Dr Shezad Malik Law Firm has offices based in Fort Worth and Dallas and represents people who have suffered catastrophic and serious personal injuries including wrongful death, caused by the negligence or recklessness of others. We specialize in Personal Injury trial litigation and focus our energy and efforts on those we represent.

Zicam Lawsuit and the FDA

Has a Zicam nasal cold remedy robbed you of your sense of smell, and possibly the ability to taste? If so you have probably been stricken with a condition called anosmia – loss of sense of smell, sometimes accompanied by loss of sense of taste – related to the presence of zinc gluconate in Zicam intranasal cold remedies. Like thousands of other people who have used Zicam nasal gel or swabs, you probably had no idea that these products could be so dangerous.

Matrixx Initiatives, Inc. has had to remove several varieties of Zicam nasal cold remedies from the market because of their association with anosmia. The lawyers at our firm are currently representing scores of people in personal injury lawsuits who lost their ability to smell, and in some cases taste, after using a Zicam nasal gel or swab to treat or prevent a cold.

Ansomia is a serious matter – in fact, it can be quite devastating. Smell and taste alert people to fires, poisonous fumes, leaking gas, and spoiled food. The inability to detect such dangers can be life threatening. People who cannot enjoy their food after losing the sense of taste often do not take in adequate nutrition. This can lead to a host of serious health problems. Losing one or both of these senses can also leave victims vulnerable to depression and other mental disorders.

In June 2009, the Food & Drug Administration (FDA) warned consumers not to use three Zicam products – Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Swabs, and Zicam Cold Remedy Swabs, Kids Size – because of reports of anosmia in some users. At the same time, the FDA issued a warning letter to Matrixx Initiatives stating that the three Zicam products named in the alert could not be marketed without agency approval. The warning letter also stated that the products did not include adequate warnings about the risk of anosmia.

The victims of Zicam anosmia could have easily been spared their pain and suffering, as the association between Zicam nasal gels and swabs and the loss of smell and taste was well-known long before the FDA issued its alert. In fact, Matrixx Initiatives actually paid $12 million to settle a class action lawsuit in 2006 with hundreds of people who blamed Zicam for their inability to smell and taste. Yet even after the settlement, Matrixx Initiatives continued to market Zicam nasal swabs and gels as a safe remedy for the common cold.

Matrixx Initiatives have failed to provide adequate warnings about the dangerous side effects caused by Zicam intranasal cold remedies. Because so-called homeopathic remedies do not require FDA approval, Matrixx Initiatives did not adequately test Zicam products for safety and effectiveness. In addition to being extremely unsafe, there is little convincing evidence to support claims that Zicam prevents or significantly lessens the duration of a cold.

FDA Zicam Alert
In its 2009 safety alert, the FDA said it had received 130 reports of anosmia in people who used Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Swabs, and Zicam Cold Remedy Swabs, Kids Size. But that number only tells part of the story. In a conference call with reporters to discuss the Zicam safety alert, an FDA official said that Matrixx Initiatives had received 800 other anosmia reports that it had not turned over to the agency. Right now, there is no way to accurately estimate how many Zicam nasal remedy users have lost their sense of smell and taste because of these products.

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 a loss of sense of smell after later doses. The FDA also said it was concerned that the loss of sense of smell caused by these three Zicam products could be permanent.

Consumers were advised to contact their health care professional if they experience loss of sense of smell or other problems after using any zinc-containing products that are administered into the nose.

Following the FDA’s action, Matrixx pulled Zicam Cold Remedy Nasal Gel and Zicam Cold Remedy Swabs from the market. However, the company defiantly continued to insist that the action the FDA took in regards to Zicam nasal remedies was “unwarranted.”

Zicam and Anosmia
Approximately two to five million American adults suffer from disorders of taste and smell. Anosmia is a lack of functioning olfaction, or in other words, an inability to perceive smells. It can be either temporary or permanent. Without a sense of smell, taste suffers as well. According to the Anosmia Foundation, the disorder can be diagnosed by doctors using scratch-n-sniff odor tests or by using commonly available odors such as coffee, lemon, grape, garlic, vanilla and cinnamon.

The active ingredient in Zicam products is zinc gluconate, which can have a caustic effect on the nasal passages. The FDA did not require that Zicam undergo clinical testing for safety because it is considered a homeopathic remedy. This, coupled with a lack of warnings about the potential health consequences of zinc, left many Zicam users unaware that the products could permanently rob them of their sense of taste and smell.

Zicam users should have been warned that zinc gluconate in the nasal products could damage their nasal passages enough to destroy their sense of smell. The link between intranasal zinc gluconate preparations was known as far back as the 1930s. At that time, zinc spray was used to treat approximately 5,000 children during a polio outbreak. The theory was that zinc would kill the polio virus as it entered the nasal cavity. In reality, the spray was useless against the polio virus and approximately 25 percent of the children treated developed varying degrees of the loss of taste and smell.

Matrixx first marketed Zicam products in 1999, and that year the FDA received the first reports of anosmia in people who had used nasal varieties of Zicam. Despite hundreds of reports linking Zicam products to anosmia, and despite already having paid millions to settle Zicam claims in 2006, Matrixx Initiatives has inexplicably continued to maintain the remedies are safe. It even continued to deny the link between anosmia and Zicam nasal swabs and gel when it withdrew the products from the market following the 2009 FDA warning.

Zicam Lawsuit
If you used any Zicam nasal gel or swab cold remedy, and experienced either a temporary or permanent loss of your sense of smell, and possibly your sense of taste, you may be entitled to compensation. Please contact the Fort Worth Texas Personal Injury Attorney Dr. Shezad Malik. For a no obligation, free case analysis, please call 817-255-4001 or Contact Me Online.

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