Regular 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
Study 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
Davidson 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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