HEALTH

Swine flu may increase demands for POC flu tests

BY Michael Johnsen

NEW YORK The current situation with a possible swine flu pandemic may increase demand for rapid point-of-care flu tests, tests that would ascertain whether or not a person was ill with a traditional flu as opposed to the swine flu, market research publisher Kalorama asserted Monday.

“Although there is no marketed POC test specifically for the A/H1N1 [swine] strain at this point, it is likely common flu tests on the market will see increased usage,” stated Bruce Carlson, publisher of Kalorama Information. “Physicians will feel an urgency to determine if a patient simply has the more common flu, and given the circumstances, they may not want to wait for central lab testing. POC tests are also more effective when patients see the doctor earlier, as they are likely to do when they hear of the epidemic, or crisis.”

The influenza rapid testing market has morphed from an experimental area with a few products, into a considerable component of the entire point-of-care infectious disease market, which Kalorama Information values at over $500 million annually in its new report “World Markets for Point of Care Diagnostics.”

Quidel leads the market for influenza testing with its Rapid Vue product, a rapid chromatographic immunoassay which provides results in 10 minutes from a sample collected via a nose or throat swab. Competitors in influenza testing include Becton Dickinson’s Directigen EZ Flu A+B test, Inverness Medical’s Biax Now and Meridan Biosciences TRU FLU.

In a conference call held Tuesday, Becton Dickinson noted that there has not yet been any increase in demand for its influenza diagnostics.

“The type of products that you can expect to be potentially in higher demand [during a pandemic event], although we’re not necessarily seeing much of it yet, would be rapid flu tests where there’s already an increased demand as you might expect from Mexico,” stated Gary Cohen, BD EVP. “That’s not a large business for us but the demand is already going up. And also immunization devices that would accompany either injectable antivirals or immunizations for the flu strain as injectables are developed, as flu vaccine is developed around these strains.”

Prior to this weekend, point-of-care influenza diagnostics had not been doing well, Kalorama acknowledged.

“All of these companies reported first quarter test sales were down as the result of a weak flu season this winter. It’s probable that this outbreak will boost revenues for these companies, and the stock market has already reacted to this possibility,” the company stated.

Carlson added, “In a crisis atmosphere like this, the benefit of ‘knowing now’ that point-of-care provides is made clear. This could be an important showcase of the need for faster testing, and that is critical for the long-term success of POC testing products in all of infectious disease.”

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FDA to require NSAID manufacturers to revise labeling

BY Michael Johnsen

ROCKVILLE, Md. The Food and Drug Administration issued a final rule Tuesday that requires manufacturers of over-the-counter pain relievers and fever reducers to revise their labeling to include warnings about potential safety risks, such as internal bleeding and liver damage, associated with the use of these drugs.

Products covered by the FDA action include acetaminophen, and a class of drugs known as the nonsteroidal anti-inflammatory drugs. NSAIDs include aspirin, ibuprofen, naproxen and ketoprofen.

The revised labeling applies to all OTC pain relievers and fever reducers, including those that contain one of these ingredients in combination with such other ingredients, as cold medicines containing pain relievers or fever reducers.

“Acetaminophen and NSAIDs are commonly used drugs for both children and adults because they are effective in reducing fevers and relieving minor aches and pain, such as headaches and muscle aches, “ stated Charles Ganley, director of FDA’s Office of Nonprescription Drugs in the Center for Drug Evaluation and Research. “However, the risks associated with their use need to be clearly identified on the label so that consumers taking these drugs are fully aware of the potential harm they can cause. It is important that they know how to take these medications safely to reduce their risk.”

Under the final rule, manufacturers must ensure that the active ingredients of these drugs are prominently displayed on the drug labels on both the packages and bottles. The labeling also must warn of the risks of stomach bleeding for NSAIDs and severe liver damage for acetaminophen.

The new rule requires all manufacturers to relabel their products by April 28, 2010.

However, many analgesic manufacturers are already in compliance with the new labeling rules, Barbara Kochanowski, VP regulatory affairs for the Consumer Healthcare Products Association, stated Tuesday.

“CHPA member companies voluntarily have begun implementing many of the label changes included in the final rule that will publish April 29, 2009, well ahead of the April 28, 2010, implementation deadline,” she said. “These label changes are designed to provide consumers with a greater understanding of some of the risks that could be associated with the misuse of these medications.”

An FDA Advisory Committee meeting will convene on June 29 and 30 to discuss further steps the FDA could take to reduce the risk of liver damage associated with acetaminophen overdoses.

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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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