Drug Safety Developments

Matrixx says FDA unwilling to change stance on Zicam

Quoted from http://www.reuters.com/article/governmentFilingsNews/idUSBNG7944120091026

Matrixx says FDA unwilling to change stance on Zicam

Oct 26 (Reuters) - Matrixx Initiatives Inc said the U.S. health regulator has indicated that it is unwilling to reverse its position regarding the warning letter issued on company's nasal versions of Zicam cold remedy.

In June, the company voluntarily withdrew two of its existing Zicam products after the U.S. Food and Drug Administration issued a warning letter that the products could cause a loss of smell. [ID:nN24151638]

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Zicam nasal products recall starts

Quoted from http://www.reuters.com/article/healthNews/idUSTRE55N2NE20090624

Zicam nasal products recall starts

Wed Jun 24, 2009 8:49am EDT

NEW YORK (Reuters) - Matrixx Initiatives has started to notify U.S. customers of its recall of nasal versions of its Zicam cold remedy, a week after U.S. regulators told the company to stop selling the products.

Matrixx said on Wednesday that it was in the process of formally notifying retailers, wholesalers and distributors of its recall of all Zicam Cold Remedy Nasal Gel and Zicam Cold Remedy Gel Swabs, even as the company maintained it "vigorously disagrees" with the U.S. Food and Drug Administration over allegations that the products are not safe and were unlawfully marketed.

The company "is conducting this recall because of its desire to cooperate with the FDA," Matrixx said.

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Scottsdale-based maker of Zicam faces lawsuit

Quoted from http://www.azcentral.com/news/articles/2009/06/22/20090622biz-zicam0623-CP.html

Scottsdale-based maker of Zicam faces lawsuit

by Ken Alltucker - Jun. 22, 2009 04:54 PM

The Arizona Republic

In what could be the opening salvo in a new wave of lawsuits against the Scottsdale-based maker of Zicam, lawyers on Monday filed a lawsuit on behalf of 117 people who claim they have suffered loss of smell after using the popular nasal spray.

Among those suing Scottsdale-based Matrixx Initiatives Inc. include one dozen Phoenix-area residents as well as the chef of an upscale Las Vegas-area restaurant who no longer can smell or taste food.

Matrixx officials said Monday they had not seen the lawsuit filed in Maricopa County Superior Court, but a spokesman said the company believes that its nasal products are safe and do not cause loss of smell.

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FDA warning stuns Scottsdale company Matrixx

Quoted from http://www.azcentral.com/arizonarepublic/business/articles/2009/06/19/20090619biz-zicam0619.html

FDA warning stuns Scottsdale company Matrixx

Report said Zicam swabs, gels can cause loss of smell

by Ken Alltucker - Jun. 19, 2009 12:00 AM

The Arizona Republic

The Scottsdale company that makes and sells Zicam said the Food and Drug Administration's safety warning about the popular nasal gels and swabs came as a complete surprise as the firm mounts an aggressive defense of its products' safety.

Matrixx Initiatives Inc. executives said they want to meet with the FDA to dispute the federal agency's warning issued this week that the Zicam gel and swabs can permanently damage the sense of smell.

"We are hopeful that if we can tell our story to the FDA, we can get them to change their mind," William Hemelt, acting president and chief operating officer of Matrixx, said during a Thursday morning conference call with analysts. "We are certainly hoping for that outcome, but we are moving ahead as if that may not happen."

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Matrixx Said It Didn’t Give 800 Zicam Reports FDA

Quoted from http://www.bloomberg.com/apps/news?pid=newsarchive&sid=aDC21YXDGWvY

Matrixx Said It Didn’t Give 800 Zicam Reports to FDA

By Shannon Pettypiece

June 18 (Bloomberg) -- Matrixx Initiatives Inc. said today it didn’t turn over to U.S. regulators 800 consumer complaints about side effects linked to its withdrawn Zicam nasal spray and swabs.

 

Matrixx, based in Scottsdale, Arizona, stopped selling the cold remedies on June 16 after the Food and Drug Administration warned consumers the treatments may cause a loss of smell. Matrixx today defended its products and called the FDA warning “a surprise,” during a conference call with analysts. ...

 

“We have complaints but we weren’t required to send them,” Hemelt said. “At least we didn’t believe we were required to send them and we based that on an opinion of counsel who looked at the FDA regulation and said no, it doesn’t fit.”

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Homeopathy and potential hazards

Quoted from http://www.denverpost.com/business/ci_12615248

Homeopathy and potential hazards

Zicam suits spur re-examination

By Jeff Donn

The Associated Press   Posted:06/18/2009

CAMBRIDGE, Mass. — The unsettling little secret of Zicam Cold Remedy finally spilled out this week. Though widely sold for years as a drug for colds, it was never tested by federal regulators for safety like other drugs. And that was perfectly legal — until scores of consumers lost their sense of smell.

One little word on Zicam's label explains all this: "homeopathic." Zicam and hundreds of other homeopathic remedies — highly diluted drugs made from natural ingredients — are legally sold as treatments with explicit claims of medical benefit. Yet they don't require federal checks for safety, effectiveness or even the right ingredients.

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FDA: over-the-counter cold spray Zicam has caused loss of smell in more than 100 patients

Quoted from http://www.startribune.com/lifestyle/health/48157892.html?elr=KArksLckD8EQDUoaEyqyP4O:DW3ckUiD3aPc:_Yyc:aULPQL7PQLanchO7DiUsX

FDA: over-the-counter cold spray Zicam has caused loss of smell in more than 100 patients

The Food and Drug Administration says consumers should stop using Zicam Cold Remedy nasal gel and related products immediately.

By MATTHEW PERRONE, Associated Press

Last update: June 16, 2009 - 2:28 PM

WASHINGTON - Consumers should stop using Zicam Cold Remedy nasal gel and related products because they can permanently damage the sense of smell, federal health regulators said Tuesday.

The over-the-counter products contain zinc, an ingredient scientists say may damage nerves in the nose needed for smell. The other products affected by the Food and Drug Administration's announcement are adult and kid-size Zicam Cold Remedy Nasal Swabs.

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.

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