Certain Cold Remedies Linked To Loss Of Sense Of Smell Warns FDA

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Main Category: Flu / Cold / SARS
Also Included In: Complementary Medicine / Alternative Medicine;  Regulatory Affairs / Drug Approvals
Article Date: 17 Jun 2009 - 2:00 PDT

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The US Food and Drug Administration (FDA) advised consumers yesterday not to use certain cold remedies under the Zicam label because they have received over 100 reports linking the products to loss of sense of smell (anosmia) which can be long-lasting or permanent.

The products in question are marketed as three over the counter remedies:

• Zicam Cold Remedy Nasal Gel,
• Zicam Cold Remedy Nasal Swabs, and
• Zicam Cold Remedy Swabs, Kids Size (now discontinued).

The FDA said they had received over 130 reports of loss of sense of smell linked to the use of these products. The reports go back to 1999, when Matrixx Initiatives, based in Scottsdale, Arizona, first started marketing the intranasal zinc products.

Many of the people affected said they lost their sense of smell with the first dose, others said it was after several doses.

Director of the FDA's Center for Drug Evaluation and Research (CDER), Dr Janet Woodcock said:

"Loss of sense of smell is a serious risk for people who use these products for relief from cold symptoms."

"We are concerned that consumers may unknowingly use a product that could cause serious harm, and therefore we are advising them not to use these products for any reason."

According to the New York Times, this move signals a new approach by the FDA under the new Obama administration to be more aggressive than the previous president in enforcing action against drug companies.

The paper also reported that in 2006, Matrixx paid out 12 million dollars to settle over 300 lawsuits from consumers who had used Zicam and claimed that it had ruined their sense of smell. There are reported to be hundreds more lawsuits waiting.

Matrixx have refused to recall the product, which is very unusual for a drug company, although it has suspended further shipments and said in a statement they would reimburse customers seeking a refund.

The FDA has no official power to order companies to recall products, it can only ask them to do so, and in the vast majority of cases they do.

In a news release the company refused to acknowledge a "causal link" between its products and loss of sense of smell and called the FDA action "unwarranted". Representatives of the company are hoping to meet with FDA officials to review the product safety data, said the statement.

Because Zicam products are classed as homeopathic they didn't have to have FDA approval before being sold over the counter.

However, the federal agency said yesterday that they have written a warning letter to Matrixx, telling them that "these products cannot be marketed without FDA approval".

Director of the Office of Compliance at the FDA's CDER, Deborah M Autor, told the press that Matrixx had received more than 800 reports from Zicam consumers who said they had lost their sense of smell, but the company did not forward them to the FDA, reported the New York Times.

Zinc can be toxic to nerve receptors in the nose, Dr Charles E Lee, a compliance officer with the CDER, told the paper.

Autor said losing one's sense of smell was "disabling" in several ways:

"People without the sense of smell may not be able to detect dangers such as gas leaks or smoke. They could lose much of the pleasure of eating, adversely impacting the quality of life," she explained.

The FDA asked that anyone who has lost their sense of smell or experienced any other problems from using one of the affected Zicam products should see their doctor. Consumers and health professionals should report any adverse events to the FDA MedWatch Adverse Event Reporting system, they said.

-- FDA

Sources: FDA, New York Times.

Written by: Catharine Paddock, PhD
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today

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