Yourlawyer.com (Anosmia News)

Zicam Safe, Matrixx Says, But Recall Possible

Wed, 17 Jun 2009 00:00:00 -0700

Matrixx Initiatives, the maker Zicam intranasal cold remedies, said in a press release yesterday that it may issue are recall of some of the products, even though it still asserts that they are safe. The press release was issued in response to yesterday's Food & Drug Administration (FDA) warning that use of three Zicam products - Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Swabs, and Zicam Cold Remedy Swabs, Kids Size - could lead to a loss of sense of smell.

According to a posting on its website, the FDA has received 130 reports of anosmia—the loss of sense of smell—associated with use of the three Zicam products covered by its alert. During a conference call to announce the Zicam alert, the FDA also said Matrixx had received an additional 800 reports it hasn’t made available to the agency. The FDA said that many people who experienced a loss of sense of smell say that the condition occurred with the first dose of Zicam, although some people have reported loss of sense of smell after later doses.

The agency said it was concerned that anosmia caused by the Zicam products could be permanent. It warned users not to use any of the three Zicam intranasal products named in the alert, and said anyone who experienced loss of sense of smell or other problems after using any zinc-containing products that are administered into the nose.

The FDA also said it sent a warning letter to Matrixx advising the firm that these products cannot be marketed without agency approval. The warning letter also states that the products do not include adequate warnings about the risk of loss of sense of smell.

In yesterday's press release, Matrixx - as it has done for years - continued to insist Zicam intranasal cold remedies are safe and do not cause anosmia, and called the FDA's actions "unwarranted." The company said it was working to determine a response to the FDA "which may include removing these products from the marketplace."

Zicam, which also comes in melting tablet and liquid form (these varieties were not included in the FDA alert), is Matrixx Initiatives' top-selling product line, and accounts for about 40 percent of its sales. However, there have been concerns for several years now that the nasal varieties of Zicam remedies could lead to anosmia.

Zinc gluconate, the active ingredient in Zicam products, has long been believed to produce a caustic action on the nasal passages that, over time, can lead to a loss of smell. According to Bloomberg.com, the FDA first received reports of a loss of smell linked to Zicam in 1999. In 2006, Matrixx agreed to pay $12 million to settle claims by 340 plaintiffs who said they lost their sense of smell after using the product.

Federal Lawsuit Refocuses Attention on Serious Risks Posed by Zicam Cold Remedy Nasal Gel

Wed, 21 Dec 2005 00:00:00 -0800

As far back as the late 1930s, intranasal zinc sulfate solutions were used to prevent polio. The products were removed from the market because they proved unsuccessful and due to that some users suffered a loss of smell. Since that time, a number of medical researchers have claimed there is a link between products containing zinc and 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 over-the-counter (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. 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 “are completely unfounded and misleading.”

Matrixx asserted that any research linking nasal products containing zinc to the onset o f 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 “is a mineral salt that reacts with water to produce a strong acid (sulfuric acid) and zinc oxide,” while “zinc gluconate is a weak organic salt that dissolves to form positively charged zinc ions and negatively charged gluconate, a naturally occurring, non-toxic compound found in all human tissue.”

Unfortunately, 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 serious risk posed by the 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.

Now, a major plaintiffs’ personal injury firm has announced it has filed suit 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 was filed Tuesday in the U.S. District Court for the Western District of Louisiana in Shreveport, Louisiana, by Parker & Waichman, a New York based firm that is heavily involved in pharmaceutical litigation throughout the country.

The suit alleges that in December 2003, the plaintiff 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. 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 taster 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).

Jerrold Parker, managing partner of Parker & Waichman stated: “Despite numerous reports that Zicam Cold Remedy nasal gel causes anosmia, Matrixx continues to market this product at the expense of consumers’ health. Furthermore, there is little evidence to suggest that Zicam is effective at relieving the symptoms of the common cold. Because the product has few benefits and poses major health risks, Matrixx should promptly remove it from the market.”

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.

Anosmia Zicam Side Effect Lawyer

Wed, 21 Dec 2005 00:00:00 -0800

Anosmia

Anosmia is the loss of the sense of smell. Anosmia may be temporary or permanent and can be caused by brain and or head injuries, illness and chemical exposure. Anosmia can even be deadly. For example, a person with Anosmia cannot smell smoke in a burning building or identify that the food they are eating is spoiled.

An estimated five million American adults suffer from disorders of taste and smell. More than 200 medical conditions and many prescription medications have been associated with olfactory changes and loss.

Zicam, a popular Zinc nasal cold gel, has been linked to a condition known as Anosmia. Zicam is an intranasal zinc solution. Intranasal zinc has been known to kill the ability to smell by both animals and people for many years. For years there had been no use of intranasal zinc in humans. However because Zinc products fall under the homeopathic provision of FDA laws, these products are not required to get FDA approval before they hit the market.

Therefore it’s not startling that studies revealed that Zinc nasal cold sprays and gels, like Zicam, not only have dangerous side effects but are ineffective against colds. While two placebo-controlled trials found that intranasal zinc gluconate modestly shortened the duration of cold symptoms two other placebo-controlled studies found intranasal zinc to be of no benefit at all.

In addition to Anosmia, there are other variations of loss of smell. Hyposmia is individuals reduced ability to smell and to detect odors.

Hyperosmia is an abnormally increased sensitivity to odors or an abnormally increased sense of smell. Parosmia involves a distortion of the sense of smell, the affected person reports smelling something other than the scent that is present.

Phantosmia involves olfactory hallucinations, there are no odorants present, but the affected person reports smelling something, generally unpleasant. Dysosmia is an impairment of the sense of smell.

If you or a loved one has used Zicam or any other zinc nasal sprays and been diagnosed Anosmia or any other side effects, please fill out the form at the right for a free case evaluation by a qualified drug side effects attorney.