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Zicam: Good Morning America Reported Problems at Matrixx in 2004; FDA Arrives 5 Years later

By Jim Edwards | Jul 6, 2009

ABC’s Good Morning America was ahead of the FDA in calling suspicion to Matrixx Initiatives’ Zicam, according to an inspection report. The FDA triggered a recall of Zicam in June.

Matrixx said last week that six class-action suits had been filed alleging that its Zicam cold “remedy” can disable a person’s sense of smell, plus a another suit featuring 117 plaintiffs.

And law firm Hagens Berman Sobol Shapiro said it was probing insider trading at the company (it’s jumping on the coattails of the SEC). Lawyers smell blood in the water — the company has settled 600 Zicam suits in the past.

Last week’s FDA report offers some curious clues as to how bad the situation is at Matrixx. Some excerpts:

The firm does not classify and report anosmia (loss of smell) or loss of taste as a serious adverse event and therefore does not report these complaints to the Food and Drug Administration …

… some degree of anosmia, of either short or long-duration, is complained of by about 3.6 persons for every 100,000 units sold

The peak rate was about 6.7 per 100,000 during 2004, which management said was caused primarily by a negative television show during early 2004.

That TV show was Good Morning America, the report said.

Due to illness, the firm’s President and CEO, Carl J. Johnson, was not available for most of the inspection…

Perhaps he was treating a cold with his own product.

Hat tip to IguanaBio.

Jim Edwards, a former managing editor of Adweek, has covered drug marketing at Brandweek for four years, and is a former Knight-Bagehot fellow at Columbia University's business and journalism schools. Follow him on Twitter or send him an email.

BNET User Analysis

Web Buzz:
  • Matrixx Initiatives: A Critical Test of Crisis Management

    Seeking Alpha - 141 days 15 hours 31 minutes ago

    We have seen a decimation in the shares of Matrixx Intiatives MTXX as a result of the FDA’s June 16th warning letter indicating anosmia experienced in a group of several hundred Zicam nasal product users. Initially Matrixx went into defensive mode, but has since “voluntarily” recalled the Zicam nasal

  • Matrixx withheld 800 complaints on Zicam

    Fierce Pharma - 158 days 13 hours 33 minutes ago

    Matrixx Initiatives may profess its surprise at the FDA's warning against its Zicam cold-care products, but the company admits it held onto 800 consumer complaints about side effects linked to the now-withdrawn nasal spray and swabs. The FDA didn't hear about those reports, in fact, until inspectors ran across them during a routine check in...

  • FDA Issues Warning Over Matrixx Intiatives’ Zicam

    PharmTech - 161 days 7 hours 27 minutes ago

    The US Food and Drug Administration today warned consumers to stop taking three over-the-counter versions of Zicam, made by Matrixx Initiatives (Scottsdale, AZ). The company has received a Warning Letter, but a product recall has not been issued.   The warnings cover the following products: Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Nasal...

  • FDA warning on Zicam tanks Matrixx stock

    Fierce Pharma - 160 days 16 hours 41 minutes ago

    Matrixx Initiatives suffered a 68 percent drop in share price Tuesday after federal regulators warned consumers to stop using its Zicam Cold Remedy products. In a release, the FDA said the OTC products could cause "long-lasting or permanent" loss of smell. Report More information about formatting options

  • Matrixx Claims Victim Status in Zicam Ban; Company Sat on 800 Complaints

    BNET Pharma - 152 days 13 hours 43 minutes ago

    Matrixx Initiatives claims the FDA’s ban of Zicam cold remedy nasal swabs is political and the company is the victim — not the 130 people who lost their sense of smell. Meanwhile, the SEC has joined the FDA in investigating the company, according to the WSJ, following news that the company had been sitting on 800 consumer complaints about...

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  •  
    1

    HBSS

    07/22/09 | Report as spam

    Makers of Zicam (MTXX) under investigation

    Do you own Matrixx stock (Nasdaq - MTXX)?

    I work with a law firm investigating reports of possible securities law violations by Matrixx Initiatives, Inc., the maker of Zicam.

    In a letter to Matrixx, the FDA concluded certain Zicam products may pose serious risks to consumers.

    When the letter was released, Matrixx stock plummeted from approximately $19 per share to less than $7 per share. Since December 2007, insiders have sold more than $2.7 million worth of Matrixx shares.

    Learn more: www.hbsslaw.com/matrixx

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