Smells like trouble; FDA warns against Zicam

After hundreds of lawsuits and millions paid out in settlements, the FDA says it smells trouble. Now the FDA is warning people not to use a popular over the counter medication called Zicam.

UCSD Doctor Terence Davidson says he has seen at least two dozen patients who have lost their sense of smell after using Zicam. Some lost their sense of smell after just one dose.

“They squirted it. They sniffed it. They had this incredible ten out of ten pain,” says Dr. Davidson.

The FDA says about 130 consumers have reported a loss of smell after using Matrixx Initiatives’ Zicam products since 1999. Shares of the Scottsdale, Ariz.-based company plunged to a 52-week low after the FDA announcement, losing more than half their value.

“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 the safety of its products, but said late Tuesday it will withdraw Zicam Cold Remedy Swabs and Zicam Cold Remedy Gel from the market.

Dr. Davidson says there is little evidence that the nasal spray has any medical benefit.

“Unfortunately it doesn’t make much scientific sense.”

Zicam was treated as a homeopathic medicine because it contains zinc - so it did not have to get formal FDA before being put on the shelves.

The FDA says because of the safety concerns that will change.

“This has been a horrible disaster,” says Dr. Davidson.

Matrixx has settled hundreds of lawsuits connected with Zicam in recent years, but says on its Web site: “No plaintiff has ever won a court case, because there is no known causal link between the use of Zicam Cold Remedy nasal gel and impairment of smell.”

Associated Press reporters Matthew Perrone and Jeff Donn contributed to this story.

Tags: SDNN

This entry was posted on Wednesday, June 17th, 2009 at 7:58 am and is filed under Health, Lifestyle. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.