Was Loss of Smell from Zicam Nasal Products Really a "Big Surprise"?
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David Mittleman Attorney
(877) 245-6841 Ext 430
June 20, 2009 11:55 AM
Matrixx, the manufacturer of Zicam cold medicines, stated that it was a “complete surprise” when they received a warning letter from the FDA last Tuesday, telling them to stop selling their intranasal products because of the harmful effects they had on consumers’ sense of smell. However, new information has arisen that the company already knew that their products were dangerous. In fact, in a routine investigation of Matrixx back in May, the FDA discovered that the company had received 800 consumer complaints that users were losing their sense of smell from using nasal gel and nasal swab products, which the company did not report to the FDA.
In a conference call on Thursday, the acting president and chief operating officer of Matrixx, said he was advised by his legal council that he was not required to turn over the 800 complaints because they did not fit with a 2007 FDA regulation requiring companies to turn over reports of serious side effects from non-prescription, homeopathic medicines. He also added that the recall of the products will cost the company $10 million and will ultimately “shrink the company”.
Matrixx must seek FDA approval if they want to continue marketing their nasal products. However, Matrixx acting president and chief operating officer said that would take too long and would be “highly expensive”. Instead, the company is currently seeking a meeting with the FDA, to attempt to get them to reverse their decision using several of their own studies that allegedly show that the nasal medicines did not result in loss of smell. |
