 2
Massachusetts: 2
Michigan: 2
Nevada: 1
New York: 51
Ohio: 1
Texas: 16 (1 death)
This information has recently been updated,

Treating Kids and Pregnant Women for Swine Flu

CDC Health Update: Interim Guidance—Children and Pregnant Women who may be Infected with Swine-Origin Influenza Virus: Considerations for Clinicians
Distributed via Health Alert Network
April 28, 2009 23:45 EST (11:45 PM EST)
CDCHAN-00285-09-04-28-UPD-N

Today CDC issued new interim guidance for clinicians on how to care for children and pregnant women who may be infected with a new influenza virus of swine origin that is spreading in the U.S. and internationally. Children and pregnant women are two groups of people who are at high risk of serious complications from seasonal influenza.

New Interim Clinical Guidance for the Treatment of Children
Little is currently known about how swine-origin influenza viruses (S-OIV) may affect children. However, we know from seasonal influenza and past pandemics that young children, especially those younger than 5 years of age and children who have high risk medical conditions, are at increased risk of influenza-related complications.

Illnesses caused by influenza virus infection are difficult to distinguish from illnesses caused by other respiratory pathogens based on symptoms alone. Young children are less likely to have typical influenza symptoms (e.g., fever and cough) and infants may present to medical care with fever and lethargy, and may not have cough or other respiratory symptoms or signs.

The new interim guidance for clinicians on the prevention and treatment of swine influenza in young children is available at http://www.cdc.gov/swineflu/childrentreatment.htm

New Interim Clinical Guidance for the Treatment of Pregnant Women
Evidence that influenza can be more severe in pregnant women comes from observations during previous pandemics and from studies among pregnant women who had seasonal influenza. An excess of influenza-associated deaths among pregnant women were reported during the pandemics of 1918–1919 and 1957–1958. Adverse pregnancy outcomes have been reported following previous influenza pandemics, with increased rates of spontaneous abortion and preterm birth reported, especially among women with pneumonia. Case reports and several epidemiologic studies conducted during interpandemic periods also indicate that pregnancy increases the risk for influenza complications for the mother and might increase the risk for adverse perinatal outcomes or delivery complications.

The new interim guidance for clinicians for the treatment of influenza in pregnant women is available at http://www.cdc.gov/swineflu/clinician_pregnant.htm

Background
Human infections with the newly identified S-OIV that is spreading among humans were first identified in April 2009 with cases in the United States and Mexico. The epidemiology and clinical presentations of these infections are currently under investigation. There are insufficient data available at this point to determine who is at higher risk for complications of S-OIV infection. However because pregnant women and children are known to be at higher risk for complications during seasonal influenza complications and during prior pandemics, it is reasonable to assume that these groups of people may be at higher risk for complications from infection with this new virus.

Additional Information
For additional information about the current influenza outbreak, see:
http://www.cdc.gov/swineflu/

For additional information about CDC’s investigation of the current H1N1 outbreak, see http://www.cdc.gov/swineflu/investigation.htm

This information is also available by calling 1-800-CDC-INFO.

CDC: New Interim Swine Flu Case Definitions

Interim Guidance on Case Definitions to be Used For Investigations of Swine Influenza A (H1N1) Cases*
April 29, 2009 2:00 AM ET

This document provides interim guidance for state and local health departments conducting investigations of human cases of swine-origin influenza A (H1N1) virus (S-OIV). The following case definitions are for the purpose of investigations of suspected, probable, and confirmed cases of S-OIV infection.

Acute febrile respiratory illness is defined as a measured temperature of 37.8 degrees Celsius (100.4 degrees Fahrenheit) and recent onset of at least one of the following: rhinorrhea or nasal congestion, sore throat, or cough.

Case Definitions for Infection with Swine-origin Influenza A (H1N1) Virus (S-OIV)
A confirmed case of S-OIV infection is defined as a person with an acute febrile respiratory illness with laboratory confirmed S-OIV infection at CDC by one or more of the following tests:

real-time RT-PCR
viral culture
A probable case of S-OIV infection is defined as a person with an acute febrile respiratory illness who is positive for influenza A, but negative for H1 and H3 by influenza RT-PCR

A suspected case of S-OIV infection is defined as a person with acute febrile respiratory illness with onset

within 7 days of close contact with a person who is a confirmed case of S-OIV infection, or
within 7 days of travel to community either within the United States or internationally where there are one or more confirmed cases of S-OIV infection, or
resides in a community where there are one or more confirmed cases of S-OIV infection.

OMNI Postings of 4/29/09

A woman went to her priest with a problem. “Father, I have two female parrots, and they only know how to say one thing. All they ever say is, ‘Hi, we’re prostitutes. Wanna have some fun?’ ”

“That’s terrible!” exclaimed the priest. “But I think I can help. Bring your two female parrots over to my house, and I will put them with my two male parrots whom I taught to pray and read the Bible. My parrots will teach your parrots to stop saying that terrible phrase, and your female parrots will learn to praise and worship.”

The next day, the woman brought her female parrots to the priest’s house. His two male parrots were holding rosary beads and quietly praying in their cage. The woman put her two female parrots in the cage with the male parrots. The females said, “Hi, we’re prostitutes. Wanna have some fun?”

One male parrot looked over at the other male parrot and exclaimed “Put those beads away, our prayers have been answered!”

But I digress….

Here is the latest MMWR dispatch about swine flu.
http://omniphysicians.com/2009/04/29/mmwr-dispatch-april-28-2009-58dispatch1-3-swine-flu-update/

There’s been 1 US death, but it’s my understanding that the baby was ill in Mexico and transferred to TX for care. We’re up to about 64 confirmed cases now. OH still has only 1, but I’m optimistic.
http://omniphysicians.com/2009/04/29/swine-flu-first-us-death/

In case you were waiting on line at the pharmacy, it’ll take months for a swine flu vaccine to be created. And then you’ll get Guillain-Barre’. You won’t be able to wipe your nose, but that’s OK…you won’t be sneezing anyway.
http://omniphysicians.com/2009/04/29/swine-flu-vaccine/

The FDA wants new labeling for OTC acetominophen and NSAIDS like liver damage and GI bleeding.
http://omniphysicians.com/2009/04/28/fda-new-labeling-for-nsaids-tylenol/

This study from Arch Intern Med concludes that having a pharmacist by your side will reduce medication errors. Not only is there Big Brother. There’s Big Uncle…Big Cousin and all the other little Big Pains-in-the Ass.
http://omniphysicians.com/2009/04/28/pharmacist-intervention/

Paul R

MMWR Dispatch (April 28, 2009 / 58(Dispatch);1-3): Swine Flu Update

Update: Infections With a Swine-Origin Influenza A (H1N1) Virus — United States and Other Countries, April 28, 2009

Since April 21, 2009, CDC has reported cases of respiratory infection with a swine-origin influenza A (H1N1) virus (S-OIV) transmitted through human-to-human contact (1,2). This report updates cases identified in U.S. states and highlights certain control measures taken by CDC. As of April 28, the total number of confirmed cases of S-OIV infection in the United States had increased to 64, with cases in California (10 cases), Kansas (two), New York (45), Ohio (one), and Texas (six). CDC and state and local health departments are investigating all reported U.S. cases to ascertain the clinical features and epidemiologic characteristics. On April 27, CDC distributed an updated case definition for infection with S-OIV (Box).

Of the 47 patients reported to CDC with known ages, the median age was 16 years (range: 3–81 years), and 38 (81%) were aged <18 years; 51% of cases were in males. Of the 25 cases with known dates of illness onset, onset ranged from March 28 to April 25 (Figure). To date, no deaths have been reported among U.S. cases, but five patients are known to have been hospitalized. Of 14 patients with known travel histories, three had traveled to Mexico; 40 of 47 patients (85%) have not been linked to travel or to another confirmed case. Information is being compiled regarding vaccination status of infected patients, but is not yet available. According to the World Health Organization (WHO), as of April 27, a total of 26 confirmed cases of S-OIV infection had been reported by Mexican authorities. Canada has reported six cases and Spain has reported one case.*

Emergency Use Authorizations

If an emerging public health threat is identified for which no licensed or approved product exists, the Project BioShield Act of 2004 authorizes the Food and Drug Administration (FDA) commissioner to issue an Emergency Use Authorization (EUA) so that promising countermeasures can be disseminated quickly for the protection and safety of the U.S. population (3).

In response to the current public health emergency involving swine-origin influenza, FDA issued four EUAs on April 27 to allow emergency use of

oseltamivir (Tamiflu) and zanamivir (Relenza) for the treatment and prophylaxis of influenza (two EUAs),
disposable N95 respirators for use by the general public, and
the rRT-PCR Swine Flu Panel for diagnosis.
Oseltamivir is FDA-approved for treatment and prevention of influenza in adults and children aged ≥1 year. Zanamivir is FDA-approved for treatment of influenza in adults and children aged ≥7 years who have been symptomatic for <2 days, and for prevention of influenza in adults and children aged ≥5 years. The EUA allows the use of oseltamivir for treatment of influenza in children aged <1 year and prevention of influenza in children aged 3 months–1 year. Additionally, traditional prescribing and dispensing requirements might not be met. Under the scope and conditions of current EUAs, mass dispensing of both antiviral medications will be allowed per state and/or local public health authority.

FDA has authorized use of certain N95 respirators to help reduce wearer exposure to pathogenic biological airborne particulates during a public health emergency involving S-OIV. On April 27, CDC published guidelines for the use of N95 respirators. For example, respirators should be considered for use by persons for whom close contact with an infectious person is unavoidable. This can include selected individuals who must care for a sick person (e.g., family member with a respiratory infection) at home. Additional information is available at http://www.cdc.gov/swineflu/masks.htm.

Currently, no FDA-cleared tests specifically for the S-OIV strain exist in the United States or elsewhere. For this purpose and to meet the significant increase in demand for influenza testing throughout the country, CDC has developed the rRT-PCR Swine Flu Panel to expand and maintain the operational capabilities of public health or other qualified laboratories by providing a detection tool for the presumptive presence of S-OIV.

Control Measures at Ports of Entry and Travel Warning for Mexico

CDC, in collaboration with industry and federal partners, is continuing to conduct routine illness detection at ports of entry with heightened awareness for travelers who might be infected with S-OIV. During April 19–27, 15 cases of illness in travelers entering the United States from Mexico that were clinically consistent with S-OIV infection were detected. Of these 15 cases, two were laboratory confirmed as swine-origin influenza A (H1N1). Nine travelers remain in isolation pending completion of evaluation, and four travelers were released to complete travel after influenza virus infection was ruled out.

WHO has declared a Public Health Emergency of International Concern. As part of its responsibilities under the International Health Regulations, CDC is prepared to implement additional screening measures for international flights, if deemed necessary, to prevent exportation of S-OIV. In addition, CDC in collaboration with the U.S. Department of Homeland Security, is distributing travelers health alert notices to all persons traveling to countries with confirmed cases of S-OIV infection.

CDC has recommended that U.S. travelers avoid nonessential travel to Mexico (http://wwwn.cdc.gov/travel/contentswineflumexico.aspx). However, CDC might revise its travel guidance as the outbreak in Mexico evolves and is characterized more completely. Travelers who cannot delay travel to Mexico should visit http://www.cdc.gov/travel and follow the posted recommendations to reduce their risk for infection.

Nonpharmaceutical Community Mitigation

CDC has issued interim guidance for nonpharmaceutical community mitigation efforts in response to human infections with S-OIV (http://www.cdc.gov/swineflu/mitigation.htm). Current recommendations for isolation of patients with cases of S-OIV, household contacts, school dismissal, and other social distancing interventions also are available at http://www.cdc.gov/swineflu/mitigation.htm and will be updated as the situation evolves.

Reported by: Strategic Science and Program Unit, Coordinating Center for Infectious Diseases; Div of Global Migration and Quarantine, National Center for Preparedness, Detection, and Control of Infectious Diseases; Influenza Div, National Center for Immunization and Respiratory Diseases, CDC Influenza Emergency Response Team, CDC.

References

CDC. Swine influenza A (H1N1) infection in two children—southern California, March–April 2009. MMWR 2009;58:400–2.
CDC. Update: swine influenza A (H1N1) infections—California and Texas, April 2009. MMWR;58(In press).
Nightingale SL, Prasher JM, Simonson S. Emergency Use Authorization (EUA) to enable use of needed products in civilian and military emergencies, United States. Emerg Infect Dis 2007;13:1046–51.
* Additional information is available at http://www.who.int/en.

BOX. CDC interim guidance on case definitions for investigations of human swine-origin influenza A (H1N1) cases

The following case definitions are for the purposes of investigations of suspected, probable, and confirmed cases of swine-origin influenza A (H1N1) infection.

Case Definitions for Infection with Swine-Origin Influenza A (H1N1) Virus

A confirmed case of swine-origin influenza A (H1N1) virus infection is defined as an acute febrile respiratory illness in a person and laboratory-confirmed swine-origin influenza A (H1N1) virus infection at CDC by either of the following tests:

1) real-time reverse transcrition–polymerase chain
reaction (rRT-PCR), or

2) viral culture.

A probable case of swine-origin influenza A (H1N1) virus infection is defined as acute febrile respiratory illness in a person who is

• positive for influenza A, but negative for H1 and H3 by influenza rRT-PCR.

A suspected case of swine-origin influenza A (H1N1) virus infection is defined as acute febrile respiratory illness in a person

• with onset within 7 days of close contact with a person who has a confirmed case of swine-origin influenza A (H1N1) virus infection, or

• with onset within 7 days of travel to a community, either within the United States or internationally, which has one or more confirmed swine-origin influenza A (H1N1) cases, or

• who resides in a community in which one or more confirmed swine-origin influenza cases have occurred.

W135 & MCV4 that protects against the W135 strain

Link: http://www.miamiherald.com/news/miami-dade/breaking-news/story/1014168.html

Miami Herald, 4/23/09:
Miami-Dade health officials said Thursday that they’re ‘’stumped” in efforts to understand the cause and course of 12 cases of a rare, virulent form of meningitis that has killed four people in South Florida since December.

The strain, W135, makes up only about 3 percent of cases worldwide. It’s unusual to have so many in one grouping here, said Dr. Vincent Conte, senior physician at the Miami-Dade Health Department.

”There doesn’t seem to be any pattern,” he said. “We have cases in North Dade, South Dade, East Dade and West Dade. There’s no real cluster. It’s everywhere.”

The strain is surprising, Conte said. “There have been scattered outbreaks around the world over the past few years, but so far in the U.S. we’re the first location where there has been a cluster.”

Conte said the county is working with epidemiologists from the state Department of Health to investigate the infections. Experts from the U.S. Centers for Disease Control and Prevention are also monitoring the situation, but the outbreak has not yet reached a level at which the CDC would send experts to South Florida.

At a hastily called news conference Wednesday, county health officials first disclosed the incidences of the disease and advised that anyone with symptoms — severe headache, fever, nausea, vomiting, stiff neck — see a doctor immediately or visit emergency rooms if they can’t see their own doctor the same day.

Conte said the health department has sent health advisories to doctors and hospitals around South Florida warning them to watch out for patients with those symptoms as well.

”We’ve had quite a few calls from residents and from doctors,” he said. No new cases have surfaced since Wednesday.

Conte said people worried about meningitis can get a vaccine, called MCV4, that protects against the W135 strain. It’s a vaccination routinely recommended by the CDC for youths reaching the age of 11 or 12. But it’s not required for public school attendance, so he didn’t know what percentage of South Florida children have taken it.

The vaccination protects adults as well, he said. It takes about a week after the shot for the body to create antibodies against the disease, he said.

He recommended it particularly for college students, military recruits and others living or working in crowded situations. The disease is spread by kissing, coughing and touching surfaces touched by those who are infected.

It’s not the same vaccination as the Hib meningitis shot that is required for entrance to kindergarten in public schools, he said. That shot does not protect against this strain of meningitis, he said.

A British website, thisisnottingham.co.uk, identified one of the people who had died as Jade Thomas, a school teacher from Nottingham in the United Kingdom.

The story said she died of meningitis while on vacation in Florida to celebrate her 26th birthday….

According to the Miami-Dade medical examiner’s office, Thomas, 26, died in the emergency room at Mt. Sinai Hospital on April 7. Her body was brought to the medical examiner’s office for an autopsy. Her cause of death has not yet been determined, according to the medical examiner’s office….

OSMA & Swine Flu

Case of Swine Flu Confirmed in Ohio: How to Get the Information You Need

Sunday, a 9-year-old boy from Lorain County was confirmed as having a mild case of swine flu. The Lorain County boy and his family recently visited Mexico. Soon after returning, he developed upper-respiratory problems, a sore throat and a fever that reached 103 degrees.

As of 11 a.m. on Tuesday, 64 cases of the swine flu were confirmed in the U.S., with 45 in New York City. Ohio is one of only five states to have confirmed cases at this time.

The Centers for Disease Control and Prevention (CDC) is providing several resources, including guidance for physicians. It is also updating the number of confirmed cases by state. To access this valuable information, please visit the CDC Web site by clicking here.

The Ohio Dept of Health has also established a toll-free information line for Ohioans with questions about swine flu. Please call 866-800-1404 between 8 a.m. and 5 p.m. Monday through Friday.

Recall: Certain nail-polish removers. Chemical burn dangers.

FDA Recall — Firm Press Release
FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

Personal Care Products Conducts Nationwide Recall of Non-Acetone Nail Polish Remover Because of Possible Health Risk
Contact:
Lawrence Weisberg
248-258-1555

FOR IMMEDIATE RELEASE — April 29, 2009 — Personal Care Products of Bingham Farms, MI is voluntarily conducting a nationwide recall of all lots of Personal Care non-acetone nail polish remover, conditioner enriched with gelatin, 6 fl. oz., UPC 4815592076, because it does not meet product specifications and has the potential to cause chemical burns to the fingers of users.

The product has been sold nationwide in small discount retail stores and retailers are being instructed to remove the product from sale and to return it to Personal Care Products.

Personal Care has received two complaints of burns to the fingers resulting from the use of the product.

Any person who purchased a bottle of Personal Care non-acetone nail polish remover, conditioner enriched with gelatin is urged to return it to the store of purchase for a refund. Consumers with questions may contact Personal Care Products at 1-248-258-1555, Monday through Friday from 9 a.m. until 5 p.m. EDT.

Swine Flu: First U.S. death

LA Times, 4/29/09
First U.S. Swine Flu fatality…..a 23 month old toddler!

http://www.latimes.com/la-sci-flu-death30-2009apr30,0,4966691.story

Swine flu kills first victim in U.S.
The CDC says a 23-month-old child in Texas has died. ‘My heart goes out to the family,’ acting director says.
By Mark Silva
4:46 AM PDT, April 29, 2009
Reporting from Washington — The swine flu outbreak has claimed its first victim in the United States, according to the Centers for Disease Control and Prevention: A 23-month-old child in Texas.
Dr. Richard Besser, acting director of the CDC, confirmed the fatality in an appearance this morning on NBC’s “Today” show.

With 64 confirmed cases of the disease nationwide according to the agency’s latest accounting – including 45 in New York City – the agency says it’s too soon to say how fast the flu is spreading.
Health authorities had anticipated the first U.S. death after the disease was suspected in the deaths of more than 150 people in Mexico, where the outbreak is believed to have begun. Yet the death of the toddler in Texas is tragic, Besser said.

“As a pediatrician and a parent, my heart goes out to the family,” Besser said.

The flu case in Texas was one of six that had been confirmed in the U.S. in addition to 10 in California, 2 in Kansas and one in Ohio, according to the CDC’s accounting Tuesday. In addition, other reports of illnesses from Chicago to New York have raised the possibility that the number of cases will continue to climb.