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drug_recall zicamZicam is a homeopathic over the counter medication that that is supposed to reduce the duration of the common cold, even if started as late as the second day after the cold begins. Manufactured by Matrixx Initiatives, Inc., Zicam Cold Remedy comes in different forms. One of the most popular forms is the Zicam No-Drip Liquid Nasal Gel Cold Remedy, which has received consumer support since it has become available. Reports are being made indicating Zicam may be linked to serious effects, and Zicam lawsuits have been filed in response.
According to Zicam labeling, the product is clinically proven to reduce the duration of the common cold and the severity of cold symptoms. The lawsuits that have been filed claim the use of Zicam has caused anosmia to occur. Anosmia is the total loss of smell and consumers have claimed after using Zicam Anosmia, or sometimes hyposmia, or partial loss of smell was suffered.
The Zicam suits allege it has been a long known fact that direct application of intranasal zinc has been the cause of the anosmia and hyposmia. Intranasal zinc solutions were used in 1936-1937 to prevent polio but it was found to be unsuccessful and to cause a loss of smell in some instances. The FDA does not test for safety or efficacy on cold remedies like Zicam that contain soluble zinc.
Developing, manufacturing, and marketing over the counter drugs, Matrixx Initiatives, Inc. is involved with Zicam, LLC. Zicam, LLC is a wholly owned subsidiary and it produces, as well as markets and sells Zicam Cold Remedy. In addition to Zicam Cold Remedy, the company has an entire Zicam line that has been successful, with revenue in the third quarter ending September 30, 2003 increasing 163% to $13.4 million from $5.1 million in the comparable year ago period.
After the Dow Jones reported the FDA is investigating consumer complaints regarding the use of Zicam and anosmia, Matrixx responded by saying the manufacturer was not aware of an FDA inquiry into Zicam’s safety. According to the company, all Zicam products are manufactured and marketed adhering to FDA guidelines on homeopathic medicine. The company’s reassurances may not be enough however, as Zicam lawsuits have been filed against both Matrixx Initiatives and Zicam LLC.
Anosmia is the total loss or impairment of the sense of smell. Zicam cold remedy, and other new cold remedies containing soluble zinc like zinc gluconate have not been FDA tested for safety or efficacy. When anosmia occurs, the damage might be temporary or permanent without reversible damage.
If Zicam Cold Remedy poses a risk for anosmia like the lawsuits allege, the popular homeopathic product may lose popularity and be the target of much more litigation in the future.
The manufacturer of the popular over-the-counter cold remedy Zicam will pay $12 million to settle 340 lawsuits filed against the company by consumers who allege the nasal gel impaired their ability to smell or taste only after one use.
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The Quigley Corp. has become the latest target of allegations claiming its Cold-Eeze nasal spray has resulted in anosmia, the lost sense of smell. Similar lawsuits over the past year have also been filed against Matrixx Initiatives Inc., the make...
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