Yourlawyer.com (Zicam News)

Matrixx Says FDA Won't Budge on Recalled Zicam Products

Wed, 28 Oct 2009 00:00:00 -0700

It looks like federal health regulators aren't backing down when it comes to recalled Zicam Nasal Cold Remedies. According to a Reuters report, Matrixx Initiatives Inc., the maker of Zicam products, said the Food & Drug Administration (FDA) is "unwilling to reverse its position regarding the warning letter" it issued over Zicam nasal remedies earlier this year.

In June, the FDA said it had received 130 reports of anosmia—loss of sense of smell—in people who had used the product. Following the FDA alert, Matrixx Initiatives recalled two of the products: Zicam Cold Remedy Nasal Gel and Zicam Cold Remedy Swabs. The company had already withdrawn Zicam Cold Remedy Swabs, Kids Size, the third product named by the FDA.

At the same time, the FDA issued a warning letter to Matrixx. In the letter, the FDA said Matrixx had failed to inform it of 800 anosmia reports linked to the recalled cold remedies. Matrixx has admitted that it did not pass along those reports to the FDA, but has maintained that its legal counsel advised it was not required to forward those reports to the agency. In the Warning Letter, the FDA warned the firm that the products cannot be marketed without agency approval and also stated that the three Zicam nasal remedies did not include adequate warnings about the risk of loss of sense of smell.

According to Reuters, Matrixx said in a regulatory filing with the Securities and Exchange Commission (SEC) that the FDA will not reverse its stance that the recalled Zicam products could not be marketed without agency approval. The filing said the company is currently evaluating its options. Matrixx also said it was reviewing the FDA's contention that it should have filed adverse event reports on several individual Zicam loss of smell cases, and that it would be responding soon.

Since the Zicam nasal cold remedy recall, Matrixx has been hit with several class action lawsuits filed on behalf of people who claim the products caused them to suffer anosmia. Earlier this month, the U.S. Judicial Panel on Multidistrict Litigation consolidated the Zicam litigation for pretrial proceedings in the District of Arizona for coordinated handling.

According to Reuters, the recent SEC filing also disclosed that two shareholder derivative lawsuits were filed in September against current and former Matrixx officers related to the recall.

Zicam Lawsuit Hearing Set for Thursday

Mon, 21 Sep 2009 00:00:00 -0700

Federal Zicam lawsuits could be consolidated in a Multidistrict Litigation (MDL). A hearing before the Judicial Panel on Multidistrict Litigation (JPML) will take place later this week.

Earlier this summer, the U.S. Food & Drug Administration (FDA) said it had received 130 reports of anosmia—loss of sense of smell—in people who had used the product. Following the FDA alert, Matrixx Initiatives recalled two of the products: Zicam Cold Remedy Nasal Gel and Zicam Cold Remedy Swabs. The company had already withdrawn Zicam Cold Remedy Swabs, Kids Size, the third product named by the FDA.

At the same time, the FDA issued a Warning Letter to Matrixx. In the letter, the FDA said Matrixx had failed to inform it of 800 anosmia reports linked to the recalled cold remedies. Matrixx has admitted that it did not pass along those reports to the FDA, but has maintained that its legal counsel advised it was not required to forward those reports to the agency. In the Warning Letter, the FDA warned the firm that the products cannot be marketed without agency approval and also stated that the three Zicam nasal remedies did not include adequate warnings about the risk of loss of sense of smell.

There are currently 10 Zicam anosmia lawsuits pending in 9 federal courts. These lawsuits allege that zinc gluconate, the active ingredient in recalled Zicam products, produces a caustic action on the nasal passages that, over time, can lead to a loss of smell.

On September 24, the JPML will hear arguments in Richmond, Virginia over whether all pending and future Zicam lawsuits should be consolidated in one federal court as an MDL. MDL is a procedure utilized in the federal court system to transfer to one federal judge all pending civil cases of a similar type filed throughout the United States. Such a consolidation avoids duplication of discovery, prevents inconsistent pretrial rulings, and conserves the resources of the parties, their counsel and the judiciary. The JPML was created in 1968, and since then, the Panel has consolidated hundreds of thousands of lawsuits, including litigation over asbestos, breast implants and other matters.

Multidistrict Litigation is not the same as a class action lawsuit. Each case in an MDL retains its own identity. If the MDL process does not resolve the cases, they are transferred back to the court where they originated for trial.

"Reformulated" Zicam Won't Replace Recalled Nasal Cold Remedies

Mon, 14 Sep 2009 00:00:00 -0700

Don’t expect to see new versions of Zicam Nasal Cold Remedies in stores anytime soon. According to a report on StreetInsider.com, rumors that Matrixx Initiatives will be reformulating the recalled Zicam products are false.

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. Earlier this summer, the U.S. Food & Drug Administration (FDA) said it had received 130 reports of anosmia—loss of sense of smell—in people who had used the product. Following the FDA alert, Matrixx Initiatives recalled two of the products: Zicam Cold Remedy Nasal Gel and Zicam Cold Remedy Swabs. The company had already withdrawn Zicam Cold Remedy Swabs, Kids Size, the third product named by the FDA.

At the same time, the FDA issued a Warning Letter to Matrixx. In the letter, the FDA said Matrixx had failed to inform it of 800 anosmia reports linked to the recalled cold remedies. Matrixx has admitted that it did not pass along those reports to the FDA, but has maintained that its legal counsel advised it was not required to forward those reports to the agency. In the Warning Letter, the FDA warned the firm that the products cannot be marketed without agency approval and also stated that the three Zicam nasal remedies did not include adequate warnings about the risk of loss of sense of smell.

Since the Zicam recall, Matrixx Initiatives has been named in several class action lawsuits filed by people who blame the nasal remedies for their loss of smell. It also faces a class action lawsuit filed by investors that stems from the recall.

According to StreetInsider.com, the recalled Zicam products accounted for 40 percent of the company's sales. The recall has also hurt demand for other Zicam products, such as melting tablets and liquids, which were not subject to the FDA warning. So it would make sense that Matrixx would want to return the recalled Zicam products to the market as soon as possible, and reassure consumers about the safety of all remedies sold under the Zicam name.

Since the recall, rumors have swirled that Matrixx was considering reformulating nasal version of Zicam. According to StreetInsider.com, shares of Matrixx have jumped every time this rumor has surface.

But a company spokesperson told StreetInsider.com that Matrixx has absolutely no intention of reformulating recalled Zicam products. Instead, the company is hoping to reach an agreement with the FDA that would allow recalled versions of Zicam back on the market. According to the report, no such agreement has been reached so far.

Zicam Lawsuits Filed in Texas

Thu, 13 Aug 2009 00:00:00 -0700

More Zicam lawsuits have been filed by people who claim the recalled nasal versions of the cold remedies caused them to lose their sense of smell.

Earlier this summer, the U.S. Food & Drug Administration (FDA) warned consumers not to use three Zicam nasal cold remedies. The agency said it had received 130 reports of anosmia—loss of sense of smell—in people who had used the product. Following the FDA alert, Matrixx Initiatives recalled two of the products: Zicam Cold Remedy Nasal Gel and Zicam Cold Remedy Swabs. The company had already withdrawn Zicam Cold Remedy Swabs, Kids Size, the third product named by the FDA.

At the same time, the FDA issued a Warning Letter to Matrixx. In the letter, the FDA said Matrixx had failed to inform it of 800 anosmia reports linked to the recalled cold remedies. Matrixx has admitted that it did not pass along those reports to the FDA, but has maintained that its legal counsel advised it was not required to forward those reports to the agency. In the Warning Letter, the FDA warned the firm that the products cannot be marketed without agency approval and also stated that the three Zicam nasal remedies did not include adequate warnings about the risk of loss of sense of smell.

Since the Zicam recall, Matrixx Initiatives has been named in several class action lawsuits filed by people who blame the nasal remedies for their loss of smell. It also faces a class action lawsuit filed by investors that stems from the recall.

The latest Zicam lawsuits were filed in the Marshall Division of the Eastern District of Texas. One lawsuit, filed on behalf of Sherrin Dawn King on July 31, claims King purchased and used Zicam's Allergy Relief Nasal Gel Swabs to treat a cold in January 2008. The lawsuit alleges that she used the product several days in a row and that by March she had lost all sense of smell. King claims that she still has not regained her sense of smell, and that her sense of taste has also been severely impaired.

The second lawsuit, filed in the same court on August 4, claims that Maria E. Head began using Zicam nasal swabs in the late spring of 2008. The complaint alleges that after using the swabs as directed, Head experienced "a significant burning and/or stinging sensation inside her nose." However, because that was "followed by a slight sense of relief from her symptoms," Head continued to use the product for several days, according to the suit. By the third day, Head alleges that she realized she could not smell and sought medical attention.

Both plaintiffs are seeking more than $75,000 in damages for pain and suffering, loss of enjoyment of life, physical injuries, medical expenses, attorney fees, pre-and post judgment interest.

Zicam Recall Blamed for Matrixx Loss

Tue, 11 Aug 2009 00:00:00 -0700

Matrixx Initiatives, the maker of recently recalled Zicam Nasal Cold Remedies, reported a larger-than expected first quarter loss of $22.8 million, or $2.49 per share. In a press release, the company blamed the fallout from the Zicam debacle for the disappointing results.

Earlier this summer, the U.S. Food & Drug Administration (FDA) warned consumers not to use three Zicam nasal cold remedies. The agency said it had received 130 reports of anosmia—loss of sense of smell—in people who had used the product. Following the FDA alert, Matrixx Initiatives recalled two of the products: Zicam Cold Remedy Nasal Gel and Zicam Cold Remedy Swabs. The company had already withdrawn Zicam Cold Remedy Swabs, Kids Size, the third product named by the FDA.

At the same time, the FDA issued a Warning Letter to Matrixx. In the letter, the FDA said Matrixx had failed to inform it of 800 anosmia reports linked to the recalled cold remedies. Matrixx has admitted that it did not pass along those reports to the FDA, but has maintained that its legal counsel advised it was not required to forward those reports to the agency. In the Warning Letter, the FDA warned the firm that the products cannot be marketed without agency approval and also stated that the three Zicam nasal remedies did not include adequate warnings about the risk of loss of sense of smell.

Since the Zicam recall, the company has been named in several class action lawsuits filed by people who blame the nasal remedies for their loss of smell. It also faces a class action lawsuit filed by investors that stems from the recall.

Matrixx is now reporting that revenues for the first quarter of fiscal year 2001 fell 18.7% year-over-year to $6.92 billion, falling short of analyst estimates of $8.96 million. The company took a $9 million charge from the Zicam recall, and a goodwill impairment charge of $23.9 million related to the recall.

"The FDA Warning Letter has had a material adverse impact on our business and generated significant publicity. The recall of two of our best-selling products has required us to take impairment charges, record reserves for customer returns, and withdraw our sales and earnings guidance for the year," Matrixx acting COO Bill Hemelt said a statement. "In addition, there has been an increase in legal activity on several fronts associated with this issue, including plaintiff attorneys soliciting for clients alleging anosmia due to our products; class action complaints alleging advertising and consumer fraud; and a class action securities lawsuit alleging public disclosure violations."

Zicam Maker Faces Investor Suit

Tue, 21 Jul 2009 00:00:00 -0700

Although Zicam maker, Matrixx Initiatives Inc., maintains its nasal cold remedy products are safe despite a massive recall, looming lawsuits and ongoing consumer reports of adverse reactions, another class action suit was just filed against the company on behalf of stockholders, BizJournals reports. The suit alleges Matrixx “failed to disclose material facts about its operational well-being and future prospects.”

Matrixx Initiatives is facing six other class action lawsuits connected to recalled nasal versions of its controversial cold remedy. Those lawsuits, which involve at least 117 plaintiffs, claim—among other things—that the company concealed or omitted material information regarding the safety of the nasal gel products. BizJournals also noted that Matrixx has been the subject of a number of consumer lawsuits that allege “product liability, negligence, fraud, and breach of warranties.”

Last month, the U.S. Food & Drug Administration (FDA) warned consumers not to use three Zicam nasal cold remedies. The agency said it had received 130 reports of anosmia—loss of sense of smell—in people who had used the product. Following the FDA alert, Matrixx Initiatives recalled two of the products: Zicam Cold Remedy Nasal Gel and Zicam Cold Remedy Swabs. The company had already withdrawn Zicam Cold Remedy Swabs, Kids Size, the third product named by the FDA.

Following announcements of the recalls and the initial six class actions lawsuits, Matrixx Initiatives stocks took a beating to less than $5 per share from over $19 before the FDA issued its notice. Matrixx shares plummeted a whopping 70 percent the day of the FDA warning.

At the time the FDA issued its Zicam warning, it also disclosed that Matrixx had failed to inform it of 800 anosmia reports linked to the recalled cold remedies. Matrixx has admitted that it did not pass along those reports to the FDA, but has maintained that its legal counsel advised it was not required to forward those reports to the agency. In a letter to Matrixx, the FDA warned the firm that the products cannot be marketed without agency approval and also stated that the three Zicam nasal remedies did not include adequate warnings about the risk of loss of sense of smell.

During a conference call to announce the Zicam alert, the FDA also said Matrixx Initiatives had received an additional 800 anosmia reports it hadn’t made available to the agency. The FDA discovered those reports during a routine inspection in May. The agency pointed out that under a 2007 regulation, Matrixx should have forwarded them to the FDA.

Despite its insistence that Zicam nasal remedies are safe, this is not the first time the products have caused problems for Matrixx. As we reported previously, in 2006 the company reached a settlement with 300 Zicam users who claimed the remedies had caused them to lose the sense of smell. Also, last month, Matrixx Initiatives said it received an informal inquiry from the Securities Exchange Commission (SEC) over the FDA’s warning on several Zicam nasal cold remedies.

Zicam is Matrixx’s most popular product line, and accounts for about 40 percent of its sales. In addition to the nasal remedies named in the FDA warning, the company also markets melting tablet and liquid forms of Zicam, which were not included in the warning.

Six Zicam Lawsuits Filed Over Loss of Smell

Tue, 07 Jul 2009 00:00:00 -0700

Zicam maker Matrixx Initiatives is facing six class action lawsuits connected to recalled nasal versions of the cold remedy. According to the Associated Press, Matrixx disclosed the lawsuits late last Thursday after the financial markets closed, but even though the news had time to sink in during the long holiday weekend, Matrixx's stock was still hammered when markets opened yesterday morning.

Last month, the Food & Drug Administration (FDA) warned consumers not to use three Zicam nasal cold remedies. The agency said had received 130 reports of anosmia - loss of sense of smell - in people who had used the product. Following the FDA alert, Matrixx Initiatives recalled two of the products - Zicam Cold Remedy Nasal Gel and Zicam Cold Remedy Swabs. The company had already withdrawn Zicam Cold Remedy Swabs, Kids Size, the third product named by the FDA.

According to the Associated Press, Matrixx announced late Thursday that it had been named in six class action lawsuits involving the three Zicam products. The lawsuits, which involved at least 117 plaintiffs, claim among other things that the company concealed or omitted material information regarding the safety of the nasal gel products.

At the time the FDA issued its Zicam warning, it also disclosed that Matrixx had failed to inform it of 800 anosmia reports linked to the recalled cold remedies. Matrixx has admitted that it did not pass along those reports to the FDA, but has maintained that it was advised by legal counsel that it was not required to forward those reports to the agency.

On Monday, investors reacted strongly to news of the Zicam lawsuits. Shares closed yesterday at $6.05, down 6.6% from the previous session. According to the Associated Press, Matrixx stock has ranged from $4.39 to $19.74 over the past year.

Matrixx continues to maintain that Zicam nasal products are safe, and said it will vigorously defend each lawsuit.

This is not the first time Matrixx has faced lawsuits over Zicam. 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.

Zicam Warning Attracts SEC Attention

Wed, 24 Jun 2009 00:00:00 -0700

Zicam maker Matrixx Initiatives Inc. said that it has received an informal inquiry from the Securities Exchange Commission (SEC) over last week's Food & Drug Administration (FDA) warning on several Zicam nasal cold remedies. Matrixx shares plummeted a whopping 70% the day of the FDA warning.

Last week, the FDA said it had received 130 reports of anosmia - loss of sense of smell - in people who had used three Zicam nasal remedies. Following the FDA alert, Matrixx Initiatives recalled two of the products - Zicam Cold Remedy Nasal Gel and Zicam Cold Remedy Swabs. The company had already withdrawn Zicam Cold Remedy Swabs, Kids Size, the third product named by the FDA.

In a letter to Matrixx, the FDA had warned the firm that the products cannot be marketed without agency approval. The warning letter also stated that the three Zicam nasal remedies did not include adequate warnings about the risk of loss of sense of smell.

During a conference call to announce the Zicam alert, the FDA also said Matrixx Initiatives had received an additional 800 anosmia reports it hadn’t made available to the agency. Those reports were discovered by the FDA during a routine inspection in May, and the agency said that under a 2007 regulation, Matrixx should have forwarded them to the FDA.

Zicam is Matrixx's most popular product line, and accounts for about 40% of its sales. In addition to the nasal remedies named in the FDA warning, the company also markets melting tablet and liquid forms of Zicam which were not included in the warning.

The recall could cost Matrixx as much as $10 million. The day of the FDA warning, Matrixx shares closed at $5.78, compared with $19.24 at its close the day before, The Wall Street Journal said.

According to The Wall Street Journal, the SEC has asked Matrixx to provide documents and information relating to the FDA warning. On Tuesday, the company said it didn't know what the SEC was looking into but would cooperate fully, the Journal said.

According to a Reuters report, Matrixx began formally notifying retailers, wholesalers and distributors of the Zicam recall today. However, Matrixx continues to say that it "vigorously disagrees" with the FDA over charges that the Zicam products were illegally marketed. The company also claims it was not required to report the additional 800 Zicam side effect complaints to the agency.

Despite its insistence that Zicam nasal remedies are safe, this is not the first time the products have caused problems for Matrixx. As we reported previously, in 2006 the company reached a settlement with 300 Zicam users who claimed the remedies had caused them to lose the sense of smell.

Zicam Recall Points to Potential Problems with Homeopathic Remedies

Mon, 22 Jun 2009 00:00:00 -0700

Last week's Zicam recall is raising some serious questions about the safety and regulation of homeopathic remedies. According to a new report by the Associated Press, more than 800 homeopathic ingredients were potentially implicated in health problems last year.

Last week, the Food & Drug Administration (FDA) said it had received 130 reports of anosmia - loss of sense of smell - in people who had used three Zicam nasal remedies. During a conference call to announce the Zicam alert, the FDA also said Matrixx Initiatives had received an additional 800 anosmia reports it hadn’t made available to the agency. Following the FDA alert, Matrixx Initiatives recalled two of the products - Zicam Cold Remedy Nasal Gel and Zicam Cold Remedy Swabs. The company had already withdrawn Zicam Cold Remedy Swabs, Kids Size, the third product named by the FDA.

Zicam products are considered homeopathic remedies. Homeopathy is generally defined as a system of medical treatment based on the use of minute quantities of remedies that in larger doses produce effects similar to those of the disease being treated. Homeopathic remedies like Zicam do not require FDA approval, and they do not have to be proven safe or effective before going on the market. However, the agency can intervene when there’s evidence a homeopathic drug may pose a risk to consumers.

Homeopathic medicines are very popular. According to the Associated Press, sales of homeopathic drugs hit $830 million last year. What's more, in 2007 such remedies were taken by more than 4 million Americans.

Most American's who use homeopathic drugs do so with the assumption that they are safe. But the Associated Press dug up some disturbing facts about these products. For instance, some homeopathic remedies contain far more alcohol than what is allowed in traditional medicines. In fact, the FDA has acknowledged that some homeopathic syrups far surpass 10 percent alcohol.

The Associated Press also found that least 20 ingredients used in conventional prescription drugs are also used in homeopathic remedies. This includes digitalis for heart trouble and morphine for pain. Homeopathic medicines have also been made from cancerous and diseased tissues, and poisons such as strychnine, arsenic or snake venom.

There's also very little evidence that homeopathic remedies are useful. In fact, according to the Associated Press, National Institutes of Health's alternative medicine center spent millions investigating homeopathic drugs, but quit when very little evidence was found to support their effectiveness.

Canadian Zicam Warning

Thu, 18 Jun 2009 00:00:00 -0700

Canadian health regulators are now warning consumers there not to use three Zicam nasal cold remedy products. The Health Canada Zicam alert comes just days after the Food & Drug Administration (FDA) warned consumers in the U.S. not to use the same three Zicam products because of reports linking them to anosmia - loss of sense of smell - in some people.

Matrixx Initiatives, the maker of Zicam, has since recalled two of the products - Zicam Cold Remedy Nasal Gel and Zicam Cold Remedy Swabs. The company had already withdrawn Zicam Cold Remedy Swabs, Kids Size, the third product named in the FDA alert.

Zicam products are popular over-the-counter nasal cold remedies. 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. Because they are considered homeopathic remedies, they did not require FDA approval. However, the agency can intervene when there’s evidence a homeopathic drug may pose a risk to consumers.

Earlier this week, the FDA said it had received 130 reports of anosmia in people who had used the three Zicam nasal remedies. 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 FDA said it was concerned that the loss of sense of smell may be permanent.

In addition to the FDA alert, Matrixx was issued a warning letter by the agency informing it that it could not market the Zicam products without FDA approval. The company was also cited for not including adequate warnings about the risk of anosmia associated with the Zicam Nasal cold remedies.

Now Health Canada is issuing a similar Zicam warning. The Zicam products named in the FDA alert are not authorized for sale in Canada, but Health Canada said they may have been brought into the country by travelers or purchased over the Internet. Drugs and natural health products that are authorized for sale in Canada will have either an eight-digit Drug Identification Number (DIN), a Natural Product Number (NPN) or a Homeopathic Medicine Number (DIN-HM) on the label. These numbers indicate that the products have been assessed by Health Canada for safety, effectiveness and quality.

Health Canada advises Canadians to contact the Health Products and Food Branch Inspectorate at 1-800-267-9675 if they find the Zicam nasal products in the Canadian marketplace.

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.

Users of Zicam Nasal Cold Remedies Could Lose Sense of Smell, FDA Warns

Tue, 16 Jun 2009 00:00:00 -0700

Consumers should not use three Zicam intranasal products because they may cause a loss of sense of smell, the Food & Drug Administration (FDA) warned today. The products affected by the FDA public health advisory are:

Zicam Cold Remedy Nasal Gel (15mL, NDC 62750-003-10)
Zicam Cold Remedy Swabs (20 swabs, NDC 67250-003-20)
Zicam Cold Remedy Swabs, Kids Size (20 swabs, NDC 67250-003-21)

Zicam, which also comes in melting tablet and liquid form, is Matrixx Initiatives' top-selling product line. The melting tablet and liquid varieties of Zicam are not included in this FDA alert.

Zicam products are popular over-the-counter nasal cold remedies. Zinc gluconate, the active ingredient is 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.

According to the FDA, it has received130 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 FDA is concerned that the loss of sense of smell may be permanent. Consumers should 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.

The Zicam intranasal zinc products are widely sold in pharmacies, other retail stores, and on the Internet. Zicam Cold Remedy Swabs, Kids Size, has already been discontinued, but the FDA is concerned that consumers may have the product in their home. The agency said it has special concerns regarding use of intranasal zinc in children. Children may experience a loss of sense of smell but may be less likely to communicate the condition.

The agency is warning consumers to stop using and discard or return the Zicam zinc-containing intranasal products. The FDA sent a warning letter to Matrixx Initiatives 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.

Zicam: Smelling Trouble?

Tue, 11 Apr 2006 00:00:00 -0700

The Federal Trade Commission (FTC) has launched an inquiry into the advertising and promotion of Zicam Cold Remedy and half a dozen similar over-the-counter cold products manufactured by Matrixx Initiatives of Phoenix. The company disclosed the investigation last week in a filing to the Securities and Exchange Commission, saying it was designed to determine whether Matrixx engaged in "unfair or deceptive acts or practices." Matrixx has been asked to provide information to the agency by April 27.

The Response

Matrixx spokesman Rob Murphy said that the company is cooperating with the FTC request, that it believes its advertising and promotions are accurate and comply with the law and that it stands by its products. John Mendenhall, director of the FTC's Cleveland office, where the inquiry was initiated, declined to comment or to confirm that an investigation is underway.

The Background

In January the company agreed to pay $12 million to settle 340 lawsuits brought by consumers who claim that Zicam Cold Remedy, the zinc nasal gel that is the company's flagship product, damaged or destroyed their sense of smell. Matrixx denied that Zicam was responsible and blamed a virus.

Last fall the company introduced a new control tip sprayer that prevents the gel from being forcefully expelled. The company said the new tip was a "product advancement," not a response to the hundreds of lawsuits it was then facing.

Around the same time, Matrixx launched a national advertising campaign on behalf of Zicam featuring testimonials from users, among them radio talk show host Rush Limbaugh.

Zicam Claims Continue to Mount Despite Settlement

Wed, 08 Mar 2006 00:00:00 -0800

A $12 million settlement with some 300 plaintiffs in a class action has not stopped claims being made against Zicam and its manufacturer, Matrix Corp. In fact, one attorney we spoke with indicated that the number of cases involving the over-the-counter (OTC) nasal spray is steadily mounting.

As we previously reported, in 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 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.”

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.

A lawsuit has been commenced by a major plaintiffs’ 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 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 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 settlement may have resolved some of the claims involving Zicam, the litigation only promises to expand and become far more expensive for the manufacturers of the OTC cold remedy..

Nasal gel caused loss of smell, suits claim

Fri, 03 Feb 2006 00:00:00 -0800

Hundreds of people across the country blame a common over-the-counter cold remedy for taking that joy from them: Zicam nasal gel, which is designed to ease the symptoms and shorten the duration of colds.

Last month, Matrixx Initiatives Inc., of Phoenix, maker of the popular Zicam products for colds, flu, sinuses and allergies, agreed to pay $12 million to settle lawsuits involving 340 plaintiffs. They said they suffered anosmia, or smell loss, after using the zinc-based gel, which is put into the nose with a pump.

The company admitted no wrongdoing and vowed to continue to "vigorously defend itself" in court. Sixty-one additional cases are pending, some involving Zicam’s nasal swabs. The company’s sprays and lozenges are not at issue.

No plaintiffs or attorneys returned phone calls during the last week.

Matrixx spokesman Robert J. Murphy said the company had spent $12 million in legal fees since the first Zicam productliability suit was filed about 2½ years ago. He called the settlement, announced in the midst of cold season, "strictly a business decision."

And business is good. Matrixx’s net sales rose 40 percent to more than $46 million for the nine months ending Sept. 30, 2005, compared with the same period in 2004.

The firm makes 22 products in the $3.5 billion retail cough and cold category and says its nasal gel is the only one on the market. Last year, Matrixx introduced a gentler spray tip to replace the pump, but the pump can still be found on store shelves in some areas.

Zicam products are widely considered "alternative," rather than mainstream, and are classified by the Food and Drug Administration as homeopathic remedies. That means they can be marketed as drugs but are held to a lower standard for safety and effectiveness.

Despite repeated requests for details of Zicam users’ complaints, spokeswoman Laura Alvey said only that "the FDA continues to monitor and review reports. If the situation warrants, the agency will take proper regulatory action."

According to the FDA’s adverse-event database, 133 Zicam users reported having problems in 2004, the latest year available.

Most involved the nasal gel and loss of smell, but because smell heavily influences taste, these people likely also suffered taste loss.

Zicam directions say to place the tip of the pump or swab just inside the nostril, apply the gel, and press lightly on the outside for about five seconds. "To avoid possible irritation," the pump box says, "do not sniff up gel."

The company blames its legal troubles on Bruce W. Jafek, an ear, nose and throat specialist at the University of Colorado School of Medicine, who in 2003 reported seeing 10 Zicam gel patients who had lost their sense of smell.

Paying Through the Nose

Tue, 31 Jan 2006 00:00:00 -0800

The manufacturer of Zicam Cold Remedy has agreed to pay $12 million to settle 340 lawsuits brought by consumers who claim the popular over-the-counter zinc nasal gel damaged or destroyed their sense of smell. The Phoenix-based manufacturer, Matrixx Initatives, says the agreement announced Jan. 19 is not an admission of liability, but rather an effort to end most of the litigation over the homeopathic remedy.

"The company still stands by the product, but this made good business sense," said Matrixx spokesman Robert J. Murphy. The agreement was announced jointly by the company and Arizona lawyer Charles S. Zimmerman, on behalf of a consortium of lawyers representing plaintiffs around the country.

In the past two years, Murphy said, Matrixx has spent about $12 million in legal fees defending its flagship product, which has sold more than 10 million bottles since its debut in 1999. Five months ago Matrixx settled the only Zicam lawsuit that has gone to trial, brought by a 42-year-old Los Angeles computer consultant, with an undisclosed payment.

Approximately 400 lawsuits have been filed against Zicam since 2003, some by users who say they lost their ability to smell and taste after using the product only once. Matrixx has denied the allegations, saying no study has linked the spray with loss of smell, also known as anosmia. The company says the likely culprit is a virus, the most common cause of anosmia.

Under the terms of the agreement, 95 percent of eligible plaintiffs must accept the Arizona settlement; the average payment after legal fees would be about $21,000. Zimmerman, who called the settlement "very fair and appropriate," said the amount would vary depending on the extent of injury determined by medical tests. The settlement does not cover about two dozen claims involving Zicam nasal swabs, which also contain zinc gluconate, or 32 lawsuits outside Arizona. Plaintiffs who reject the settlement are free to pursue their lawsuits, but are likely to have trouble finding a lawyer to represent them.

Zimmerman, a veteran product liability lawyer, and his colleagues have argued that Zicam destroyed delicate smell tissue when the drug's pump bottles drove the viscous gel into the top of the nose with propulsive force. Zinc is used to destroy smell in laboratory animals and can be toxic to the sense of smell in people.

Matrixx said the spray gel, which package instructions say is supposed to be used in the lower part of the nose, does not reach high enough to inflict damage.

Last fall Matrixx introduced a new "control tip sprayer" that prevents the spray gel from being forcefully expelled. Murphy called the new tip "a product advancement that has been in the works since 2001" that is "completely unrelated" to the litigation. Production of the old sprayer has been discontinued, but those containers will be sold until supplies are exhausted, he said.

Zimmerman said the redesign was a result of the litigation and will protect consumers.

At one downtown Washington drugstore last week, only packages with the old sprayer bearing an expiration date of January 2008 were on the shelf.

In recent months Matrixx has embarked on an expensive national advertising campaign featuring testimonials from consumers, including radio talk show host Rush Limbaugh.

Officials at the Food and Drug Administration (FDA) say they have received adverse reports involving Zicam, which was invented by several California entrepreneurs with credentials unusual for drug developers. (See "The Men Behind Zicam," at right.) The agency would not disclose the number of reports or comment further.

Because Zicam contains a naturally occuring mineral zinc which is generally recognized as safe, and because it is labeled as a homeopathic remedy, it is exempt from the regulations governing safety testing and manufacturing that apply to many drugs.

"This is not an FDA-regulated product," Zimmerman said.

Another over-the-counter homeopathic zinc nasal spray, Cold-Eeze, has been the target of a small number of anosmia lawsuits. It was pulled in 2004 after a year on the market by the manufacturer, which cited disappointing sales.

Since 2000, two case reports published in medical journals have reported anosmia after Zicam use. Medical experts who are not connected to the litigation say that it has been known since 1938 that zinc can harm smell tissue in high enough doses. A year earlier, Canadian doctors had used a zinc nasal solution to kill the sense of smell in children as part of an ill-fated experiment to prevent polio.

Murphy said Zicam is safe and effective, and produced in accordance with FDA regulations. He called the case reports "anecdotal. " The Canadian study, he said, is not relevant because it involved a different zinc solution.

But some experts say they aren't so sure and that the question is likely to linger because there is no incentive to study whether Zicam is linked to anosmia. (Research into the effectiveness of zinc gels, sprays and lozenges in fighting the common cold have yielded mixed results.)

"There's no way to tell whether anosmia is just chance or a cause-and-effect relationship," said Ronald Turner, a prominent University of Virginia cold researcher unconnected with the lawsuits, who published a study concluding that Zicam was ineffective in preventing or treating colds.

Turner conducted one of three company-financed studies of Zicam; two others found the product was effective. None reported unusual rates of anosmia.

Because the studies involved only a total of about 400 people, some side effects might not be recognized until large numbers of people used it, Turner said.

Several plaintiffs say they are disappointed by the Arizona settlement, but have been warned by plaintiff's lawyers that talking to the media could jeopardize the agreement or their participation in it.

"It's a pittance, but I'll take it since I don't have much choice," said one plaintiff, who asked that his name not be published. "I would really like to see them have a warning label on that product. Best of all, I'd like my sense of smell back." The settlement does not provide for a warning label, the parties said.
One Plaintiff's Story

Lisa Weatherington, a 50-year-old Army medical officer who lives in Bowie, is one of the 340 plaintiffs. Her case illustrates the difficulties inherent in determining what role, if any, Zicam played in her anosmia.

Weatherington said she used Zicam once two years ago to treat a burgeoning cold at the suggestion of her husband who said it worked for him. Seconds after spraying it, she recalled, she felt an intensely painful burning.

In early January 2004, Weatherington said, she realized she could no longer smell or taste anything. She said she called Matrixx to report the problem and was told the company had never heard of this problem -- although the first report of ansomia after Zicam use appeared in a medical journal in 2000 and the first lawsuit was filed in October 2003. Matrixx declined to comment on her case citing the pending litigation.

Several doctors have told Weatherington she probably will never regain her sense of smell. Her superiors have told her the problem could hamper her military career because it will prevent her deployment to places where she would need to detect poisonous fumes.

"I love food and I used to love to cook for my family, " said Weatherington who adds that she has gotten sick from eating spoiled shrimp she coudn't smell. "Sometimes I just feel like crying."

Robert I. Henkin, a neurologist who directs the Taste and Smell Clinic in Northwest Washington, said there's no way to know for sure whether Weatherington, whom he is treating, lost her sense of smell because of a virus or because she used Zicam.

Terence Davidson, director of the Nasal Dysfunction Clinic at the University of California at San Diego, said he was skeptical that Zicam could cause anosmia until he saw two patients in one week who were under 50 (most anosmia patients are older), had not had colds, and developed the condition hours after using the spray, an experience both described as deeply painful.

Post-viral anosmia typically occurs more gradually, said Davidson, adding that he has treated hundreds of such patients who seek treatment weeks after a severe cold. The burning pain many Zicam users describe, he said, is indicative of damage to sensitive olfactory tissue.

"The timing with these patients is very different than with post-viral anosmia patients," said Davidson, who has testified as an expert witness for several Zicam plaintiffs.

But Anthony F. Jahn, a New York otolaryngologist hired by Matrixx to review zinc studies, disputed Davidson's contentions.

The burning some patients report signals irritation the same thing that happens when a swimmer gets water up the nose--but does not mean damage has occurred, Jahn said. Zicam, he added, is too thick to reach high enough up in the nose to harm tissue. Said Jahn, "I don't see a mechanism by which this could happen." ·

The Men Behind Zicam

Tue, 31 Jan 2006 00:00:00 -0800

Like other scientific entrepreneurs, Robert Steven Davidson thought zinc might be a promising treatment for the common cold. But unlike many inventors of drugs, Davidson and his colleague Charles B. Hensley, who hold patents on Zicam, have unusual backgrounds.

Davidson received a bachelor's degree in 2004 from a "virtual" university, Excelsior College in Albany, N.Y. He lists himself as a PhD, a degree he obtained from an unaccredited and now-defunct university in Spain.

His colleague and co-inventor Hensley holds a doctorate in physiology from the University of Southern California and is currently chief executive officer of PRB Pharmaceuticals based in Cypress, Calif. Hensley recently received a warning letter from the Food and Drug Administration (FDA) about the sale over the Internet of an unapproved drug his company makes to treat bird flu. Hensley previously developed a weight-loss remedy that involves sniffing "specially developed aromas."

Davidson, who has contributed articles to Men's Fitness magazine, says his doctorate in biopharmaceutical project management and his MBA in international finance were earned at the American University of Asturias in Asturias, Spain, in the late 1990s. The school was closed in 2000 for violations of Spanish law, records show, and is considered a diploma mill by American authorities.

Davidson, who sold his interest in Zicam several years ago when he left to start another biotech firm, said he was unaware of any problems with the school in Spain. It is unusual to earn a doctorate before a bachelor's degree, he said in an interview, but his advanced degrees are legitimate. "I did work, a research paper and a dissertation."

He declined to discuss whether any safety questions arose during Zicam's development and testing.

Davidson said he met Hensley years ago at Cleveland Chiropractic College in Los Angeles, where he was taking classes and Hensley was a professor.

On Nov. 23, the FDA sent Hensley a letter about Vira 38, an antiviral compound marketed on PRB's Web site as effective in treating influenza, bird flu and SARS. The regulatory agency told Hensley he was violating federal law by selling an unapproved drug and warned that he and his company could face further legal action including "seizure of illegal products."

Hensley did not respond to e-mails or telephone calls.

Zicam Maker Settles Lawsuit Over Users' Loss Of Smell

Fri, 20 Jan 2006 00:00:00 -0800

A corporation that was the subject of a 7NEWS investigation has agreed to settle a massive lawsuit.

Matrixx Corp. makes the cold remedy Zicam. In 2004, 7NEWS Investigators revealed that some people who used Zicam's zinc nasal spray lost their sense of smell and taste.

On Friday, Matrixx agreed to pay $12 million in settlement awards and other charges to the 300 people who were part of a class-action lawsuit. Matrixx said that will cover about 90 percent of the outstanding claims.

Millions of people have used the nasal spray containing zinc gluconate, and most have not had any problems. However, 7NEWS found that hundreds of people who have used the product also felt an intense burning sensation in their nose, and subsequently lost their sense of smell.

At the University of Colorado Taste and Smell Clinic, Dr. Bruce Jafek continues to hear from patients who claim zinc gluconate has robbed them of their sense of smell.

Jafek said that he began hearing complaints about the Zicam nasal spray about five years ago. In 2003, Jafek's colleague, Dr. Miriam Linschoten, began testing patients who had used the Zicam nasal spray and suffered permanent loss of smell.

The maker of Zicam, Matrixx Corp., denied the product had anything to do with the consumer complaints.

But now, with the settlement, "it would seem the company finally realizes they have a problem with their product," Jafek said.

Jafek said, unfortunately, that means most patients who have experienced smell loss are not going to get it back.

"Approximately 25 to 30 percent have had some return of their sense of smell but that means however 60 to 70 percent have had no return of function," Jafek said. "In my opnion, the product is dangerous in putting zinc ions into the nose. If a person wishes to continue to use this product certainly they should be warned that they could lose their sense of smell. It's an uncommon problem but for the person who lose their sense of smell, it's devastating."

Matrixx Corp. has claimed correctly that, of the tens of millions of doses of the zinc product used, there is a only small percentage of complaints. While not admitting any fault, the company is paying $12 million to settle the claims.

And because the zinc nasal spray is so profitable, there is no indication Matrixx will take it off the market. So as Jafek says, "buyer beware."

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.

Parker & Waichman, LLP Files Suit Against Matrixx Initiatives, Inc., Zicam, LLC and Botanical Laboratories, Inc. on Behalf of Victim of Zicam Cold Remedy Nasal Gel -- MTXX

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

Parker & Waichman, LLP (www.yourlawyer.com) announced that it has filed suit against Matrixx Initiatives, Inc. (Nasdaq:MTXX), Zicam, LLC and Botanical Laboratories, Inc. on behalf of a victim who lost her senses of smell and taste after using Zicam Cold Remedy Nasal Gel. The suit was filed in the U.S. District Court for the Western District of Louisiana in Shreveport, Louisiana. For more information on Zicam Cold Remedy Nasal Gel, please visit www.yourlawyer.com/topics/overview/Zicam/.

In December 2003, the Plaintiff began using Zicam Cold Remedy Nasal Gel to relieve symptoms of the common cold. After using the Zicam Cold Remedy Nasal Gel as directed by the product's label, the victim began to experience a loss of her senses of smell and taste. She has never regained these senses completely. The victim has seen physicians who have diagnosed her as having sustained a partial loss of the senses of smell and taste. She continues to suffer from the loss of these two critical senses, and will likely continue to suffer from these injuries for the remainder of her life. The loss of the ability to smell is particularly dangerous because victims are often unable to detect fires, poisonous fumes and leaking gas.

"Despite numerous reports that Zicam Cold Remedy Nasal Gel causes Anosmia, Matrixx continues to market this product at the expense of consumers' health," commented Jerrold S. Parker, managing partner of Parker & Waichman, LLP. "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."

The Defendants include Matrixx (the successor corporation to Gumtech International, Inc.), Zicam (the successor limited liability company to Gel Tech, LLC) and Botanical Laboratories, Inc. Botanical Laboratories, Inc. manufactured and packaged Zicam Cold Remedy Nasal Gel for sale and distribution by Matrixx and/or Zicam. The suit alleges that the product label, promotional materials and advertisements used in conjunction with the sale of Zicam Cold Remedy Nasal Gel did not provide sufficient warnings and instructions about the risks and adverse side affects associated with the use of the product.

Defendants Matrixx and Zicam market Zicam Cold Remedy Nasal Gel as a remedy for the common cold. They claim it has been developed to reduce the severity and duration of the common cold. Zicam Cold Remedy Nasal Gel has never been approved by the United States Food and Drug Administration for safety or efficacy. It is estimated that the FDA has received hundreds of complaints about the Zicam spray, and additional complaints about a similar product called Cold-Eeze. In 2004, the FDA confirmed that it is investigating the link between zinc nasal sprays and the loss of smell. Zicam Cold Remedy Nasal Gel contains divalent ionized zinc in the form of zinc gluconate, which is listed as the product's active ingredient under the trade name of "zincum gluconium 2x." Zinc gluconate contains a divalent zinc ion. Zinc gluconate is a chemical compound characterized as a "zinc salt." If used as directed, the Zicam Cold Remedy nasal pump delivers the Zicam Cold Remedy Nasal Gel containing zinc gluconate to the user's nasal membranes.

About Parker & Waichman, LLP

Parker & Waichman, LLP is a leading products liability and personal injury law firm that represents plaintiffs nationwide, with offices in New York and New Jersey. Parker & Waichman, LLP has assisted thousands of clients in receiving fair compensation for injuries resulting from defective medications and medical devices. For more information on Parker & Waichman, LLP, please visit: (www.yourlawyer.com) or call 1-800-LAW-INFO (1-800-529-4636).

More information on this and other class actions can be found on the Class Action Newsline at www.primezone.com/ca.

CONTACT:
Parker & Waichman, LLP
Jason Mark, Esq.
Melanie H. Muhlstock, Esq.
(800) LAW-INFO
(800) 529-4636
info@yourlawyer.com
www.yourlawyer.com

Zicam Injury Lawyer Smell Loss Lawsuit Recall Side Effects

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

Zicam Injury Lawyers

Keywords: Zicam Injury Lawyer Smell Loss Lawsuit Recall Side Effects

If you use Zicam intranasal cold remedies and have lost your sense of smell - a condition known as anosmia - you should know that the zinc in these popular drugs is maybe to blame. Our Zicam injury lawyers are currently representing people who have been stricken with anosmia because of the zinc in Zicam intranasal products. If you are interested in filing a Zicam injury lawsuit, we urge you to get in touch with us immediately.

Anosmia is not a minor matter. In fact, it can be extremely dangerous, as the ability to smell alerts people to fires, poisonous fumes, leaking gas and other potentially fatal emergencies. In addition to completely losing their sense of smell, Zicam users who are stricken with anosmia are also robbed of their sense of taste. Because they can no longer enjoy food, many anosmia sufferers fail to take in adequate nutrition.

In June 2009, the Food & Drug Administration (FDA) warned consumers not to use three Zicam intranasal cold remedies: Zicam Cold Remedy Nasal Gel; Zicam Cold Remedy Swabs; and Zicam Cold Remedy Swabs, Kids Size. The warning came after the agency had received over one hundred reports of anosmia occurring in people using these three Zicam products. At the same time, the agency issued Matrixx Initiatives a warning letter that cited its failure to provide adequate warnings about the risks of these dangerous Zicam products.

The link between Zicam intranasal products and anosmia has been known for quite some time, yet Matrixx continued to market these drugs without warning consumers that they could cause some people to permanently lose their sense of smell. If you or someone you love has used Zicam intranasal products, and have since lost your sense of smell, you may be entitled to compensation. Please contact one of our Zicam injury lawyers right away to protect your legal rights.

FDA Zicam Public Health Alert

Zicam products are a popular line of homeopathic remedies used to decrease the duration of the common cold. Zicam became extremely popular when it first hit the market in 1999. In 2006, the products generated $96 million in sales for Matrixx. Unfortunately, these profits have come at a horrible cost to some Zicam users.

The active ingredient in Zicam products is zinc gluconate, which can have a caustic effect on the nasal passages. Over time, this caustic effect can cause Zicam intranasal users to lose their sense of smell. Unfortunately, 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 product could permanently rob them of their sense of taste and smell.

In its June 2009 public safety alert, the FDA said it had received 130 reports of anosmia associated with the use of Zicam Cold Remedy Nasal Gel; Zicam Cold Remedy Swabs; and Zicam Cold Remedy Swabs, Kids Size. During a conference call to announce the Zicam alert, the FDA also said Matrixx had received an additional 800 reports it hadn’t made available to the agency. The FDA warned consumers to stop using and discard or return the Zicam zinc-containing intranasal products.

At the time of the alert, Zicam Cold Remedy Swabs, Kids Size, had already been discontinued, but the FDA said it was concerned that consumers may still have the product in their home. The agency said it had special concerns regarding use of intranasal zinc in children. Children may experience a loss of sense of smell but may be less likely to communicate the condition.

The agency 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.

In addition to the public safety alert, the FDA also issued a warning letter to Matrixx. The agency informed the firm that these three Zicam products 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.

Zicam and Anosmia

The lack of anosmia warnings on Zicam is even more appalling when you consider the mountain of evidence that exists linking zinc to this condition. Medical reports from as far back as 1938 have found an association between zinc and damage to the tissues of the nose. Several studies have also found evidence of anosmia from products like Zicam, and there are real questions about the effectiveness of such remedies.

While two recent placebo-controlled trials found that products like Zicam modestly shortened the duration of cold symptoms, two other placebo-controlled studies found intranasal zinc to be of no benefit. In the most rigorously controlled of these studies, remedies like Zicam did not affect the severity or duration of cold symptoms in volunteers inoculated with rhinovirus, a common cause of colds.

These same studies also found evidence of anosmia and warned about the condition. The reports stated that since zinc-associated anosmia may be irreversible, intranasal zinc preparations like Zicam should be avoided. Considering such findings, it is hard to excuse the lack of warnings on Zicam products.

Despite all the evidence linking Zicam intranasal products to anosmia, Matrixx continued to insist they were safe. Yet in 2006, the company agreed to pay $12 million to approximately 300 people who were part of a class-action lawsuit. In spite of this settlement, many people have yet to receive compensation for their Zicam injuries, and continue to file lawsuits against Matrixx.

Legal Help for Victims of Zicam Injuries

Our Zicam injury lawyers are in the process of filing lawsuits on behalf of people who have suffered from anosmia as a result of Zicam intranasal products. If you or someone you love has used Zicam intranasal products and lost the sense of smell, our Zicam injury lawyers can help. Please fill out our online form or call 1 800 LAW INFO (1-800-529-4636) to discuss your potential Zicam injury lawsuit.