A $12 million settlement, with some 300 class-action plaintiffs, involving Zicam and its manufacturer, Matrix Corp., has not stopped people from coming forward with additional personal injury claims alleging the over-the-counter (OTC) nasal spray has caused them to lose their sense of smell and/or taste.
In order to understand the historical context in which a product like Zicam was introduced, you would have to go back to the late 1930s when intranasal zinc sulfate solutions were used to prevent polio. Those products, however, were removed from the market because they proved unsuccessful and due to the fact that some users suffered a loss of smell.
Since that time, a number of medical researchers have claimed that products containing zinc are neurotoxic and therefore linked to possible nerve damage.
Neurotoxins act specifically on nerve cells (neurons) usually by interacting with membrane proteins and ion channels.
Environmental neurotoxins are known as exogenous and include gases (carbon monoxide), metals (mercury, lead, zinc), liquids (ethanol) and a multitude of solids. When exogenous toxins are taken in, the effect on neurons is largely dependent on dosage and duration.
Of course, since the senses of smell and taste (like the other senses) rely on a sophisticated network of neurological processes, any neurotoxin has the potential to interfere with or even damage or destroy them.
It is because of these facts that there a serious controversy over the safety of OTC zinc-based, homeopathic medications like Zicam that claim to shorten the duration of the common cold.
The maker, marketer, and seller of Zicam (R) Cold remedy nasal gel, Zicam, LLC (a wholly owned subsidiary of Matrixx Initiatives, Inc. Ã¢â‚¬â€œ an OTC drug developer, manufacturer, and marketer) has steadfastly defended its product as being safe.
Only last year, in a press release, Matrixx claimed that any reports alleging anosmia (loss of smell) associated with Zicam(R) Cold Remedy zinc products Ã¢â‚¬Å“are completely unfounded and misleading.Ã¢â‚¬Â
Matrixx asserted that any research linking nasal products containing zinc to the onset of anosmia were erroneous because the compound found in the 1930s products was concentrated zinc sulfate as opposed to the zinc gluconate found in Zicam. Zinc sulfate Ã¢â‚¬Å“is a mineral salt that reacts with water to produce a strong acid (sulfuric acid) and zinc oxide,Ã¢â‚¬Â while Ã¢â‚¬Å“zinc gluconate is a weak organic salt that dissolves to form positively charged zinc ions and negatively charged gluconate Ã¢â‚¬â€œ a naturally occurring, non-toxic compound found in all human tissue.Ã¢â‚¬Â
The FDA does not test cold remedies containing soluble zinc for safety or efficacy and, thus, it was not until late 2004 that the agency only began to take notice that there might be a potentially serious risk posed by such products.
By that time, however, researchers at University of Colorado Health Sciences Center Taste and Smell Clinic had already documented the loss of smell among Zicam users for over a year. In addition, a number of lawsuits had been commenced around the U.S. alleging anosmia as an injury that could occur with as little as one application of the Zicam nasal gel.
The problem had also been presented for discussion at the September 2003 meeting of the American Rhinologic Society. Clearly, there was much more to this than the simple denial issued by Matrixx.
A lawsuit has been commenced by a major plaintiffsÃ¢â‚¬â„¢ personal injury firm against Matrixx Initiatives, Inc. Zicam, LLC, and Botanical Laboratories, Inc., on behalf of a woman who claims to have lost her senses of smell and taste after using Zicam Cold Remedy nasal gel.
The lawsuit, now pending in the U.S. District Court for the Western District of Louisiana in Shreveport, Louisiana, was brought by Parker & Waichman, a New York based firm that represents clients throughout the country in pharmaceutical litigation involving several allegedly dangerous drugs.
In the Zicam action, the plaintiff alleges that in December 2003, she began using Zicam Cold Remedy nasal gel to relieve her cold symptoms.
After using the product as directed, however, she began to experience a loss of her sense of smell and her sense of taste and has never regained these senses completely.Ã‚Â She has been diagnosed as having a permanent partial loss of the senses of smell and taste.
The loss of the senses of smell and taste can have very serious consequences aside from the obvious loss of the enjoyment and pleasure associated with the exercise of those senses.
Danger areas documented by studies of people suffering from the loss of these senses include: cooking related accidents; exposure to undetected fires, smoke, or gas leaks; eating spoiled foods or toxic substances; and other situations where either of the senses is a primary method of detection of sensory information.
In addition, the loss of these senses can cause collateral damages such as to anyone engaged in a profession where smell or taste is a critical requirement (chef; taste tester; cosmetics and perfume industry; wine, beer, or spirits industry).
In addition to alleging the dangerous nature of the zinc-based gel itself, the lawsuit claims the product label, promotional materials, and advertisements used in conjunction with the sale of Zicam Cold Remedy Nasal Gel did not provide sufficient warning and instructions about the risks and adverse side affects associated with the use of the product.
Thus, while the $12 million settlement may have resolved a substantial number of early actions, it appears that claims involving Zicam will continue to be made as long as the OTC cold remedy is marketed. Although Matrixx may honestly believe that its product does not cause the loss of smell or taste, the number of cases in which those injuries are apparently documented cannot be merely a coincidence.