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Zicam, Homeopathic Remedies, and You: How to Protect Yourself

Submitted by Anonymous on Jun 16th, 2009

Another legal battle is quickly heating up.

The FDA announced this morning a product recall of Zicam nasal spray due to the amount of zinc in the drug. Zinc has been shown to damage olfactory nerves and continued use of the product may lead to loss of smell and other nerve damage. (We're foodies here in the office - losing a sense of smell results in losing a sense of taste and none of us in the office are willing to sacrifice taste for a possible cold remedy.)

Yet Zicam is marketed as a homeopathic cold remedy - which are not reviewed by the FDA.

So if the FDA doesn't review a drug, how can the government force Zicam into a drug recall?

Simply by sending a warning letter, remarking on the safety and efficacy of the remedy. The company which manufactures and sells Zicam, Matrixx Initiatives, received a letter from the FDA this morning. This letter, as it is a government document, was simultaneously released to the press. Just a case of bad business?

Hardly. This has everything to do with patient safety.

In 2006, Matrixx settled more than 340 lawsuits pending against Zicam for harms afflicted on consumers for upwards of $12 million. Since this time, another 130 complaints have been filed with the FDA. And as the warning letter makes completely clear: ?many homeopathic drug products are manufactured and distributed without FDA approval.? And the FDA can intervene when there's evidence a homeopathic drug poses a risk to consumers.

This power keeps the snake-oil salesman off our doorstep; this power also removes dangerous, unsafe, and defective drug combinations from our cabinets.

Because of the possible risks to consumers, the FDA will enforce its standard new-drug approval requirements for intranasal Zicam products - Matrixx will have to demonstrate that ?based on adequate and well-controlled clinical investigations ? [the] product is safe and effective for each of its intended uses.?

Maybe homeopathy will win in the face of science. But kudos to the FDA for taking a close, scrutinizing look at a potentially dangerous drug - before more people are irreparably injured by their normal use of Zicam.