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Buyer Beware - Zicam nasal spray causes smell loss says FDA
2009-06-16 22:40:58 (GMT) (Caymanmama.com - Health News News)
San Antonio, Texas (CaymanMama.com) –Federal health regulators at the Food and Drug Administration are cautioning consumers to stop using Zicam Cold Remedy nasal gel and all other related products due to recent findings that they may damage the sense of smell.
The Zicam products, which are sold over-the-counter, contain zinc, an ingredient health officials say may damage nerves in the nose needed for smell. The other products affected by the FDA’s announcement on Tuesday are adult and child-size Zicam Cold Remedy Nasal Swabs.
The FDA states that approximately 130 consumers have reported a loss of smell after using Matrixx Initiatives’ Zicam products.
“Loss of the sense of smell is potentially life threatening and may be permanent,” said Dr. Charles Lee, of FDA’s compliance division. “People without the sense of smell may not be able to detect dangerous life situations, such as gas leaks or something burning in the house.”
Matrixx defended its products and the safety of their use, but admitted the company may remove the products from market shelves.
According to the AP, “The FDA said Zicam Cold Remedy was never formally approved because it is part of a small group of remedies that are not required to undergo federal review before launching. Known as homeopathic products, the formulations often contain herbs, minerals and flowers.”
The FDA sent a warning letter to Matrixx on Tuesday requesting the company cease marketing on its zinc-based products. However, the FDA stopped short of issuing a formal recall. Instead, federal health officials said Matrixx must submit safety and effectiveness data on the drug.
“The next step, if they wish to continue marketing Zicam intranasal zinc products, is for them to come in and seek FDA approval,” said Deborah Autor, director of FDA’s drug compliance division.
The FDA will now require formal approval due to the product’s safety issues, she added.
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