June 17, 2009

Sense of Smell Permanently Damaged By Zicam

Federal health regulators made a crucial announcement Tuesday suggesting that consumers cease use of Zicam Cold Remedy nasal gel and similar products due to evidence proving cause of irreversible damage to smell sensory, the Associated Press reported.

Zinc has been found to be the unsafe element in the over-the-counter products.  Adult and children-size Zicam Cold Remedy Nasal Swabs were also listed as culpable products linked to smell sensory damage in the Food and Drug Administration's notice. 

Since 1999, the FDA has recorded 130 accounts of consumer loss of smell after ingesting Zicam products.

"Loss of the sense of smell is potentially life threatening and may be permanent," said Dr. Charles Lee. "People without the sense of smell may not be able to detect life dangerous situations, such as gas leaks or something burning in the house."

Because Zicam Cold Remedy is classified as a homeopathic product, meaning the formulations typically consist of herbs, minerals and flowers, the FDA never officially endorsed it.  Such products are not required under federal law to receive approval before being marketed to consumers.  
Although a warning letter was delivered to manufacturer Matrixx Initiatives on Tuesday requesting the company cease marketing of its zinc-based products, the agency has not yet issued a formal recall.  Rather, regulators are demanding safety and effectiveness data on the drug be submitted. 

"The next step, if they wish to continue marketing Zicam intranasal zinc products, is for them is for them to come in and seek FDA approval," said Deborah Autor, director of FDA's drug compliance division.

Official authorization is now being required by the agency because of the safety factors brought about with the product, she added. 

Despite the threat of the many lawsuits Matrixx Initiatives is up against, its Web site noted that "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."

Stock prices for the Scottsdale, Arizona-based company dropped to a 52-week low after the release of the FDA notice.  A representative for the company could not be reached for comment Tuesday. 

Matrixx possesses more than 800 consumer complaints indicating lost smell, which health officials have requested access to review.  In 2007, a law was made effective that required manufacturers to report such effects, but FDA regulators have not said whether the company has breached the law. 

The manufacturer did not provide any of the 130 reports disclosed to the FDA.  These came solely from physicians and patients.  
The somewhat small number of complaints, regulators informed, accounted for the agency's lengthy investigation.

"FDA doesn't take action against drug products without evaluating all of the circumstances surrounding the issues with the product," Lee said.
Shares of Matrixx Initiatives Inc. drastically dropped $10.71, or 55.7 percent, to $8.53 in afternoon trading.


Image Credit: http://www.zicam.com/products


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