FDA says to stop using Zicam

On June 17 health regulators said consumers using Zicam Cold Remedy nasal gel should stop because their sense of smell could be permanently damaged.

Zinc is an ingredient contained in the over-the-counter product. Scientists say the element zinc could damage nerves in the nose that are used for smelling.

Since 1999, the FDA says around 130 people have reported a loss sense of smell after using Matrixx Initiatives’ Zicam products. There was an extra 800 similar reports that are believed to have been made directly to the company.

Dr. Charles Lee, of the FDA’s compliance division, said that “loss of the sense of smell is potentially life threatening and may be permanent.”

This said, Matrixx upheld the safety of its products, but announced that they might be taken off the market.

Believe it or not, the FDA said that the Zicam Cold Remedy was never officially approved since it is part of a small group of remedies that are not required to go through federal review before sending out into the market. These products are known as homeopathic products, because they contain herbs, minerals and flowers.

On June 16 a warning letter was issued to Matrixx that called for the company to stop marketing its zinc-based products, but the agency did not issue an official recall. Regulators said that Matrixx needs to submit safety and effectiveness data on the drug. If they want to keep marketing Zicam intranasal zinc products, they need to seek FDA approval, says Deborah Autor, the FDA’s drug compliance division director.

The products to avoid are Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Nasal Swabs and Zicam Cold Remedy Swabs Kid Size. The last product mentioned has been discontinued but could still be in some homes medicine cabinets.