FDA calls for immediate stop to use of Zicam Cold Remedy and associated products

One of the most touted virtues of alternative remedies is the supposed freedom from any associated side effects. But a New Carolina resident recently found to his horror that the squirt of a homeopathic cold gel he had been innocently using led to loss of his sense of smell.

And David Richardson of Greensboro, NC is not alone, hundreds of patients have lodged complaints about Zicam Cold Remedy, saying that it destroyed their sense of smell.

Not being able to smell is not only missing out on the smell of fresh-cut grass or bread in the oven, but there is a more serious side to it as the US Food and Drug Administration points out when it says that people who can't smell may also miss danger signs in their daily lives like smoke or gas. The FDA in a swift move forced three Zicam products off the market on Tuesday and told consumers not to take them any more.

Zicam belongs to a less-than-fully regulated sector of the drug industry called homeopathic remedies which hold a unique legal status – these are mainly sold without prescription as legal drugs claiming to treat specific ailments but are not routinely reviewed for safety or benefit by the FDA. The agency does not normally act unless specific safety issues arise after marketing.

According to most scientists homeopathic remedies contain only very low levels of active ingredients in extremely low concentrations – often one part per million or less that makes them usually safe.

But according to the FDA consumers purchasing homeopathic products should be aware that these have not be reviewed by the FDA.

According to Matrixx Initiatives of Scottsdale, Arizona, Zicam was safe and the side effects were because of the colds and infections that people were treating, not on the treatment. However, the company has agreed to suspend further shipments and reimburse customers who want refunds.

The company agreed to settle about 340 Zicam claims for $12 million in 2006 and was still dealing with 17 lawsuits earlier this year. There are also some 500 more patients who may sue in the future, according to the company's filings to the US Securities and Exchange Commission.

The company said in a statement Tuesday that the safety of Zicam Cold Remedy is ''supported by the cumulative science and has been confirmed by a multidisciplinary panel of scientists.'' Matrixx said it will comply with the FDA's requirements, but will seek a meeting with the agency to ''vigorously defend its scientific data.''