- Company Characterizes FDA Action as Unwarranted, Withdraws Two US Cold
Remedy Nasal Products Citing Commitment to Consumer Safety -
SCOTTSDALE, AZ, June 17 /CNW/ - Zicam Canada Inc., a wholly owned
subsidiary of Matrixx Initiatives, Inc. (Nasdaq: MTXX) has confirmed that
products cited in a warning letter issued June 16, 2009, from the U.S. Food
and Drug Administration - specifically Zicam Cold Remedy Nasal Gel and Zicam
Cold Remedy Swabs - are not available for purchase in Canada. The warning
letter cited consumer reports that the use of these products could cause a
temporary or permanent loss of smell, known as anosmia.
Zicam Cold Remedy oral products and other products in the Zicam cold,
allergy and sinus lines were not included in the letter. The company has
announced it will comply with the FDA's requirements, but will seek a meeting
with the FDA to vigorously defend its scientific data, developed during more
than 10 years of experience with the products, demonstrating their safety.
Consumer safety is and has always been the company's top priority. While
Matrixx Initiatives believes that the FDA action today was unwarranted, it is
voluntarily withdrawing Zicam Cold Remedy Swabs and Zicam Cold Remedy Gel from
the market. Based on the FDA's recommendation, consumers should discard any
unused product or contact Zicam at 1-877-942-2626 or visit www.zicam.com to
request a refund.
Since Zicam Cold Remedy intranasal Cold Remedy products were first
introduced in the US market in 1999, more than 35 million retail units
representing over 1 billion doses have been sold, and the cumulative body of
scientific and medical evidence compiled over those years has demonstrated
both the safety and efficacy of Zicam intranasal cold remedy products under
conditions of ordinary use. Zicam Cold Remedy products have alleviated
countless numbers of colds for millions of satisfied consumers.
"Matrixx Initiatives stands behind the science of its products and its
belief that there is no causal link between its Zicam Cold Remedy intranasal
gel products and anosmia," said William J. Hemelt, Matrixx Initiatives' acting
president. "It is well understood in the medical and scientific communities
that the most common cause of anosmia is the common cold, which Zicam Cold
Remedy intranasal gel products, which are only available in the United States,
are taken to treat. Given the enormous number of doses sold and colds treated
in the United States, there is no reason to believe the number of complaints
of anosmia received is more than the number that would be expected in the
general population. There is no reliable scientific evidence that Zicam Cold
Remedy intranasal gel products cause anosmia."
Commenting on the FDA action, Hemelt continued, "We were surprised that
the FDA decided to take this action without notifying us first, given our
cooperative relationship with the FDA since we launched our first product in
1999. Had we had the opportunity to sit down with the FDA beforehand, we are
confident that the FDA would have agreed that the scientific data clearly
demonstrated the safety of our products."
Matrixx Initiatives, Inc. is engaged in the development and marketing of
over-the-counter healthcare products that utilize innovative drug delivery
systems. Zicam, LLC, its wholly owned subsidiary, markets and sells Zicam(R)
products in the cough and cold category. For more information regarding
Matrixx products, go towww.zicam.com. To find out more about Matrixx
Initiatives, Inc. (NASDAQ: MTXX), visit our Web site at www.matrixxinc.com.
For further information:
For further information: Dagmara Grabowski, Weber Shandwick, E:
email@example.com, T: (416) 642-7904, C: (647) 244-2689