HEALTH

Nature & Health Co. announces voluntary, natiowide recall

BY Michael Johnsen

BREA, Calif. Nature & Health Co. on Tuesday announced that it is conducting a voluntary nationwide recall of the company’s supplement product sold under the name Libimax after being informed by representatives of the Food and Drug Administration that Libimax samples could contain tadalafil, the active ingredient in Lilly’s prescription-only erectile dysfunction drug Cialis.

The product is distributed through vitamin stores, grocery stores and liquor stores, according to the company’s Web site.

FDA advised that this poses a threat to consumers because tadalafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. According to the FDA, consumers with diabetes, high blood pressure, high cholesterol or heart disease often take nitrates.

FDA advises that ED is a common problem in men with these conditions, and they may seek products to enhance sexual performance. FDA advises that tadalafil, may cause side effects, such as headaches and flushing.

The recalled Libimax is sold as a 1 capsule individual pack or 10-capsule and 20-capsule plastic bottles in retail stores in California, Georgia, Illinois, Texas and Ohio.  The product label neither states it contains tadalafil nor warns consumers with high blood pressure not to ingest the product.

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Pain-reliever removed from AAFES retailers

BY Michael Johnsen

DALLAS Army & Air Force Exchange Service retailers are removing aspirin from their shelves per a Department of Defense mandate.

AAFES is removing the analgesic from its pain-reliever lineup in an effort to reduce blood loss in the event of an injury for those soldiers operating in combat zones.

According to the memorandum from the Assistant Secretary of Defense, aspirin in combat zones is to be controlled. Furthermore, the memo states that “there should be no over-the-counter access through AAFES outlets or other Morale, Welfare and Recreation activities.”

All personnel, military and civilian, deploying to a combat zone are advised to stop taking aspirin at least 10 days prior to departure, unless advised by their healthcare provider to continue use, AAFES stated.

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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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