Was Loss of Smell from Zicam Nasal Products Really a "Big Surprise"?

David Mittleman — Sat, 20 Jun 2009 11:55:32 GMT

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.

Originally posted at InjuryBoard by David Mittleman

Zicam medicines linked to losing your sense of smell

David Mittleman — Tue, 16 Jun 2009 18:27:52 GMT

The FDA recently sniffed out three products that cause consumers to lose their sense of smell: Zicam Cold Remedy nasal gel, Zicam Cold Remedy Nasal Swabs, and Zicam Cold Remedy Nasal Swabs, kid-size, were all found to contain zinc, an ingredient scientists say damages nerves in the nose that are needed to smell. So far, the FDA has reported that about 130 consumers have reported a loss of smell from their use of the products.

The FDA issued a warning letter to Matrixx, the company that manufacturers Zicam, to stop distribution of the products, but the FDA has yet to issue a formal recall. Instead, Matrixx will have to submit safety and effectiveness data on the drug. Following the submission of that data, Matrixx will be required to seek FDA approval if it wishes to continue marketing its Zicam products. Prior to these safety issues, Zicam has never been required to have FDA approval because the products are considered homeopathic, meaning the formulation potentially contains herbs, minerals and flowers.

Matrixx has settled hundreds of Zicam lawsuits in the past, but they maintain in a statement on their website that no plaintiff has ever won a court case because they claim that there is no proven link between the use of Zicam and the loss of smell. They recently stated that they will consider withdrawing the Zicam products from the market. All of the consumer complaints the FDA has received have come from physicians and patients, and not the manufacturer.

Originally posted at InjuryBoard by David Mittleman

Michigan Personal Injury Blog - Zicam

Was Loss of Smell from Zicam Nasal Products Really a "Big Surprise"?

Zicam medicines linked to losing your sense of smell