Matrixx Confirms Zicam Side Effect Reports Weren't Sent to FDAJun 19, 2009 | Parker Waichman LLP
The Food & Drug Administration (FDA) said this week that it had received 130 reports of Zicam users who lost their sense of smell after using nasal varieties of the product. But those reports may only scratch the surface of the Zicam problems. According to Bloomberg.com, Matrixx Initiatives has confirmed that it received an additional 800 similar Zicam reports which were not turned over to the FDA.
The 800 additional reports were discovered by the FDA during a routine inspection in May, Bloomberg.com said. An FDA official said in a June 16 telephone interview that Matrixx was required to turn over reports of side effects to the FDA according to a 2007 regulation.
During a conference call with the media yesterday, Matrixx acting president and chief operating officer William Hemelt admitted the company had received the 800 Zicam complaints. According to Bloomberg.com, Hemelt said the reports weren't forwarded to the FDA because of "an opinion of counsel who looked at the FDA regulation and said no, it doesn’t fit.”
Zicam products are popular over-the-counter nasal cold remedies. Zinc gluconate, the active ingredient in Zicam products, has long been believed to produce a caustic action on the nasal passages that, over time, can lead to a loss of smell. Because they are considered homeopathic remedies, Zicam products did not require FDA approval. However, the agency can intervene when there’s evidence a homeopathic drug may pose a risk to consumers.
Earlier this week, the FDA warned consumers not to use three Zicam products - - Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Swabs and Zicam Cold Remedy Swabs, Kids Size. The FDA said that many people who experienced a loss of sense of smell say that the condition occurred with the first dose of Zicam, although some people have reported loss of sense of smell after later doses. The FDA was concerned that the loss of sense of smell may be permanent.
In addition, the FDA sent a warning letter to Matrixx Initiatives advising the firm that these products cannot be marketed without agency approval. The warning letter also states that the products do not include adequate warnings about the risk of loss of sense of smell.
Following the FDA warning, Matrixx recalled Zicam Cold Remedy Gel and Zicam Cold Remedy Swabs. Zicam Cold Remedy Swabs, Kids Size had already been taken off the market.
Zicam is Matrixx Initatives' best selling product line, and accounts for 40% of the company's sales. Matrixx has said that its Zicam recall will cost it around $10 million.