Zicam Recalled for Dangerous Effects

Yesterday, the Food and Drug Administration (FDA) warned consumers to stop using Zicam, a popular homeopathic cold remedy, because it could damage or destroy their sense of smell, a condition called anosmia.
The Food and Drug Administration 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, Ariz., first introduced the products.
The FDA issued its consumer alert even though Matrixx refused to recall its products. In a news release, Matrixx said it had suspended shipments of Zicam and would reimburse customers who wanted a refund.
Matrixx had $101 million in sales last year, of which $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.
Under current law, the FDA. does not have the authority to order product recalls but must rely on manufacturers to do so voluntarily. Bills have been introduced in Congress would give the agency recall power.
This action by the FDA is hopefully a signal that the Obama administration will take the public safety seriously and not bow to desires of large companies who have no concern for the safety of their products. Bush administration appointees said the FDA. did not need mandatory recall authority because companies always withdrew unsafe products when asked.
Matrixx issued a statement saying it believes there is no causal link between its products and anosmia.
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 law requires producers of approved drugs to forward to the FDA all reports of product-related injuries.
In 2006, Matrixx paid $12 million to settle 340 lawsuits from Zicam users who claimed that the product destroyed their sense of smell. Hundreds more such suits have since been filed.