Matrixx Says FDA Won't Budge on Recalled Zicam Products
Posted by: euser
October 28, 2009

It looks like federal health regulators aren't backing down when it comes to recalled Zicam Nasal Cold Remedies. According to a Reuters report, Matrixx Initiatives Inc., the maker of Zicam products, said the Food & Drug Administration (FDA) is "unwilling to reverse its position regarding the warning letter" it issued over Zicam nasal remedies earlier this year.

In June, the FDA said it had received 130 reports of anosmia-loss of sense of smell-in people who had used the product. Following the FDA alert, Matrixx Initiatives recalled two of the products: Zicam Cold Remedy Nasal Gel and Zicam Cold Remedy Swabs. The company had already withdrawn Zicam Cold Remedy Swabs, Kids Size, the third product named by the FDA.

At the same time, the FDA issued a warning letter to Matrixx. In the letter, the FDA said Matrixx had failed to inform it of 800 anosmia reports linked to the recalled cold remedies. Matrixx has admitted that it did not pass along those reports to the FDA, but has maintained that its legal counsel advised it was not required to forward those reports to the agency. In the Warning Letter, the FDA warned the firm that the products cannot be marketed without agency approval and also stated that the three Zicam nasal remedies did not include adequate warnings about the risk of loss of sense of smell.

According to Reuters, Matrixx said in a regulatory filing with the Securities and Exchange Commission (SEC) that the FDA will not reverse its stance that the recalled Zicam products could not be marketed without agency approval. The filing said the company is currently evaluating its options. Matrixx also said it was reviewing the FDA's contention that it should have filed adverse event reports on several individual Zicam loss of smell cases, and that it would be responding soon.

Since the Zicam nasal cold remedy recall, Matrixx has been hit with several class action lawsuits filed on behalf of people who claim the products caused them to suffer anosmia. Earlier this month, the U.S. Judicial Panel on Multidistrict Litigation consolidated the Zicam litigation for pretrial proceedings in the District of Arizona for coordinated handling.

According to Reuters, the recent SEC filing also disclosed that two shareholder derivative lawsuits were filed in September against current and former Matrixx officers related to the recall.

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U.S. Drug Watchdog Issues Zicam Warning
Posted by: euser
October 21, 2009

The US Drug Watchdog Calls Zicam Nasal Gel or Zicam Swabs a Looming Disaster that May Cause Loss of Taste or Smell

The US Drug Watchdog is doing everything possible to get the word out to all US citizens about recalled Zicam products. So what exactly did the FDA say about zicam Nasal Gel & zicam Cold Remedy Swabs in its recall? The U.S. Food and Drug Administration (FDA) has warned Matrixx Initiatives to stop selling three over-the-counter zicam products, marketed as cold remedies, after more than 130 people reported developing long-lasting or permanent loss of smell (called anosmia). The warning applies to: zicam Cold Remedy Nasal Gel, zicam Cold Remedy Nasal Swabs, and zicam Cold Remedy Swabs, Kids Size (a discontinued product).If a consumer has lost their sense of taste or smell after using a recalled Zicam product, please call the US Drug Watchdog at 866-714-6466, or contact the group via its web site at http://usdrugwatchdog.com/

(PRWEB) October 21, 2009 -- The US Drug Watchdog is urging all US Consumers to check to see if they have recalled Zicam products in their medicine cabinets. If they do, and there has been no loss of taste, or smell, throw the product away. If on the other hand a US consumer has lost their sense of taste or smell within the last three years, after using the recalled zicam products, please call the US Drug Watchdog immediately at 866-714-6466, or contact the group via its web site at http://usdrugwatchdog.com/

our worst case scenario is a consumer gets a cold, or the flu, goes to their medicine cabinet & uses a recalled Zicam product. The consumer uses a recalled product & then they lose their sense of taste or smell, because the Zicam recall notification was only on the news for one day (June 16th 2009).

there could be millions of US households that have recalled Zicam Cold Remedy Nasal Gel, or Zicam Cold remedy swabs in their medicine chests, that need to be thrown away. However, if you have lost your sense of taste or smell, do not throw the recalled product away-its evidence you will need.

our greatest fear is that with the cold & flu season already here, completely innocent consumers will use one of the recalled Zicam products and lose their sense of taste, or smell forever.

Please share this press release with everyone you know. Make sure these recalled Zicam products are not in your medicine cabinets at home.

we know of a young woman, who had a great job in the food & wine industry. She has lost her sense of taste & smell. She is now unemployed.

Why Should Every American Check Their Medicine Cabinets For Recalled Zicam Products?

According to the US Drug Watchdog, "our worst case scenario is a consumer gets a cold, or the flu, goes to their medicine cabinet & uses a recalled Zicam product. The consumer uses a recalled product & then they lose their sense of taste or smell, because the Zicam recall notification was only on the news for one day (June 16th 2009)." If a consumer lost their sense of taste or smell after using a recalled Zicam product, please call the US Drug Watchdog immediately at 866-714-6466, or contact the group via its web site at http://usdrugwatchdog.com/

How Many Americans Could Be Affected With The Recalled Zicam Products?

According to the US Drug Watchdog,"there could be millions of US households that have recalled Zicam Cold Remedy Nasal Gel, or Zicam Cold remedy swabs in their medicine chests, that need to be thrown away. However, if you have lost your sense of taste or smell, do not throw the recalled product away-its evidence you will need." For more information please contact the US Drug Watchdog at 866-7144-6466, or contact the group via its web site at http://usdrugwatchdog.com/

National Appeal: The US Drug Watchdog is asking every US citizen to share this press release with everyone they know. According to the group,"our greatest fear is that with the cold & flu season already here, completely innocent consumers will use one of the recalled Zicam products and lose their sense of taste, or smell forever." For more information please contact the US Drug Watchdog at 866-714-6466, or contact the group via its web site at http://usdrugwatchdog.com/

A Special Note From The US Drug Watchdog To All US Women & Mothers. "Please share this press release with everyone you know. Make sure these recalled Zicam products are not in your medicine cabinets at home." The group is saying, "we know of a young woman, who had a great job in the food & wine industry. She has lost her sense of taste & smell. She is now unemployed."

What products are affected by this warning?

FDA's action affects Zicam's three intranasal products that contain zinc. The three Zicam products claim to reduce the duration of the common cold and the severity of cold symptoms.

The products (listed with their size and product numbers) are

Zicam Cold Remedy Nasal Gel (15mL, NDC 62750-003-10) Zicam Cold Remedy Swabs (20 swabs, NDC 67250-003-20) Zicam Cold Remedy Swabs, Kids Size (20 swabs, NDC 67250-003-21)

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