Matrixx Maker of Zicam Warned by FDA

In a letter from the FDA on Tuesday, June 16, 2009, Matrixx Initiatives, Inc. was ordered to file a New Drug Application with the FDA for its Zicam Cold Remedy products. The warning letter was prompted by more than 130 Adverse Event Reports to the FDA. The FDAs warning letter to Matrixx also indicates that the FDA is aware of over 800 reports of loss of smell or Anosmia made directly to Matrixx.

Those numbers are frightening considering that only a very small number of adverse events are usually reported to drug manufacturers and the FDA. Given that close to 1,000 people have already reported loss of smell, there are probably thousands, if not tens of thousands of people, who have suffered some loss of smell due to Zicam products.

According to the New York Times, Dr. Margaret Hamburg, FDA commissioner, said the incidence of anosmia associated with Zicam 'strikes us as a fairly large problem.' The company "paid $12 million to settle 340 lawsuits from Zicam users who claimed that the product destroyed their sense of smell" in 2006, and "hundreds more such suits have since been filed."

In conjunction with the warning letter to Matrixx, the FDA warned consumers to stop using Zicam products immediately. You may report adverse reactions or quality problems experienced with the use of this product to the FDA's MedWatch Adverse Event Reporting Program by phone at 1-800-FDA-1088 or online at http://www.fda.gov/Safety/MedWatch/default.htm