Image via WikipediaLate post, and just about catching up, because this one is important as well as the rest…
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THE NEW YORK TIMES
05:55 AM Jun 18, 2009
NEW YORK - Federal drug regulators have warned consumers to stop using Zicam, a popular homeopathic cold remedy, because it could damage or destroy their sense of smell.
The Food and Drug Administration (FDA) received 130 reports from consumers and doctors of people losing their sense of smell after using one of the Zicam nasal products, which include Zicam Cold Remedy and Zicam Cold Remedy Swabs. The reports date to 1999, when Matrixx Initiatives of Scottsdale, Arizona, first introduced the products.
The agency issued its consumer alert even though Matrixx refused to recall its products, a highly unusual event.
In a news release, Matrixx said it "stands behind the science of its products" and was seeking a meeting with the FDA, although it suspended shipments of Zicam and would reimburse customers who wanted a refund.
The FDA action is an early indication that the Obama administration is likely to take far more aggressive enforcement actions against drug companies than the Bush administration did.
The FDA does not have the power to order product recalls but must rely on manufacturers to do so voluntarily. Bills now moving through Congress would give the agency that power. Bush administration appointees said the FDA did not need mandatory recall authority because companies always withdrew unsafe products when asked.
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RESERVE for cell restoration
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In 2006, Matrixx paid US$12 million ($17.5 million) to settle 340 lawsuits from Zicam users who claimed that the product destroyed their sense of smell, a condition known as anosmia. Hundreds more such suits have since been filed.
Although the FDA took no action during the Bush administration, Dr Margaret Hamburg, who was named the agency commissioner by President Barack Obama, said the incidence of anosmia associated with Zicam "strikes us as a fairly large problem".
Matrixx had US$101 million in sales last year, of which US$40 million came from Zicam products. Because Matrixx has called Zicam a homeopathic product, the company was not required to seek agency approval before selling it.
An FDA warning letter sent to Matrixx on Tuesday stated that Zicam Cold Remedy intranasal products "may pose a serious risk to consumers who use them" and are "misbranded". Such language would normally describe a recall alert. The products have no proven benefits.
Matrixx has received more than 800 reports of Zicam users losing their sense of smell but did not provide those reports to the FDA, said Ms Deborah Autor, director of compliance in the agency's drug centre.
From TODAY, World – Thursday, 18-Jun-2009; see the source article here.
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