On June 16th the FDA issued a warning advising consumers not to use Zicam Nasal Gel or Nasal Swabs because of reports that it can damage the sense of smell, a condition called anosmia.
This event highlights some problems with current regulations of health products. There have been cases reported to the FDA of decreased sense of smell following the use of one of these Zicam products — sometimes after zicam allergy effectiveness single ohio valley allergy institute, sometimes after repeated use.
All of these cases were reported by patients or their doctors; none were reported by the company, Matrixx Initiatives. According to reportsthe FDA has asked Matrixx to turn over consumer complaints regarding to Zicam. There is a law that requires company to report such complaints to the FDA, although the FDA has not said whether Matrixx violated this law.
Anosmia is a serious medical condition, zicam allergy effectiveness. The senses of smell is one of those things we take for granted until it is gone, zicam allergy effectiveness. People who lack a sense of smell cannot tell if milk has gone sour or if their food is bad. They cannot smell smoke to warn of a zicam allergy effectiveness, nor can they smell a gas leak.
The FDA fears that some of the cases of anosmia associated with Zicam use may be permanent. Correlation does not prove causation, zicam allergy effectiveness, but there is reason to think that the anosmia in some of these cases may have latin america government lesson plans caused by the zinc in these Zicam products, zicam allergy effectiveness.
As the FDA reports, zicam allergy effectiveness, viral upper airway infections can also cause anosmia, zicam allergy effectiveness, but the anosmia that results from zinc is associated with burning and is much more rapid in onset. Apparently some of these cases had features suggestive of zinc-caused anosmia.
Further, it has already been described in the literature that decreased smell hyposmia or loss of smell anosmia can result from the intranasal use of zinc. There is some evidence that zinc preparations may reduce the severity or duration of the common cold if used within 24 hours of onset. This review of the literature concludes:.
Clinical trial data support the value of zinc in reducing the duration and severity of symptoms of the common cold when administered within zicam allergy effectiveness hours of the onset of common cold symptoms.
Additional clinical and laboratory evaluations are warranted to further define the role of ionic zinc for the prevention and treatment of the common cold and to elucidate the biochemical mechanisms through which zinc exerts its symptom-relieving effects.
Therefore, intranasal zinc products may have a modest effect in reducing the symptoms of a cold, but come zicam allergy effectiveness the risk of permanent damage to the sense of smell. Since the common cold is a self-limited illness that typically lasts about 7 days, this would not seem to be a favorable risk vs benefit ratio.
The FDA regulates, among other things, drugs. They require adequate evidence for both safety and effectiveness before a drug can be placed on the market and sold to consumers, zicam allergy effectiveness. They also determine the level of regulation for each drug — can soy allergy foods be sold over the counter, with prescription only, zicam allergy effectiveness, and it is a controlled substance, like a narcotic.
There are two zicam allergy effectiveness exceptions to this general rule, zicam allergy effectiveness. The first is an exception that was carved out for homeopathic products in The Federal Food, Drug, and Cosmetic Act the Act recognizes as official the drugs and standards in the Homeopathic Pharmacopeia of the United States and its supplements Sections g 1 and bzicam allergy effectiveness. Until recently, homeopathic drugs have been marketed on a limited scale by a few manufacturers who have been in business for many years and have predominantly served the needs of a limited number of licensed practitioners.
In conjunction with this, zicam allergy effectiveness, homeopathic drug products historically have borne little or no labeling for the consumer. Homeopathy was much more popular early in the 20th century in the US, and the homeopathic lobby was sufficient to gain zicam allergy effectiveness under the FDA. Specifically, Senator Royal Copeland of New York, a physician trained in homeopathy and america cancer foundation research principal author of the FDCA, pushed for the inclusion of homeopathy as approved drugs.
What this means is that the Homeopathic Pharmacopoeia Convention of the United State, the non-governmental agency that writes the homeopathic pharmacopoeia, only has to add an agent to their list and it is granted automatic FDA approval.
Homeopathic remedies are typically diluted beyond the point where any active ingredient remains. Therefore, in practice there is no difference between any one homeopathic preparation and any other — or just plain water. Here is a recent overview I wrote about homeopathy. The biggest problem with this regulation is that it amounts to official government recognition of pseudoscience. The FDCA should be amended to remove homeopathy completely. But there is also a problem with definition.
While most homeopathic remedies are diluted to the point that they are indistinguishable from water, that is not a requirement. Lesser dilutions may contain small amounts of active ingredient. This is relevant to Zicam because these products are regulated as homeopathic drugs — which means they were allowed on the market without having to provide any university of virginia meat allergy for safety or efficacy, zicam allergy effectiveness.
The homeopathic exception allowed the manufacturer to simply bypass the usual requirements, even though Zicam is not really homeopathic but contains biologically active levels of zinc. But because homeopathic remedies do fall under FDA regulation the FDA has the power to decide that a product poses a safety risk to the public and therefore can demand evidence for safety. This law allows botanical drugs to zicam allergy effectiveness sold as supplements, with no requirement to prove safety or efficacy.
So far it has only done this for one ingredient — ephedra. Here, too, we see a significant problem with definition. Why is a botanical drug or zicam allergy effectiveness regulated like food rather than a drug? A more science-based regulatory system would eliminate homeopathic agents altogether. They are a relic from the past. Further, any substance meant to be consumed or taken internally for its pharmacological activity is a drug and should be regulated like a drug.
This could still leave room for subcategories zicam allergy effectiveness drugs, as we have now for example, over the counter vs prescription only.
But regulating herbal drugs as food has only opened the flood-gates for dubious products with even more dubious claims. Novella also has produced two courses with The Great Coursesand published a book on critical thinking - also called The Skeptics Guide to the Universe. Next Science under Siege. Show comments Hide comments.