US Federal drug regulators warned consumers to stop using Zicam, a popular homeopathic cold remedy, because it could damage or destroy their sense of smell.
The action is an early indication that the administration of US President Barack Obama is likely to take far more aggressive enforcement actions against drug companies than the previous administration did.
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.
In 2006, Matrixx paid US$12 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 administration of former US president George W. Bush, Margaret Hamburg, who was named the agency commissioner by Obama, said the incidence of anosmia associated with Zicam “strikes us as a fairly large problem.”
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 had suspended shipments of Zicam and would reimburse customers who wanted a refund.
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.
Matrixx has received more than 800 reports of Zicam users losing their sense of smell but did not provide those reports to the FDA, the agency said.
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