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37-675: Zicam was invented and developed by Charles B. Hensley and Robert Steven Davidson in the mid 1990s, working on the ICAM-1 synthesis success of the Hafdua Laboratory in Haifa, Israel , under the direction of Mich Segal and Avram Satz, and is produced, marketed and sold by Zicam, LLC, a wholly owned subsidiary of Matrixx Initiatives, Inc., an American company. In 2009, the U.S. Food and Drug Administration (FDA) and Health Canada advised consumers to avoid intranasal versions of Zicam Cold Remedy because of

74-458: A degenerative brain disease such as Parkinson's disease and Alzheimer's disease . Another specific cause of permanent loss could be from damage to olfactory receptor neurons because of use of certain types of nasal spray ; i.e., those that cause vasoconstriction of the nasal microcirculation. To avoid such damage and the subsequent risk of loss of smell, vasoconstricting nasal sprays should be used only when absolutely necessary and then for only

111-518: A detailed history, including possible related injuries, such as upper respiratory infections or head injury. The examination may involve nasal endoscopy for obstructive factors such as polyps or swelling. A nervous system examination is performed to see if the cranial nerves are affected. On occasion, after head traumas, there are people who have unilateral anosmia. The sense of smell should be tested individually in each nostril. Many cases of congenital anosmia remain unreported and undiagnosed. Since

148-469: A long period of time, and, in some cases, by ciliopathy , including ciliopathy due to primary ciliary dyskinesia . The term derives from the Neo-Latin anosmia , based on Ancient Greek ἀν- ( an -) + ὀσμή ( osmḗ 'smell'; another related term, hyperosmia , refers to an increased ability to smell). Some people may be anosmic for one particular odor, a condition known as "specific anosmia". The absence of

185-482: A loss of smell, but did not turn those over to the FDA as they did not feel they were required to do so. The FDA disagreed, and requested copies of any reports that had associated anosmia with intranasal Zicam Cold Remedy. The FDA also issued a Warning Letter to Matrixx, stating that the products cannot be marketed without FDA approval. The company initially refused to recall the products but later said that they would withdraw

222-529: A number of harmful effects. People with sudden onset anosmia may find food less appetizing, though congenital anosmics rarely complain about this, and none report a loss in weight. Loss of smell can also be dangerous because it hinders the detection of gas leaks , fire, and spoiled food. Misconceptions of anosmia as trivial can make it more difficult for a patient to receive the same types of medical aid as someone who has lost other senses, such as hearing or sight. Many experience one sided loss of smell, often as

259-423: A relationship between use of amiodarone to the development of anosmia. Chemosensory disturbances, including loss of smell or taste, are the predominant neurological symptom of COVID-19 . As many as 80% of COVID-19 patients exhibit some change in chemesthesis , including smell. Loss of smell has also been found to be more predictive of COVID-19 than all other symptoms, including fever, cough, or fatigue, based on

296-419: A result of minor head trauma. This type of anosmia is normally only detected if both of the nostrils are tested separately. Using this method of testing each nostril separately will often show a reduced or even completely absent sense of smell in either one nostril or both, something which is often not revealed if both nostrils are simultaneously tested. Losing an established and sentimental smell memory (e.g.

333-440: A risk of damage to the sense of smell , leading the manufacturer to withdraw these versions from the U.S. market. However, in recent years, they have returned to market with both nasal swabs and also dissolving/chewable tablets and nasal spray and oral mist forms, some with zinc, some without. In 2020, the brand was purchased by Church & Dwight for $ 530 million. Because this product is a "homeopathic" over-the-counter drug, it

370-423: A short amount of time. Non-vasoconstricting sprays, such as those used to treat allergy-related congestion, are safe to use for prescribed periods of time. Anosmia can also be caused by nasal polyps. These polyps are found in people with allergies, histories of sinusitis, and family history. Individuals with cystic fibrosis often develop nasal polyps. Amiodarone is a drug used in the treatment of arrhythmias of

407-507: A six-year investigation, Hensley was charged with federal violations stemming from his marketing a drug for bird flu without FDA approval. Subsequently, all charges save one misdemeanor were dropped. Hensley was sentenced to three years' probation and ordered to pay a $ 5,000 fine and perform 400 hours of community service. In 2016, Hensley and his partners acquired the registered trademark for Desilu , Lucille Ball and Desi Arnaz 's defunct production company. In 2018, Desilu Studios filed

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444-519: A survey of 2 million participants in the UK and US. Google searches for "smell", "loss of smell", "anosmia", and other similar terms increased since the early months of the pandemic, and strongly correlated with increases in daily cases and deaths. Research into the mechanisms underlying these symptoms is currently ongoing. Many countries list anosmia as an official COVID-19 symptom, and some have developed "smell tests" as potential screening tools. In 2020,

481-603: A trademark infringement lawsuit against CBS over the Desilu mark. CBS subsequently filed a counter-suit against Hensley, Desilu Corporation and Desilu Studios. On August 10, 2022, federal prosecutors in Los Angeles indicted Hensley on fraud and identity theft charges, alleging he used the Desilu name to scam investors. Hensley has been charged with 11 counts of wire fraud and one count of aggravated identity theft . Prosecutors said Hensley collected $ 331,000 from investors, money that

518-587: Is exempt from a number of the requirements ordinarily applicable to OTC drug products, provided it conforms to the standards of the Homeopathic Pharmacopeia of the United States (HPUS) and is labeled as a homeopathic product. The only biologically active ingredients present in Zicam Cold Remedy are zinc acetate (2X = 1/100 dilution ) and zinc gluconate (1X = 1/10 dilution). Other sources list

555-431: Is present from birth and is typically caused by genetic factors or developmental abnormalities of the olfactory system. While acquired anosmia may have potential treatments depending on the underlying cause, such as medications or surgery, congenital anosmia currently has no known cure, and management focuses on safety precautions and coping strategies. Anosmia can be due to a number of factors, including inflammation of

592-591: The National Advertising Division recommended that Matrixx Initiatives cease advertising claims suggesting "its homeopathic Zicam Cold Remedy products prevent users from catching a cold." However, the NAD concluded that imagery of the “cold monster” was unlikely to imply that taking Zicam would, in fact, reduce the severity of a cold. The advertiser’s voluntary discontinuance of the language “concentrated formula” from its Zicam ULTRA advertising and product packaging

629-488: The nasal mucosa , blockage of nasal passages , or destruction of temporal lobular tissue. Anosmia stemming from sinus inflammation is due to chronic mucosal changes in the lining of the paranasal sinus and in the middle and superior turbinates . When anosmia is caused by inflammatory changes in the nasal passageways, it is treated simply by reducing inflammation. It can be caused by chronic meningitis and neurosyphilis that would increase intracranial pressure over

666-439: The smell of grass , of the grandparents' attic, of a particular book, of loved ones, or of oneself) has been known to cause feelings of depression . Loss of the ability to smell may lead to the loss of libido , but this usually does not apply to those with olfactory dysfunction at birth. Often people who have loss of smell at birth report that they pretended to be able to smell as children because they thought that smelling

703-530: The FDA had associated a serious risk of anosmia with them. The advisory did not implicate other Zicam products. The FDA indicated that it had received reports of a loss of smell from approximately 130 Zicam Cold Remedy users since 1999. The FDA voiced concern that the loss of smell may be long-lasting or permanent, while the condition for which these Zicam products are marketed—the common cold—typically resolves on its own without lasting problems. The manufacturer stated that it had received an additional 800 reports of

740-549: The Global Consortium for Chemosensory Research, a collaborative research organization of international smell and taste researchers, formed to investigate loss of smell and related chemosensory symptoms. Studies have indicated that patients who presented with anosmia during the acute phase of COVID-19 are more likely to develop changes in decision-making, exhibiting more impulsive responses, which are associated with functional and structural brain changes. Diagnosis begins with

777-442: The U.S. FDA information. Charles B. Hensley Charles B. Hensley is an American businessman. In 1997 he invented and developed Zicam , a homeopathic patent medicine for the common cold . In 1997, he invented and developed Zicam , a homeopathic patent medicine for the common cold . In 2001, he formed PRB Pharmaceuticals, Inc. to develop antiviral drugs aimed at emerging viral disease . In 2011, after

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814-456: The anosmia. A prednisone regimen is adjusted based on the degree of the thickness of mucosa, the discharge of oedema and the presence or absence of nasal polyps. However, the treatment is not permanent and may have to be repeated after a short while. Together with medication, pressure of the upper area of the nose must be mitigated through aeration and drainage. Anosmia caused by a nasal polyp may be treated by steroidal treatment or removal of

851-405: The company. Through Freedom of Information Act (FOIA) filings, Matrixx has requested the FDA to provide the research and evidence that led them to request the withdrawal of Zicam swabs. The company said that "fundamental fairness" required a clear explanation of the FDA's methodology and analysis. On June 19, 2009, Health Canada , in a foreign product alert, also issued a similar warning based on

888-511: The disorder is present from birth the individual may have little or no understanding of the sense of smell, hence is unaware of the deficit. It may also lead to reduction of appetite. Though anosmia caused by brain damage cannot be treated, anosmia caused by inflammatory changes in the mucosa may be treated with glucocorticoids . Reduction of inflammation through the use of oral glucocorticoids such as prednisone, followed by long term topical glucocorticoid nasal spray, would easily and safely treat

925-492: The general population. In contrast, the FDA had reported that cases of anosmia associated with intranasal Zicam Cold Remedy products were in excess of those seen with other nasal remedies for the common cold, and that cases associated with intranasal zinc presented more rapidly, and with different symptoms, than did unrelated cases. In addition, the FDA's warning letter prompted the Securities and Exchange Commission to investigate

962-403: The heart. A clinical study demonstrated that the use of this drug induced anosmia in some patients. Although rare, there was a case in which a 66-year-old male was treated with amiodarone for ventricular tachycardia . After the use of the drug he began experiencing olfactory disturbance, however after decreasing the dosage of amiodarone, the severity of the anosmia decreased accordingly, suggesting

999-472: The homeopathic industry support its cold-reduction claims: Center of Integrative Medicine and Department of Infections Diseases, Cleveland Clinic Foundation, Cleveland OH. Some of the homeopathic ingredients used in the preparation of Zicam are galphimia glauca histamine dihydrochloride (homeopathic name histaminum hydrochloricum), luffa operculata , and sulfur . In 2006, Matrixx Initiatives paid $ 12 million to settle 340 lawsuits from Zicam users who said that

1036-507: The ionic zinc content as "33 mmol/L of zincum gluconium". Zicam is marketed as a homeopathic product which the maker claims can shorten the duration of a cold and may reduce the severity of common cold symptoms. It is marketed in accordance with the Homeopathic Pharmacopoeia of the United States, a private organization not linked to nor regulated by any part of any government. Various non-scientific private studies done by and for

1073-482: The nose or by brain injury in which there is damage to the olfactory nerve or damage to brain areas that process smell (see olfactory system ). The lack of the sense of smell at birth, usually due to genetic factors, is referred to as congenital anosmia . Family members of the patient with congenital anosmia are often found with similar histories; this suggests that the anosmia may follow an autosomal dominant pattern. Anosmia may very occasionally be an early sign of

1110-457: The polyp. Although very early in development, gene therapy has restored a sense of smell in mice with congenital anosmia when caused by ciliopathy . In this case, a genetic condition had affected cilia in their bodies which normally enabled them to detect air-borne chemicals, and an adenovirus was used to implant a working version of the IFT88 gene into defective cells in the nose, which restored

1147-495: The product destroyed their sense of smell (medically termed anosmia ), although the company did not admit fault. As of 2009, "hundreds more such suits have since been filed." In 2005, the International Brotherhood of Electrical Workers pension fund sued Matrixx Initiatives for misrepresenting the stock by not reporting the risks of Zicam. In Matrixx Initiatives, Inc. v. Siracusano , the U.S. Supreme Court ruled that

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1184-466: The products from sale and that, "based on the FDA’s recommendation, consumers should discard any unused product or contact Zicam ... to request a refund." On June 24, 2009, Matrixx recalled all affected products. The company maintained that most cases of anosmia are due to the common cold itself, and that complaints of anosmia among Zicam Cold Remedy users are unlikely to be more numerous than those expected among

1221-403: The sense of smell from birth is known as congenital anosmia . In the United States, 3% of people aged over 40 are affected by anosmia. Anosmia is a common symptom of COVID-19 and can persist as long COVID . Anosmia is the inability to smell . It may be partial or total, and can be specific to certain smells. Reduced sensitivity to some or all smells is hyposmia . Anosmia can have

1258-523: The union's suit could go forward. In 2014, Yesenia Melgar commenced an action entitled Melgar v. Zicam LLC, et al. Melgar claimed that Zicam deceived customers by falsely representing that Zicam products "reduce the duration and severity of a cold." The court allowed the case to become a class action suit that included a variety of Zicam products. In 2018, a settlement was reached. Zicam agreed to pay $ 16,000,000 to people that had purchased Zicam products between Feb. 15, 2011 and June 5, 2018. In April 2013,

1295-567: Was noted and appreciated. It was found that Zicam provided a reasonable basis for the use of “Ultra” for Zicam products that contain more of the active ingredient per dosage unit than their original counterparts and require consumers to take fewer doses per day. On June 16, 2009, the FDA advised consumers to discontinue use of three nasally administered versions of Zicam Cold Remedy—Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Nasal Swabs, and Zicam Cold Remedy Swabs, Kids Size (a discontinued product)—because

1332-482: Was something that older/mature people could do, or did not understand the concept of smelling but did not want to appear different from others. When children get older, they often realize and report to their parents that they do not actually possess a sense of smell, often to the surprise of their parents. A temporary loss of smell can be caused by a blocked nose or infection. In contrast, a permanent loss of smell may be caused by death of olfactory receptor neurons in

1369-569: Was used for his personal expenses including trips to Las Vegas. Anosmia Anosmia , also known as smell blindness , is the loss of the ability to detect one or more smells . Anosmia may be temporary or permanent. It differs from hyposmia , which is a decreased sensitivity to some or all smells. Anosmia can be categorized into acquired anosmia and congenital anosmia . Acquired anosmia develops later in life due to various causes, such as upper respiratory infections, head trauma, or neurodegenerative diseases. In contrast, congenital anosmia

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