HEALTH

CDC updates proposed treatment course for swine flu

BY Michael Johnsen

ATLANTA The Centers for Disease Control and Prevention on Tuesday updated its proposed treatment course for any patient expected of having been exposed to the swine flu.

Either Tamiflu (oseltamivir) or Relenza (zanamivir) are recommended for up to 10 days after the last known exposure to a confirmed case of swine influenza A (H1N1) virus infection.

For pre-exposure protection, antivirals should be given during the potential exposure period and continued for 10 days after the last known exposure to a confirmed case of swine influenza A (H1N1) virus infection.

Antiviral used as a preventitive (pre-exposure or post-exposure) 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, probable or suspected case;
  • School children who are at high-risk for complications of influenza (children with certain chronic medical conditions) who had close contact (face-to-face) with a confirmed, probable or suspected case;
  • 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);
  • Healthcare 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 influenza A (H1N1) virus infection during the case’s infectious period.

Pre-exposure antiviral used as a preventatitive with either oseltamivir or zanamivir can be considered for the following:

  • Any health care worker who is 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) who is working in an area of the healthcare facility that contains patients with confirmed swine influenza A (H1N1) cases, or who is caring for patients with any acute feverish respiratory illness;
  • Non-high risk persons who are travelers to Mexico, first responders or border workers who are working in areas with confirmed cases of swine influenza A (H1N1) virus infection.

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 H1N1 viruses are still being studied, and it is not known whether infants are at higher risk for complications associated with swine 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 young than one-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.”

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

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 H1N1 influenza or who has been exposed to a confirmed swine H1N1 case, and carefully monitor infants for adverse events when oseltamivir is used.

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 zanamivir is an inhaled medication and has less systemic absorption, some experts prefer zanamivir over oseltamivir for use in pregnant women when feasible.

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Obama administration mobilizes flu meds, declares public health emergency

BY Michael Johnsen

WASHINGTON The Obama administration mobilized government stockpiles of flu medicines Sunday afternoon, declaring a public health emergency, following an update from the Centers for Disease Control and Prevention earlier in the morning that confirmed 20 U.S. cases of swine flu to date.

“President [Barack] Obama is very concerned about the recent cases of swine flu that have been identified in the United States, as well as the outbreak in Mexico,” stated John Brennan, assistant to the President for Homeland Security and Counterterrorism, during a special press conference Sunday afternoon. “At this point a top priority is to ensure that communication is robust and that medical surveillance efforts are fully activated. This will enable both the rapid identification and broad notification of any new cases that may occur in the U.S., as well as in Mexico.”

A public health emergency was declared by the Department of Health and Human Services as a way to free up federal, state, and local agencies and their resources for prevention and mitigation. “It allows us to use medication and diagnostic tests that we might not otherwise be able to use, particularly on very young children; and it releases funds for the acquisition of additional antivirals,” Janet Napolitano, the Secretary of Homeland Security, told reporters Sunday.

The government currently has approximately50 million treatment courses of antiviral drugs — Tamiflu and Relenza — in the strategic national stockpile, Napolitano said. “We are releasing 25% of those courses, making them available to all of the states, but particularly prioritizing the states where we already have confirmed incidents of the flu. In addition, the Department of Defense has procured and strategically prepositioned 7 million treatment courses of Tamiflu.”

The government expects the number of swine-flu related cases to grow from the initial 20 identified so far.

“As we look for cases of swine flu, we are seeing more cases of swine flu,” stated Richard Besser, acting director of the CDC. “We expect to see more cases of swine flu.”

In New York City, where there’s been a cluster of swine-flu related disease in a school, that school has been closed for Monday, Besser reported.

“There’s a similar situation in Texas,” he said. “If there are other communities where we saw cases in a school, we would be recommending that they take those actions as well.”

Besser noted that the swine flu outbreak in the United States has been relatively mild — of the 20 cases identified, 19 have recovered and only one person has been hospitalized.

“What we know about this virus is it looks to be the same virus as is causing the situation in Mexico. And given the reports out of Mexico, I would expect that over time we’re going to see more severe disease in this country,” Besser cautioned.

As part of its response, CDC is already moving forward on the possible development of a vaccine.

“We’ve created that seed stock, we’ve identified that virus, and discussions are underway so that should we decide to work on manufacturing a vaccine, we can work towards that goal very quickly,” Besser said.

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Home Diagnostics’ TRUE2go receives design award

BY Michael Johnsen

FORT LAUDERDALE, Fla. Home Diagnostics on Monday announced that the company’s TRUE2go blood glucose meter was awarded a Medical Design Excellence Award.

“Our team is honored to be recognized for our commitment to innovation and design with a Medical Design Excellence Award for TRUE2go,” stated Joe Capper, president and CEO of Home Diagnostics. “This award is a testament to the dedication of the Home Diagnostics team for creating products that deliver outstanding performance and value while helping people with diabetes manage their disease in a way that fits their individual lifestyles.”

The MDEA competition recognizes the achievements of medical product manufacturers responsible for the innovations that are changing the face of healthcare. Small enough to twist and attach to the top of a vial of test strips, TRUE2go delivers precise results in as fast as four seconds using only 0.5 microliters of blood. In clinical testing, TRUE2go achieved a high degree of accuracy and repeatability, and was considered easy to use. TRUE2go uses the company’s new TRUEtest platform of blood glucose test strips featuring the company’s patent-pending GoldSensor laser accuracy and TRUEfill beveled tip, which ensures highly accurate test results and first test success.

The 2009 Medical Design Excellence Award winners will be honored at a ceremony during the Medical Design & Manufacturing East Conference and Exposition, June 9-11, 2009, at New York City’s Jacob K. Javits Convention Center.

TRUE2go is available at retailers nationwide for only $9.99 in many retail locations.

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