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Posts Tagged ‘Zicam’

Defective Drug Lawyers: Study Finds Zinc-Based Nasal Cold Remedies to Cause Loss of Smell

defective drug attorneys, defective drug lawyers, Defective Drugs, Zicam

July 20th, 2010: Law Blogger

Defective Drug LawyerRegular visitors of this blog might remember the summer of 2009 when we reported on the detriments zinc-based nasal remedies, particularly Zicam, a nasal remedy for the common cold manufactured by Matrixx Initiatives. Zicam was heavily advertised and taken by millions of people.

Then the US Food and Drug Administration (FDA) sent out a bulletin in June of 2009 warning, “Consumers to stop using and discard three zinc-containing Zicam intranasal products. The products may cause a loss of sense of smell.” It is a medical condition called Anosmia in which the patient loses the ability to perceive one or all scents depending on how serious it is. It has also known to be permanent in some cases.

In case you still have some of these products in your medicine cabinet, they were:

  • 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)

Of course Matrixx took a stance of total denial saying that there has been no causal evidence connecting their product Zicam to anosmia and that it has only proven to be helpful to all that have taken it. Now a study has come out, published in the Archives of Otolaryngology, one of the journals of the American Medical Association, that not only shows a causal connection, but also warns against all zinc based nasal remedies.

The Study

Nasal passageStudy author Dr. Terence Davidson, director of the University of California at San Diego Nasal Dysfunction Clinic first made a connection on the clinic level treating patients.

“In my practice, we started seeing people using the zinc nasal gel. They squirted it in, took a deep sniff and then had an incredibly intense burning sensation that lasted for several hours. When these people recovered, they found they had no sense of smell,” he said.

This and the findings of the FDA inspired him to conduct the clinical study. The analysis included 25 patients treated at the University of California, San Diego Nasal Dysfunction Clinic, which Davidson directs, who experienced loss of smell after using zinc nasal sprays or swabs to prevent or treat colds.

Along with colleague Wendy M. Smith, MD, Davidson applied the nine-point Bradford Hill causation environmental exposure statistical measure to assess the probability that the cold-remedy use caused the loss of sense of smell.

A statistician developed The Bradford Hill Criteria in 1965 because they wanted to establish a causal link between tobacco smoking and lung cancer. The method involves finding 9 key criteria necessary to find a causal link. It is a specific procedure with criteria that include:

  • Strength of the association (Is there a direct plausible connection?)
  • Consistency (Does it happen every time with every patient?)
  • Specificity (Whom does it effect?)
  • Timing (When and how long?)
  • Dose-response (Does the ailment get worse/better with weaker/stronger doses?)
  • Biological plausibility (Are certain people biologically predisposed to the ailment?)
  • Biological coherence (Are there biological triggers? How does it manifest itself?)
  • Experimental evidence
  • Analogy

Since it would be impossible, as well as unethical, to try to conduct a study where people with similar ailments are split between placebo groups and control groups that actually took the substance, they relied on the Bradford Hill Criteria through analysis of records and interviews to come to their conclusions.

The findings came back very similar to the conclusions of the FDA.

“Dr. Smith and I applied the criteria to zinc-induced anosmia and conclusively show that nasal zinc was the cause of the subsequent loss of smell,” said Davidson.

The patients seen by the researchers had a permanent loss of smell, but Davidson said there are likely people who have had lesser degrees of damage from these products as well. The study also yielded other unexpected results showing the efficacy of these products in reducing cold symptoms was “questionable”.

Defective Drug Lawyers

Defective Drug LawyersDavidson said that some of the people affected by the zinc-induced anosmia filed lawsuits against the manufacturers of these products. But yet Matrixx is not the only manufacturer and Zicam is not the only nasal product containing zinc.

You see, homeopathic low-dose remedies like nasal zinc aren’t subject to the same rules and regulations that prescription and over-the-counter medications are. Even though the FDA recommended consumers stop using the products and requested that the manufacturers stop selling them, some have stayed on shelves in various holistic and homeopathic retailers.

Oral zinc products are not associated with this problem and remain on the market.

Experts agree with the study and warn against nasal zinc-based products.

“I think this study was well-done, and I think intranasal zinc can impair the sense of smell. Does it happen all the time? No. Is it a rare event? No,” said Dr. Marc Siegel, an associate professor of medicine at the New York University School of Medicine and the NYU Langone Medical Center in New York City told US News and World Report.

“The problem is that it’s not FDA-regulated. If this were a prescription drug, you probably would’ve seen this [side effect] in the trials needed for approval,” he said.

In light of these findings you may have found that you replaced Zicam with just a lower dose, but just as detrimental homeopathic remedy that results in the same effect over a longer period of time. This is not a reasonable expectation or answer to your ailment. If this remedy was recommended to you by a medical professional you may choose to consult the practitioner and seek a second opinion.

If you have found that you or someone you know has suffered a severe loss of smell using a nasal product containing zinc then it is important that you find skilled legal representation that can get you the compensation you deserve. Call the defective drug lawyers at Phillips Webster for a free consultation on your legal options.

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The Dangers of Anosmia – Why the Zicam Issue Matters

anosmia, defective drugs attorneys, depression, FDA, gas leaks, injuries, loss of sense of smell, recall, side effects, Zicam

June 18th, 2009: Washington Law Blogger

When people hear about products being recalled and the FDA warning the public to stop using them because of a link to serious side effects, most would assume those side effects are more severe than the loss of the sense of smell. Anosmia, as it’s known in medical circles, is a condition that’s been diagnosed more than 130 times in consumers who had used certain Zicam products, and as a result it’s no longer available in retail outlets around the country.

We’ve been posting about the details of the issues involving Zicam lately, but some are wondering why anosmia is something to be concerned with, when other products have been known to cause cancer and death. However, basic research will tell anyone that the loss of the sense of smell, particularly if it’s permanent, can be a dangerous condition for several reasons.

When someone cannot smell, the most obvious danger it creates is that those people may not be able to sense dangers that include smoke from a fire or poisonous substances or gas leaks. However, there are other problems associated with anosmia, and they are directly correlated with the longer duration of this condition.

Those who cannot smell will often fall into a depression, as they understand that they are physically limited and are also concerned about their lack of ability to detect the dangers described above. Medical experts have also noted that those with anosmia will slowly lose weight as a result of a loss of appetite, and this can create many other medical problems that are high-risk in nature.

Ultimately, anosmia is a serious enough side effect that the FDA ordered the makers of Zicam to stop marketing the product and for Matrixx Initiatives, Inc., the manufacturer, to voluntarily pull the products from the shelves. If you or someone you love has been injured as a result of using Zicam, contact the defective drugs lawyers at Phillips & Webster today to schedule a free initial consultation.

Zicam Removed from Retail Shelves

ansomia, attorneys, FDA, injuries, Matrixx Initiatives, recall, side effects, warning, Zicam

June 17th, 2009: Washington Law Blogger

Yesterday, we alerted our readers to the fact that the US Food and Drug Administration (FDA) had issued a public warning regarding the dangers associated with several Zicam products. The agency also delivered a letter to Matrixx Initiatives, Inc. stating that they had to stop marketing these products unless they decided to put them through the normal FDA approval process that’s required of other medications.

Today, Matrixx Initiatives, Inc. responded by voluntarily pulling the products in question from retail shelves across the United States until the matter is resolved. The three specific products within the overall product line that were pulled include:

  • 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)

To reiterate the warning issued by the FDA yesterday, you should immediately stop using these products if you have them in your home.

The reason this issue arose is because the FDA received at least 130 reports of consumers using the Zicam products listed above and developing ansomia, which is the loss of the sense of smell. Consumers reported the development of this side effect soon after use, and while no duration of the condition has been defined, some reported that it took several months for their sense of smell to return.

It’s believed that zinc, one of the ingredients in Zicam products, was the reason for this side effect, as it has been known to create similar problems in people who have been exposed to it in the past. If you or someone you love has been harmed as a result of using Zicam, contact the defective drugs attorneys at Phillips & Webster immediately to schedule a free initial consultation.

Zicam Comes Under Fire From FDA

anosmia, attorneys, Defective Drugs, FDA, injuries, loss of smell, Matrixx Initiatives, US Food and Drug Administration, warning letter, Zicam

June 16th, 2009: Washington Law Blogger

Matrixx Initiatives is a company that manufactures, markets and distributes a product line known as Zicam, which is an over-the-counter product sold to help with the symptoms of the common cold. It’s sold in several forms, including nasal spray and swabs, and at least partially as a result of Zicam’s success, Matrixx Initiatives’ stock price has risen and held steady even in the current marketplace.

However, negative news hit the wire today as the US Food and Drug Administration announced that it has sent a letter to Matrixx Initiatives instructing it to stop marketing Zicam unless the company decides to file an application for a drug approval with the agency to continue to market these products. If the company does so, Zicam will be subject to the same testing and analytical standards as any other medication.

The reason for this letter is that the FDA received at least 130 reports of consumers using Zicam products and developing a condition known in medical circles as anosmia, which is the loss of the sense of smell. Some consumers reported this side effect after only one use, and no duration for this side effect has yet been established. Therefore, the FDA is demanding a closer look at the product and the presence of one ingredient in particular, zinc, which has been linked to this side effect in other contexts.

There were three Zicam products subject to the FDA’s letter:

  • 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)

If you are currently using Zicam products, the FDA advises you to stop doing so. If you or someone you love has been injured as a result of using these products, contact the defective drugs lawyers at Phillips & Webster today to schedule a free initial consultation.